Comparing Active and Passive Ankle-foot Prostheses

Completed

• Conditions: Trans-tibial Amputation

• Registration Number: NCT01684501
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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).

Detailed Description

Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankle power generation	During the session trial (approx 10 minutes)	Ankle power derived using a camera-based motion capture system during walking

Secondary Outcome Measures

Name	Time	Method
Metabolic cost of ambulation	During the session trial (approx 10 minutes)	Oxygen consumption during level-ground walking

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital Boston; 🇺🇸 Boston, Massachusetts, United States