Method and apparatus for improving human balance and gait and preventing foot injury

• US 20040173220A1
• Filed: 03/08/2004
• Published: 09/09/2004
• Est. Priority Date: 03/06/2003
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation), Trustees of Boston University
• Original Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Inventors: Priplata, Attila A., Niemi, James B., Kleshinski, Stephen J., Collins, James J., Harry, Jason D.
• Granted Patent: US 8,308,665 B2
• Time in Patent Office: Days
• US Class Current: 128/892
• CPC Class Codes: A43B 13/00 Soles; Sole-and-heel integral units
• CPC Class Codes: A43B 17/00 Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
• CPC Class Codes: A43B 19/00 Shoe-shaped inserts; Inserts covering the instep
• CPC Class Codes: A43B 3/34 with electrical or electronic arrangements
• CPC Class Codes: A43B 7/00 Footwear with health or hygienic arrangements
• CPC Class Codes: A43B 7/1464 with adjustable pads to allow custom fit
• CPC Class Codes: A61F 5/0111 for the feet or ankles
• CPC Class Codes: A61F 5/14 Special medical insertions for shoes for flat-feet, club-feet or the like
• CPC Class Codes: A61H 1/00 Apparatus for passive exercising A61H5/00 takes precedence; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
• CPC Class Codes: A61H 2205/125 Foot reflex zones
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

Abstract

A method and wearable system and for enhancing human balance and gait and preventing foot injury through neurological stimulation of the foot and the ankle. Subthreshold stimulation for neurosensory enhancement is provided via electrodes or vibrational actuators, or combination thereof, disposed in or on a wearable a platform, such as an insole, sock shoe, removable shoe insert, or applied without the support of a platform, to the skin surface of an individual. Suprathreshold stimulation for therapeutic purposes, such as improving blood flow, is also provided by the vibrational actuators. The actuators and electrodes are driven by bias signals generated by a bias signal generator that is coupled to a controller. The signal generator under the control of the controller is adapted to generate a non-deterministic random signal, a repetitive pattern or series of patterns. The controller optionally includes a communication port for interfacing with an external computer for purposes of optimizing and programming the controller. The wearable system is powered by a power source.

Claims

1. A wearable system for neurological stimulation of a human foot, the system comprising:

a platform having at least one bias signal inputting means adapted to apply a stimulation to mechanoreceptors in the foot;

at least one bias signal generator adapted to provide a driving signal to drive the at least one bias signal inputting means;

a controller means for controlling the at least one bias signal generator and the at least one bias signal inputting means; and

a power source providing electrical energy to the controller means and the at least one bias signal generator.

2. The wearable system of claim 1, wherein the platform is a removable insole insert of a shoe.

3. The wearable system of claim 1, wherein the platform is a shoe.

4. The wearable system of claim 1, wherein the platform is a sock.

5. The wearable system of claim 1, wherein the at least one bias signal input means is positioned such that stimulation is applied to the sides of the foot.

6. The wearable system of claim 1, wherein the at least one bias signal input means is positioned such that stimulation is applied to the plantar surface of the foot.

7. The wearable system of claim 1, wherein the at least one bias signal input means is positioned such that stimulation is applied to the top surface of the foot.

8. The wearable system of claim 1, wherein the at least one bias signal input means is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

9. The wearable system of claim 1, wherein the at least one bias signal input means is positioned on the platform to contact non-pressure point areas of the foot, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

10. The wearable system of claim 1, wherein the at least one bias signal inputting means comprises at least one electrode placed on or near the foot that provides electrical stimulation to the mechanoreceptors of the foot.

11. The wearable system of claim 10, wherein the at least one bias signal inputting means further comprises at least one reference electrode placed on the body wearing the system.

12. The wearable system of claim 1, wherein the at least one bias signal inputting means comprises at least one of a stick-slip electrode, a disposable electrode, and a reusable electrode.

13. The wearable system of claim 12, wherein the stick-slip electrode system comprises an electrode pad incorporated in a garment, a hydrophilic and lubricious coating, a conductive hydrogel skin mount, and an adhesive layer.

14. The wearable system of claim 13, wherein the electrode pad incorporated in a garment is oversized relative to the other components of the electrode.

15. The wearable system of claim 8, wherein the platform is a flexible disposable pad having a form of a foot with an underside coated with adhesive for removably attaching to an insole of a shoe.

16. The wearable system of claim 11, wherein the platform comprises an insole portion integrally attached to the bottom of a sock portion.

17. The wearable system of claim 11, wherein the platform is a sock which has integral to it woven electrical conductors as electrodes for applying stimulation.

18. The wearable system of claim 11, wherein the platform is a sock which has integral to it electrode pads for applying stimulation.

19. The wearable system of claim 1, wherein the at least one bias signal inputting means is a vibrational actuator providing stimulating vibration to the mechanoreceptors of the foot.

20. The wearable system of claim 19, wherein the vibrational actuator is an active vibrational actuator.

21. The wearable system of claim 20, wherein the active vibrational actuator comprises at least one of an electromagnetic actuator, an electromechanical actuator, a solid-state actuator, a hydraulic actuator, a pneumatic actuator, a ferro-fluidic actuator, and an electroactive polymeric actuator.

22. The wearable system of claim 21, wherein the at least one electromagnetic actuator comprises at least one of a rotary motor and a linear motor.

23. The wearable system of claim 21, wherein the at least one solid-state actuator comprises at least one of a shape memory alloy, piezoelectric materials, and microelectromechanical actuator.

24. The wearable system of claim 19, wherein the vibrational actuator is a passive vibrational mechanical actuator.

25. The wearable system of claim 24, wherein the passive vibrational actuator comprises at least one of ratcheting system and hook-and-eye filaments.

26. The wearable system of claim 1, wherein the at least one bias signal inputting means comprises a combination of at least one vibrational actuator and at least one electrode pair for a delivery of mechanical and electrical stimulation to the mechanoreceptors of the foot.

27. The wearable system of claim 19, wherein the platform is an insole portion integrally attached to the bottom of a sock portion.

28. The wearable system of claim 19, wherein the platform is a flexible disposable pad having a form of a foot with an underside coated with adhesive for removably attaching to a sole of a shoe.

29. The wearable system of claim 19, wherein the platform comprises a flexible matrix material enclosing a vibration transmitting structure and at least one of the actuators, and the platform is optimized for transmitting vibration to surfaces of the foot.

30. The wearable system of claim 29, wherein the vibration transmitting material comprises rigid beads.

31. The wearable system of claim 29, wherein the vibration transmitting material comprises at least one of polymeric gel and a viscoelastic foam.

32. The wearable system of claim 29, wherein the vibration transmitting material comprises a metallic structural element.

33. The wearable system of claim 29, wherein the vibration transmitting material comprises a composite structural element.

34. The wearable system of claim 29, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, viscoelastic foam, a metallic structural element, and a composite structural element.

35. The wearable system of claim 29, wherein the at least one actuator is encapsulated within the flexible matrix material such that the matrix is optimized for transmitting vibration to the surface of the foot.

36. The wearable system of claim 29, wherein the at least one actuator is disposed outside the flexible matrix material such that the matrix is optimized for transmitting vibration to the surface of the foot.

37. The wearable system of claim 29, wherein the flexible matrix material has a form factor of a shoe insert.

38. The wearable system of claim 19, wherein the removable insole insert comprises a flexible matrix material filled with rigid beads, wherein the at least one bias signal input means comprises a plurality of actuators disposed underneath the insole such that the insole is optimized for transmitting vibration to the plantar surface of the foot.

39. The wearable system of claim 19, wherein the removable insole insert comprises a flexible matrix material filled with rigid beads, and the at least one bias signal input means comprises a plurality of actuators embedded within the flexible matrix material such that the insole is optimized for transmitting vibration to the plantar surface of the foot.

40. The wearable system of claim 19, wherein the at least one bias signal input means comprises one or more actuators positioned such that stimulation is applied to the sides of the foot.

41. The wearable system of claim 19, wherein the at least one bias signal input means comprises at least one actuator positioned such that stimulation is applied to the plantar surface of the foot.

42. The wearable system of claim 19, wherein the at least one bias signal input means comprises at least one actuator positioned such that stimulation is applied to the top surface of the foot.

43. The wearable system of claim 19, wherein the at least one bias signal input means comprises one or more actuator such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

44. The wearable system of claim 19, wherein the at least one bias signal input means comprises one or more actuator positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

45. The wearable system of claim 26, wherein the at least one bias signal input means is applied to the sides of the foot.

46. The wearable system of claim 26, wherein the at least one bias signal input means is positioned such that stimulation is applied to the plantar surface of the foot.

47. The wearable system of claim 26, wherein the at least one bias signal input means is positioned such that stimulation is applied to the top surface of the foot.

48. The wearable system of claim 26, wherein the at least one bias signal input means is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

49. The wearable system of claim 26, wherein the at least one bias signal input means is positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

50. The wearable system of claim 10, wherein the at least one bias signal input means is positioned such that stimulation is applied to the sides of the foot.

51. The wearable system of claim 10, wherein the at least one bias signal input means is positioned such that stimulation is applied to the plantar surface of the foot.

52. The wearable system of claim 10, wherein the at least one bias signal input means is positioned such that stimulation is applied to the top surface of the foot.

53. The wearable system of claim 10, wherein the at least one bias signal input means is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

54. The wearable system of claim 10, wherein the at least one bias signal input means is positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

55. The wearable system of claim 1, wherein the power source, the controller, and signal generator are integrated into a housing that is positioned remotely from the platform and is coupled to the platform.

56. The wearable system of claim 55, wherein the housing is flexible and securable around an ankle.

57. The wearable system of claim 55, wherein the housing is securable onto a shoe.

58. The wearable system of claim 55, where the housing can be secured to a garment.

59. The wearable system of claim 1, wherein the power source, the controller, and signal generator are integrated into the platform.

60. The wearable system of claim 55, wherein the platform further comprises a platform coupling means, a platform power source means for supplying electrical power to the platform coupling means and the at least one bias signal inputting means, and the controller further comprises a controller coupling means for coupling with the platform coupling means for transmitting the driving signal to the platform coupling means.

61. The wearable system of claim 60, wherein the platform coupling means and the controller coupling means are wireless communication means, comprising optical means, RF means, and induction means, or wired serial or parallel communciaton means.

62. The wearable system of claim 19, wherein the at least one bias signal inputting means comprise a plurality of vibrational actuators disposed on the platform at a predetermined spatial separation between the plurality of actuators to induce random vibration by manipulating the phase of the driving signal of each vibrational actuator.

63. The wearable system of claim 19, wherein the at least one bias signal inputting means comprise a plurality of vibrational actuators adapted to create a vibration when being electrically biased, and wherein the controller means is adapted to operate the plurality of vibrational actuators in reverse of others so as to induce random vibrational stimulation.

64. The wearable system of claim 19, wherein the at least one bias signal inputting means comprise a plurality of vibrational actuators adapted to create a vibration when being electrically biased, and wherein the at least one bias signal generator is adapted to generate stepped driving signals, wherein the duration of each step of the driving signals is of a time duration sufficient to avoid placing the actuators in its natural frequency of vibration.

65. The wearable system of claim 61, wherein the time duration is in a range of 2 to 8 msec.

66. The wearable system of claim 19, wherein the at least one bias signal inputting means comprise a plurality of actuators adapted to create a vibration when being electrically biased, and wherein the at least one bias signal generator is adapted to generate an offset driving signal in addition to the driving signal so as to place the actuators in an inertia-overcoming state to improve the time responses of the actuators.

67. The wearable system of claim 63, wherein the at least one bias signal generator is adapted to generate an offset driving signal in addition to the driving signal so as to place the actuators in an inertia-overcoming state to improve the time responses of the actuators when the actuators are being driven in reverse polarity of the others.

68. The wearable system of claim 62 wherein the actuators are electromagnetic motors.

69. The wearable system of claim 63 wherein the actuators are electromagnetic motors.

70. The wearable system of claim 65 wherein the actuators are electromagnetic motors.

71. The wearable system of claim 66 wherein the actuators are electromagnetic motors.

72. The wearable system of claim 68 wherein the actuators are electromagnetic motors.

73. The wearable system of claim 1, wherein the at least one bias signal inputting means comprise a plurality of vibrational actuators disposed on the platform at a predetermined spatial separation between the plurality of actuators to induce a vibration having a desirable amplitude by manipulating phase and amplitude of the driving signal of each vibrational actuator.

74. The wearable system of claim 29, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, a viscoelastic foam, a metallic structural element, and a composite structural element and is arranged in such a way as to effect adjustable vibration propagation.

75. The wearable system of claim 29, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, a viscoelastic foam, a metallic structural element, and a composite structural element and is arranged in such a way as to effect adjustable vibration propagation, and the at least one actuator is a plurality of actuators positioned at a predetermined spatial separation between the plurality of actuators to optimize the vibration propagation characteristics of the platform.

76. The wearable system of claim 1, wherein at least one bias signal generator is programmable and comprises at least one of a predetermined algorithm, a noise generator, and a look-up table for generating a bias signal.

77. The wearable system of claim 76, wherein the noise generator comprises at least one of thermal noise source, and diode noise source.

78. The wearable system of claim 76, wherein the signal generator provides a non-deterministic random signal driving the at least one bias signal input means.

79. The wearable system of claim 76, wherein the signal generator provides a signal of a predetermined at least one repetitive pattern and series of patterns.

80. The wearable system of claim 76, wherein the signal generator provides a signal of controllable signal amplitude, frequency content, waveform shape, and repetition.

81. The wearable system of claim 76, wherein the controller is adapted to control each individual bias signal inputting means so as to effect individually controllable amplitude, frequency content, waveform shape, and repetition of the bias signal.

82. The wearable system of claim 76, wherein the controller means controls the at least one bias signal generator and at least one bias signal input means to operate at a sub-threshold level so as to effect sensory enhancement.

83. The wearable system of claim 76, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate at a supra-threshold level so as to effect therapeutic massage and improvement of blood flow.

84. The wearable system of claim 76, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate alternately at a sub-threshold level and a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

85. The wearable system of claim 76, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means, and the at least one bias signal input comprises at least two bias signal input means, one operating at a sub-threshold level and alternately with another one operating at a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

86. The wearable system of claim 10, wherein the bias signal for driving the at least one electrode is composed of one or more frequencies with a bandwidth of greater than 0 Hz to about 10 KHz.

87. The wearable system of claim 86, wherein the bias signal for driving the at least one electrode pair is composed of one or more frequencies with a bandwidth of preferably greater than 0 Hz to about 5 KHz.

88. The wearable system of claim 87, wherein the bias signal for driving the at least one electrode is composed of one or more frequencies with a bandwidth of most preferably of greater than 0 Hz to about 1 KHz.

89. The wearable system of claim 10, wherein the bias signal for driving the at least one electrode is composed of a current in a range of between 0 to 10 mA/in².

90. The wearable system of claim 89, wherein the bias signal for driving the at least one electrode is composed of a current in a range of preferably between 0 to 1 mA/in².

91. The wearable system of claim 90, wherein the bias signal for driving the at least one electrode is composed of a current in a range of most preferably between 0 to 0.5 mA/in².

92. The wearable system of claim 19, wherein the bias signal for driving the vibrational actuator is composed of one or more frequencies with a bandwidth of greater than 0 Hz to about 1 KHz.

93. The wearable system of claim 92, wherein the bias signal for driving the vibrational actuator is composed of one or more frequencies with a bandwidth more preferably of greater than 0 Hz to about 500 Hz.

94. The wearable system of claim 93, wherein the bias signal for driving the vibrational actuator is composed of one or more frequencies with a bandwidth most preferably of greater than 0 Hz to about 100 Hz.

95. The wearable system of claim 19, wherein the bias signal for driving the vibrational actuator is composed of a mechanical stimulation of greater than 0 lbs/in² to about 10 lbs/in².

96. The wearable system of claim 95, wherein the bias signal for driving the vibrational actuator is composed of a mechanical stimulation of more preferably greater than 0 lbs/in² to about 5 lbs/in².

97. The wearable system of claim 96, wherein the bias signal for driving the vibrational actuator is composed of a mechanical stimulation of greater than 0 lbs/in² to about 11b/in².

98. The wearable system of claim 1, wherein the controller means is adapted to detect a stance phase and a swing phase, and to provide sub-threshold stimulation for sensory enhancement during a stance phase and to provide supra-threshold stimulation for improving blood flow during a swing phase.

99. The wearable system of claim 1, wherein the controller means comprises means for detecting pressure exerted on the platform so as to detect to what degree the foot is bearing weight.

100. The wearable system of claim 99, wherein the controller means further comprises power management means for placing the system in a power conservation mode when the foot is not substantially bearing weight.

101. The wearable system of claim 1, wherein the platform comprises means for detecting pressure exerted on the platform so as to detect what degree the foot is bearing weight.

102. The wearable system of claim 1, wherein the controller means comprises means for determining gait cycles so as to place the system under a power conservation mode during predetermined phases of a predetermined gait cycle.

103. The wearable system of claim 1, further comprising a power recovery means for harnessing energy from gait cycles and means for recharging the power source from the harnessed energy.

104. The wearable system of claim 103, wherein the power recovery means comprises converting means for converting mechanical energy into electrical energy.

105. The wearable system of claim 104, wherein the converting means comprises at least one of a piezo-electric means, a linear electromechanical generator means, hydraulic generator means, and a electro-active polymer means.

106. The wearable system of claim 1, wherein the controller means further controls the power source to switch the power source on and off and to an activate power conservation mode based the detection of motion of the wearable system.

107. The wearable system of claim 1, wherein the power source comprises a recharging means.

108. The wearable system of claim 107, wherein the recharging means is an inductive coupling.

109. The wearable system of claim 107, wherein the recharging means is a electrical socket for receiving an electrical connector providing electrical energy to recharge the power source.

110. The wearable system of claim 1, wherein the power source is at least one of a rechargeable lithium-ion battery, polymer battery, gel battery, and nickel metal hydride.

111. The wearable system of claim 110, wherein the power source is removably disposed in the sole of a shoe.

112. The wearable system of claim 110, wherein the power source is located separately from the platform.

113. The wearable system of claim 1, wherein the power source, the bias signal generator, and the controller means are disposed in the sole of the shoe.

114. The wearable system of claim 2, wherein the power source, the at least one bias signal generator, and the control means are disposed on the removable insole insert.

115. The wearable system of claim 1, further comprising a thermal radiation source controlled by the control means for providing heating to the foot.

116. The wearable system of claim 115, wherein the thermal radiation source is an infrared light source.

117. The wearable system of claim 115, wherein the thermal radiation source is a heating filament.

118. The wearable system of claim 1, further comprising adjusting means for a wearer to adjust the amplitude of the bias signal, including threshold and therapeutic levels of one or more of the inputting means.

119. The wearable system of claim 1, further comprising external power coupling means for recharging the power source, interface means for interfacing the control means with an external device for diagnostic, optimization, calibrating and programming the wearable system and recharging the power source.

120. A wearable system for neurological stimulation of a human ankle, the system comprising:

a platform having at least one bias signal inputting means adapted to apply a stimulation to mechanoreceptors in the ankle;

at least one bias signal generator adapted to provide a driving signal to drive the at least one bias signal inputting means;

a controller means for controlling the at least one bias signal generator and the at least one bias signal inputting means; and

a power source providing electrical energy to the controller means and the at least one bias signal generator.

121. The wearable system of claim 120, wherein the platform is an ankle wrap.

122. The wearable system of claim 120, wherein the platform is a boot.

123. The wearable system of claim 120, wherein the platform is a sock.

124. The wearable system of claim 120, wherein the platform is a customized structure adapted to position a bias signal inputting means in apposition to specific anatomical structures of the ankle.

125. The wearable system of claim 120, wherein the at least one bias signal input means is positioned such that the stimulation is applied either singly or collectively to the ligaments, tendons, or muscles associated with the ankle.

126. The wearable system of claim 120, wherein the at least one bias signal input means is positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to a patient wearing the platform, and to contact non-bending areas of the ankle, so as to allow the flexing of the platform during ankle movement without additional or uncomfortable stress being placed on the ankle.

127. The wearable system of claim 120, wherein the at least one bias signal inputting means comprises at least one electrode placed on or near the ligaments, tendons, and muscles connected to the ankle that provides electrical stimulation to the mechanoreceptors of the ankle.

128. The wearable system of claim 127, wherein the at least one bias signal inputting means further comprises at least one reference electrode provided on a human body wearing the system.

129. The wearable system of claim 128, wherein the at least one electrode comprises at least one of a stick-slip electrode, a disposable electrode, and a reusable electrode.

130. The wearable system of claim 120, wherein the at least one bias signal inputting means is a vibrational actuator providing stimulating vibration to the mechanoreceptors of the ankle.

131. The wearable system of claim 120, wherein the at least one bias signal inputting means comprises a combination of at least one vibrational actuator and at least one electrode pair for a delivery of mechanical and electrical stimulation to the mechanoreceptors of the ankle.

132. The wearable system of claim 130, wherein the platform comprises a flexible matrix material enclosing a vibration transmitting structure and at least one of the actuators, and the platform is optimized for transmitting vibration to the ankle.

133. The wearable system of claim 120, wherein the power source, the controller, and signal generator are integrated into a housing that is positioned remotely from the platform and is electrically connected to the platform.

134. The wearable system of claim 133, wherein the housing is flexible and securable around an ankle.

135. The wearable system of claim 133, wherein the housing is securable onto a shoe or other garment.

136. The wearable system of claim 120, wherein the power source, the controller, and signal generator are integrated into the platform.

137. The wearable system of claim 120, wherein the at least one bias signal generator is programmable comprises at least one of a predetermined algorithm, a noise generator, and a look-up table for generating a bias signal.

138. The wearable system of claim 137, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate at a sub-threshold level so as to effect sensory enhancement.

139. The wearable system of claim 137, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate at a supra-threshold level so as to effect therapeutic massage and improvement of blood flow.

140. The wearable system of claim 137, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate alternately at a sub-threshold level and a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

141. The wearable system of claim 137, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means, and the at least one bias signal input comprises at least two bias signal input means, one operating at a sub-threshold level and alternately with another one operating at a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

142. The wearable system of claim 120, wherein the controller means is adapted to detect a stance phase and a swing phase, and to provide sub-threshold stimulation for sensory enhancement during a stance phase and to provide supra-threshold stimulation for improving blood flow during a swing phase.

143. The wearable system of claim 120, wherein the controller means comprises means for detecting motion of the ankle.

144. The wearable system of claim 143, wherein the controller means further comprises power management means for placing the system under in a power conservation mode when the ankle is not in motion.

145. The wearable system of claim 120, wherein the controller means comprises means for determining gait cycles so as to place the system under a power conservation mode during a predetermined gait cycle.

146. The wearable system of claim 120, further comprising:

a power recovery means for harnessing energy from gait cycles and means for recharging the power source from the harnessed energy.

147. The wearable system of claim 120, wherein the power source comprises a recharging means.

148. The wearable system of claim 120, wherein the power source is located separately from the platform.

149. The wearable system of claim 120, wherein the power source, the bias signal generator, and the controller means are disposed in the sole of the shoe.

150. The wearable system of claim 120, further comprising adjusting means for a wearer to adjust the amplitude of the bias signal, including threshold and therapeutic levels.

151. The wearable system of claim 150, further comprising external power coupling means for recharging the power source, interface means for interfacing the control means with an external device for diagnostic, optimization, calibrating and programming the wearable system and recharging the power source.

152. A wearable system for neurological stimulation of a human foot and ankle, the system comprising:

a platform having at least one bias signal inputting means adapted to apply a stimulation to mechanoreceptors in the foot and ankle;

at least one bias signal generator adapted to provide a driving signal to drive the at least one bias signal inputting means;

a controller means for controlling the at least one bias signal generator and the at least one bias signal inputting means; and

a power source providing electrical energy to the controller means and the at least one bias signal generator.

153. The wearable system of claim 152, wherein the platform is a removable insole insert of a shoe.

154. The wearable system of claim 152, wherein the platform is a boot.

155. The wearable system of claim 152, wherein the platform is a sock.

156. The wearable system of claim 152, wherein the platform is a customized structure adapted to position a bias signal inputting means in apposition to specific anatomical structures of the foot and ankle.

157. The wearable system of claim 152, wherein the at least one bias signal input means is positioned such that the stimulation is applied to at least one surface of the foot and to the ligaments, tendons, or muscles associated with the ankle.

158. The wearable system of claim 152, wherein the at least one bias signal inputting means comprises at least one electrode that provides electrical stimulation to the mechanoreceptors of the foot and ankle.

159. The wearable system of claim 158, wherein the at least one bias signal inputting means further comprises at least one reference electrode provided on a human body wearing the system.

160. The wearable system of claim 152, wherein the at least one bias signal inputting means is a vibrational actuator providing stimulating vibration to the mechanoreceptors of the foot and ankle 520. The wearable system of claim 501, wherein the at least one bias signal inputting means comprises a combination of at least one vibrational actuator and at least one electrode pair for a delivery of mechanical and electrical stimulation to the mechanoreceptors of the foot and ankle.

161. The wearable system of claim 152, wherein the platform comprises a flexible matrix material enclosing a vibration transmitting material and at least one of the actuators, and the platform is optimized for transmitting vibration to surfaces of the foot and to the ankle.

162. The wearable system of claim 160, wherein the power source, the controller, and signal generator are integrated into a housing that is positioned remotely from the platform and is electrically connected to the platform.

163. The wearable system of claim 152, wherein the power source, the controller, and signal generator are integrated into the platform.

164. The wearable system of claim 152, wherein the at least one bias signal generator is programmable comprises at least one of a predetermined algorithm, a noise generator, and a look-up table for generating a bias signal.

165. The wearable system of claim 164, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate at a sub-threshold level so as to effect sensory enhancement.

166. The wearable system of claim 164, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate at a supra-threshold level so as to effect therapeutic massage and improvement of blood flow.

167. The wearable system of claim 164, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means to operate alternately at a sub-threshold level and a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

168. The wearable system of claim 164, wherein the controller means controls the at least one bias signal generator and the at least one bias signal input means, and the at least one bias signal input comprises at least two bias signal input means, one operating at a sub-threshold level and alternately with another one operating at a supra-threshold level, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

169. The wearable system of claim 152, wherein the controller means is adapted to detect a stance phase and a swing phase, and to provide sub-threshold stimulation for sensory enhancement during a stance phase and to provide supra-threshold stimulation for improving blood flow during a swing phase.

170. The wearable system of claim 152, wherein the controller means comprises means for detecting pressure exerted on, or motion of, the platform

171. The wearable system of claim 170, wherein the controller means further comprises power management means for placing the system under in a power conservation.

172. The wearable system of claim 152, wherein the controller means comprises means for determining gait cycles so as to place the system under a power conservation mode during a predetermined gait cycle.

173. The wearable system of claim 152, further comprising:

a power recovery means for harnessing energy from gait cycles and means for recharging the power source from the harnessed energy.

174. The wearable system of claim 152, wherein the controller means further control the power source to switch the power source on and off and to an activate power conservation mode based the detection of motion of the wearable system.

175. The wearable system of claim 152, wherein the power source comprises a recharging means.

176. The wearable system of claim 152, wherein the power source is located separately from the platform.

177. The wearable system of claim 152, wherein the power source, the bias signal generator, and the controller means are disposed in the sole of the shoe.

178. The wearable system of claim 152, further comprising adjusting means for a wearer to adjust the amplitude of the bias signal, including threshold and therapeutic levels.

179. The wearable system of claim 152, further comprising external power coupling means for recharging the power source, interface means for interfacing the control means with an external device for diagnostic, optimization, calibrating and programming the wearable system and recharging the power source.

180. A system for optimizing neurological stimulation, comprising:

a platform having at least one bias signal inputting means adapted to apply a stimulation to a skin surface area of a test subject;

at least one bias signal generator adapted to provide a driving signal to drive the at least one bias signal inputting means;

a controller means for controlling the at least one bias signal generator and the at least one bias signal inputting means;

a remote external computer for effecting the control of the controller means during an optimization procedure;

a communication means between the remote external computer and the controller; and

a measurement means for measuring the responses of the test subject as stimulation is adjusted,

wherein the remote external computer is adapted to communicate with the controller to effect varying bias signals inputted into the at least one bias signal inputting means, while responses from a subject in contact with the platform and executing a prescribed task are observed and measured,

wherein the remote computer is adapted to determine the optimal bias signal parameters suitable for the subject based on the observed responses of the subject.

181. The system of claim 180, wherein the remote external computer communicates optimal bias signal parameters to a wearable system for neurological stimulation.

182. The system of claim 180, wherein the remote external computer selects bias signal parameters to test based on responses of the subject.

183. The system of claim 180, wherein the platform comprises means to provide test stimuli as well as a bias signal to the subject.

184. The system of claim 180, wherein the remote external computer comprises means for receiving and recording responses from the subject for each bias signal applied.

185. The system of claim 183, wherein the remote external computer comprises means for receiving and recording responses from the subject for each bias signal used and each test stimulus applied.

186. The system of claim 180, wherein the remote external computer is adapted to communicate with the controller means to effect the generation of a bias signal of a predetermined one or more frequencies, amplitude, repetition, waveform shape, and pattern.

187. The system of claim 180, wherein the communication means is comprised of at least one of a wired or optical serial communication link, a wired or optical parallel communication link, a wireless RF communication link, and a wireless optical communication link.

188. The system of claim 184, wherein the means for receiving subject responses is a wired means.

189. The system of claim 184, wherein the means for receiving subject responses is a wireless means.

190. The system of claim 184, wherein the remote computer is adapted to communicate with the controller to generate a test stimulation directed at a specific actuator and hence a specific region so as to observe and measure localized responses, whereby the response of the subject is recorded and adjustments in stimulation can be made to optimize performance.

191. The system of claim 184, wherein the remote computer is adapted to measure responses from the subject performing a prescribed task demonstrating balance or gait.

192. A method for providing neurological stimulation in a wearable system, comprising:

providing a wearable platform having one or more sources of stimulation, at least one signal generator coupled to the one or more sources of stimulation, a controller for controlling the signal generator, and a power supply source for powering the controller;

selecting a level or form of stimulation; and

activating the signal generator and supplying a bias signal to the one or more sources of stimulation to stimulate mechanoreceptors based on a determined therapeutic need of an individual.

193. The method according to claim 192, wherein selecting a level or form of stimulation comprises first measuring an individual'"'"'s threshold level of sensation in the area to receive stimulation.

194. The method according to claim 192, wherein selecting a level or form of stimulation comprises adjusting or programming the controller to control the bias signal generator to produce a therapeutic level relative to the measured threshold level and according to a therapeutic need of an individual.

195. The method according to claim 194, wherein adjusting or programming the controller to control the bias signal generator to produce a sensory enhancement bias signal comprises setting the bias signal to a subthreshold level.

196. The method according to claim 195, wherein the subthreshold level is about 5 to 50% below the measured threshold level, with a preference of between 10 and 30% below the measured threshold level.

197. The method according to claim 194, further comprising adjusting or programming the controller to control the bias signal generator to produce a suprathreshold level bias signal for the purposes of therapeutic massaging and improving blood flow.

198. The method according to claim 197, wherein setting the inputting bias signal to suprathreshold level comprises setting the input bias signal of 10% to 1000%, preferably 20% to 500%, more preferably 20% to 100% above the determined sensory threshold.

199. The method according to claim 193, wherein the measuring of a threshold level comprises inputting a minimal bias signal to the one or more actuators and progressively increasing the amplitude of the bias signal until an individual wearing the platform detects stimulations from the one or more of the actuators.

200. The method according to claim 193, wherein the measuring of a threshold level comprises inputting a maximal bias signal to the one or more actuators and progressively decreasing the amplitude of the bias signal until an individual wearing the platform no longer detects stimulations from the one or more of the actuators.

201. The method according to claim 193, wherein the measuring of a threshold level comprises a tracking procedure which begins with a minimal or maximal signal and makes incremental changes towards the final threshold based on an individual'"'"'s response.

202. The method according to claim 193, wherein the measuring of a threshold level comprises monitoring activity of sensory neurons emanating from the test area.

203. The method according to claim 193, wherein the measuring of threshold comprises monitoring brain function using tools such as EEG, fMRI, etc.

204. The method according to claim 192, wherein selecting a level or form of stimulation comprises first determining an optimal level of stimulation.

205. The method according to claim 192, wherein selecting a level or form of stimulation comprises adjusting or programming the controller to control the bias signal generator to produce a therapeutic level relative to the optimal level of stimulation.

206. The method according to claim 204 wherein selecting a level or form of stimulation comprises repeatedly measuring the performance of an individual in a directed sensory or sensorimotor task (e.g. tactile sensitivity, standing balance, walking, etc.) and selecting the stimulation so as to optimize the measured performance.

207. The method according to claim 204, wherein the determination of an optimal stimulation level comprises monitoring activity of sensory neurons emanating from the test area.

208. The method according to claim 204, wherein the determination of an optimal stimulation level comprises monitoring brain function using tools such as EEG and fMRI.

209. The method according to claim 192, wherein the inputting the bias signal comprises providing non-deterministically random bias signal.

210. The method according to claim 192, wherein the inputting the bias signal comprises providing a repetitive pattern of bias signal or series of signals.

211. The method according to claim 192, wherein programming the controller comprises programming the bias signal generator to produce a bias signal composed of one or more frequencies within the range of greater than 0 Hz to about 10 KHz, preferably greater than 0 Hz to 5 KHz, more preferably greater than 0 Hz to about 1 KHz for electrical stimulation, and a current in a range of greater than 0 to about 10 mA/in², preferably greater than 0 to about 1 mA/in², more preferably greater than 0 mA/in² to about 0.5 1 mA/in² for electrical stimulation.

212. The method according to claim 192, wherein the bias signal is in a range of greater than 0 Hz to about 1 KHz, preferably greater than 0 Hz to about 500 Hz, more preferably greater than 0 Hz to about 100 Hz for mechanical stimulation, and in a range of greater than 0 lbs/in² to about 10 lbs/in², preferably greater than 0 lbs/in² to about 5 lbs/in , more preferably greater than 0 lbs/in² to about 1 lbs/in² as a mechanical stimulus.

213. The method of claim 192, wherein programming the controller further comprises adapting the controller means to activate a power conservation mode during a predetermined gait cycle.

214. The method of claim 192, wherein programming the controller further comprises adapting the controller means to alternately provide subthreshold stimulation for sensory enhancement and suprathreshold stimulation for improving blood flow.

215. The method of claim 192, wherein programming the controller further comprises adapting the controller means to detect a stance phase and a swing phase, and providing a subthreshold stimulation for sensory enhancement during a stance phase and a suprathreshold stimulation for improving blood flow during a swing phase.