Determining the Potential Benefit of Powered Prostheses

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2019

Detailed Description

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.

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.

Arms, Groups and Cohorts

  • Experimental: Powered Ankle Prosthesis
    • In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks.
  • Sham Comparator: Dynamic Response Foot
    • In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes

Exclusion Criteria

  • History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deanna H Gates
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Deanna H Gates, Assistant Professor – University of Michigan
  • Overall Official(s)
    • Deanna H Gates, Ph.D., Principal Investigator, University of Michigan

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