Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT07645729
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Powered Prosthesis — DEVICE
    This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.
  • Prescribed Prosthesis — DEVICE
    Subject's prescribed prosthesis

Study Details

The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.

Key Dates

Start date
Oct 21, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2031

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Powered Prosthesis
    The subject will be provided with a powered ankle prosthesis to attach in place of their customary prosthesis. This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin.
  • Active Comparator: Prescribed Prosthesis
    The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care.

Primary Outcome Measure

Kinematic Measures of Lower-Limb Biomechanics [ Time Frame: Multiple sessions across 1-2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
MIT Media LabCambridgeMassachusetts02139
Christopher Shallal, B.S.
[email protected]
704-904-6112

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By research site
MIT Media Lab· Cambridge, MA

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