Neural-controlled powered knee and ankle for people with above-knee amputation.
Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks
We will test whether a neural-controlled powered knee or ankle prosthesis helps people with above-knee (transfemoral) amputation walk more naturally and stably in everyday situations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT07204912 on ClinicalTrials.gov |
What this trial studies
This single-site interventional project will fit participants who have unilateral transfemoral amputation with an MIT Powered Leg that uses neural control and will have them perform a range of real-world mobility tasks. Investigators will compare walking symmetry, stability, and the user's sense of embodiment when using the powered prosthesis versus their prescribed prosthesis, collecting biomechanical and user-reported measures. Participants will be adults aged 18–70 with functional mobility at K3 level or above and an adequate socket to support the device. Results will inform future bionic prosthesis design and integration into daily life.
Who should consider this trial
Good fit: Ideal participants are adults 18–70 with a unilateral transfemoral (above-knee) amputation who can walk at variable cadences (K3 or higher) and have an adequate socket to support the device.
Not a fit: People with bilateral amputations, low functional mobility (below K3), severe comorbidities, atypical skeletal anatomy, BMI over 40, or who are pregnant are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could improve walking symmetry, stability, and the user's sense of limb embodiment, making daily mobility easier and safer.
How similar studies have performed: Previous small-scale and lab-based studies of powered or neurally controlled lower-limb prostheses have shown promising gains in gait and user experience, but real-world data across diverse tasks remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female age 18-70. * The patient must have a unilateral transfemoral 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 this trial is running
Cambridge, Massachusetts
- MIT Media Lab — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hugh Herr — MIT Media Lab
- Study coordinator: John A McCullough, B.S. Mechanical Engineering
- Email: johnmccu@mit.edu
- Phone: 424-603-1074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.