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Determining the Potential Benefit of Powered Prostheses

NCT02828982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-01-18

Study results available
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Summary

The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.

Conditions

  • Unilateral Traumatic Amputation
  • Amputation, Traumatic

Interventions

DEVICE

Powered ankle prosthesis

This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.

DEVICE

Dynamic Response Foot

This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.

Sponsors & Collaborators

  • Deanna H Gates

    lead OTHER

Principal Investigators

  • Deanna H Gates, Ph.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828982 on ClinicalTrials.gov