Comparing Active and Passive Ankle-foot Prostheses

Trans-tibial Amputation Clinical Trial

Official title:

Comparing Active and Passive Ankle-foot Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684501
• Other study ID #: 2010-P-000951
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: April 10, 2017
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2017
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Trans-tibial Amputation

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle power generation	Ankle power derived using a camera-based motion capture system during walking	During the session trial (approx 10 minutes)
Secondary	Metabolic cost of ambulation	Oxygen consumption during level-ground walking	During the session trial (approx 10 minutes)