ClinicalTrials.gov identifier: NCT02828982
Purpose: 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: Interventional
Study design: Randomized, efficacy study, crossover assignment, open label, supportive care
Estimated enrollment: 12
Eligibility criteria: Both genders eligible; ages 21 years and older. Patients must have unilateral transtibial amputation, have used a prosthesis for at least 6 months and be currently using an unpowered prosthesis. Excludes patients with a history of orthopedic or neurologic disorders to their intact limb, with history of cardiovascular disease that prevents them from safely completing requested activities and who are unable to walk for 30 minutes at a time.
Study start date: July 2016
Estimated study completion date: September 2017
Estimated primary completion date: The final collection date for primary outcome measures will be September 2017.
Primary outcome measures: Change from unpowered prosthesis (baseline) in energetic cost of walking, change from unpowered prosthesis (baseline) in the amount of activity performed outside the home over a 2-week period and change from unpowered prosthesis (baseline) in quality of life on a Short-Form 36, all measured after 2 weeks of wearing a powered device
Secondary outcome measures: Change from unpowered prosthesis (baseline) in the Prosthetic Evaluation Questionnaire, change from unpowered prosthesis (baseline) in muscle activity and change from unpowered prosthesis (baseline) in time to fatigue, all measured after 2 weeks of wearing a powered device
Sponsors and collaborators: Deanna Gates, PhD
Information acquired from: Deanna Gates, University of Michigan, via clinicaltrials.gov
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