ClinicalTrials.gov identifier: NCT03204531
Purpose: The overall goal of the study is to determine the efficacy of new, powered prosthetic devices for individuals with transfemoral amputations. The objective of the proposed clinical trial to is evaluate the biomechanical and energetic effects of using powered knee-ankle prosthesis and quality functional performance and quality of life changes.
Study type: Interventional
Study design: The randomized intervention model is an open-label study with the primary purpose of design feasibility. Two experimental comparator arms include the experimental arm, in which upon screening and enrollment, participants will return for up to eight prosthetic fitting sessions and up to 12 physical therapy sessions using the Vanderbilt Powered Knee-Ankle (PKA) prosthesis. Participants will return for up to six post-training assessment sessions using the PKA prosthesis. The active comparator arm will already have their own microprocessor-controlled non-powered knee prostheses per inclusion criteria and will follow the same schedule as the experimental arm.
Estimated enrollment: 15
Eligibility criteria: To be included in this study, participants must between 18 years and 80 years, have unilateral transfemoral-level limb loss or limb difference, K2/K3/K4 level ambulators and be required to use a microprocessor knee on their prosthesis. Exclusion criteria: Participants must not weigh more than 250 pounds or be inactive and physically unfit. They may not have cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments. They may not be pregnant. They may not have a comorbidity that interferes with the study, including stroke, pacemaker placement, sever ischemia or cardiac disease.
Study start date: December 2016
Estimated study completion date: April 2020
Estimated primary completion date: April 2018 (Final data collection date for primary outcome measure)
Primary outcome measures: Changes between devices of the modified graded treadmill test at weeks 6 to 7 (post-training assessments) and weeks 21 to 22 (post-training assessment). Change in biomechanical assessment (gait parameters and surface EMG activation) between devices (time frame: weeks 6 to 7 and weeks 21 to 22).
Secondary outcome measures: Include change in manual muscle test, change in passive range of motion, change in active range of motion, 6-minute walking test with COSMED K4B2 metabolic unit, hill assessment index, stair assessment index, cross walk blinking signal test, GAITRite Data Capture, five times sit to stand test, 4-square step test, talks while walking test, outdoor uneven surfaces test, amputee mobility predictor and mini mental state exam.
Sponsors and collaborators: Shirley Ryan AbilityLab
Contact: Shenan Hoppe-Ludwig, CPO, 312-238-5658, email@example.com; Lori McGee Koch, 312-238-2091; firstname.lastname@example.org.
Information acquired from: Arun Jayaraman, principal investigator, Shirley Ryan AbilityLab
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