Comparing Active and Passive Ankle-foot Prostheses

Completed

Conditions studied: Trans-tibial Amputation

In brief

The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Key facts

Study ID

NCT01684501

Run by

Spaulding Rehabilitation Hospital

People needed

6

Starts

2010-05-01

Expected to finish

2013-03-01

Last updated by the study team

2017-04-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• weigh more than 200 lbs
• are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
• have the ability to follow multi-step commands.

You may not qualify if…

• score level D on the SIGAM mobility grade
• have experienced 1 or more falls in the last month before the study
• have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
• the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
• the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
• Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

Where it is running

• Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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