Comparing Active and Passive Ankle-foot Prostheses

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).

Study Overview

• Status: Completed
• Conditions: Trans-tibial Amputation

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Spaulding Rehabilitation Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with history of traumatic unilateral transtibial amputation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Amputees; Adults with history of traumatic unilateral transtibial amputation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic cost of ambulation	Oxygen consumption during level-ground walking	During the session trial (approx 10 minutes)

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Paolo Bonato, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 7, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: gait; prosthesis; amputees
• Other Study ID Numbers: 2010-P-000951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No