Skip to main content
Clinical Trials/NCT02828982
NCT02828982
Completed
N/A

Determining the Potential Benefit of Powered Prostheses

Deanna H Gates1 site in 1 country12 target enrollmentJuly 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Unilateral Traumatic Amputation
Sponsor
Deanna H Gates
Enrollment
12
Locations
1
Primary Endpoint
Metabolic Cost of Walking
Status
Completed
Last Updated
4 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
August 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Deanna H Gates
Responsible Party
Sponsor Investigator
Principal Investigator

Deanna H Gates

Assistant Professor

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Metabolic Cost of Walking

Time Frame: Testing took place after wearing the prostheses for two weeks

Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.

Total Steps 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. Daily step count taken outside of the home, determined using an activity monitor and GPS device

Quality of Life (QoL) on a Short-Form 36

Time Frame: Questionnaire completed 2 weeks after wearing each prosthesis

Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

Secondary Outcomes

  • Time to Fatigue(Testing took place after wearing the prostheses for two weeks)
  • Prosthetic Evaluation Questionnaire (PEQ)(Questionnaire completed 2 weeks after wearing each prosthesis)
  • Muscle Activity in the Lower Limb(Testing took place after the participant wore the prosthesis for 2 weeks)

Study Sites (1)

Loading locations...

Similar Trials