10 Participants NeededMy employer runs this trial

Powered Ankle Prosthesis for Amputation

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who have had a below-the-knee amputation on one leg, can walk at different speeds using a prosthesis (K3 level or higher), and have a socket that fits the device.

Inclusion Criteria

I am between 18 and 70 years old.
I can walk at different speeds and use a prosthetic leg at K3 level or higher.
My socket is healthy enough to support the device.
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Exclusion Criteria

I am currently pregnant.
I do not have severe health issues or conditions that would prevent me from joining this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Practice and Adjustment

Participants are given time to practice using the powered ankle prosthesis and adjustments are made to the control settings

As much time as necessary

Experimental Sessions

Participants undergo experiments using both the powered and prescribed prostheses, with data collected from wearable sensors and motion-capture devices

1-2 weeks
Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after the experimental sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Powered Ankle Prosthesis

Trial Overview

The study compares a new powered ankle prosthesis—controlled by nerve signals and skin stimulation—to each participant's usual prosthetic leg. It looks at walking ability, stability, and how natural the device feels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Powered ProsthesisExperimental Treatment1 Intervention
Group II: Prescribed ProsthesisActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials
104
Recruited
12,810,000+