Clinical Trial: Determining the Potential Benefit of Powered Prostheses

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Determining the Potential Benefit of Powered Prostheses

Brief 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.

Detailed Summary: Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.
Sponsor: Deanna Gates

Current Primary Outcome:

  • Change from unpowered prosthesis (baseline) in energetic cost of walking [ Time Frame: 2 weeks ]
    Energetic costs will be measured using a portable metabolic system when participants walk with an unpowered prosthesis and then in a powered prosthesis after two weeks of use.
  • Change from unpowered prosthesis (baseline) in the amount of activity performed outside the home over a two week period [ Time Frame: 2 weeks ]
    Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period.
  • Change from unpowered prosthesis (baseline) in Quality of life (QoL) on a Short-Form 36 after two weeks of wearing a powered device [ Time Frame: 2 weeks ]
    Participants will complete the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) at baseline and then after two weeks of using the BiOM prosthesis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from unpowered prosthesis (baseline) in the Prosthetic Evaluation Questionnaire (PEQ) after two weeks of wearing a powered device [ Time Frame: 2 weeks ]
    Participants will complete a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after two weeks of use.
  • Change from unpowered prosthesis (baseline) in muscle activity after two weeks of wearing a powered device [ Time Frame: 2 weeks ]
    Participants will walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. They will complete this testing both in the unpowered prosthesis and in the powered prosthesis after 2 weeks of use
  • Change from unpowered prosthesis (baseline) in time to fatigue after two weeks of wearing a powered device [ Time Frame: 2 weeks ]
    Participants will walk on a treadmill until they feel they can no longer continue. The time to fatigue will be recorded. Participants will complete this testing both in the unpowered prosthesis and in the powered prosthesis after 2 weeks of use


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: June 29, 2016
Date Started: July 2016
Date Completion: September 2017
Last Updated: July 19, 2016
Last Verified: July 2016