Powered ankle prosthesis with neural control and skin feedback for people with lower-leg amputation
Official title: Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks
Run by Massachusetts Institute of Technology · NCT07645729 · Data updated 2026-11-12
A powered ankle prosthesis that uses neural signals and skin stimulation to help people with a transtibial amputation walk more naturally.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | September 30, 2030 |
| Study ends | September 30, 2031 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07645729 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with unilateral transtibial amputation who can walk with a K3 or higher functional level and have adequate socket fit.
✕Probably not a fit
Individuals with pregnancy, severe comorbidities, extreme obesity (BMI > 40), or conditions limiting participation may see little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests a bidirectionally controlled powered ankle prosthesis in people with unilateral transtibial amputation and compares performance with their prescribed prosthesis and with non-amputee controls. It uses implanted or non-implanted electrode configurations to drive the device and deliver cutaneous feedback, while collecting gait and sensor data during free-space movements and walking tasks. The study has three cohorts: with osseointegrated electrodes, without implanted electrodes, and healthy controls, to assess embodiment, gait symmetry, and stability. Control settings may be adjusted during sessions, and outcomes are compared to baseline prosthesis use to guide future bionic ankle development.
Why it matters
Potential benefit: If successful, the prosthesis could improve embodiment, gait quality, and daily function for people with lower-extremity amputation.
How similar studies have gone: Prior work in neuroprosthetics and biofeedback has shown promise in improving control and embodiment for limb prostheses, but this specific bidirectional neural–cutaneous approach is at the frontier.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female age 18-70. The patient must have a unilateral transtibial amputation . The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above). The patient must have adequate socket to support the device. Exclusion Criteria: * Women who are pregnant. Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \>40, etc.).
Where it's running
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MIT Media Lab
Cambridge, Massachusetts, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.