The Effect of a Microprocessor Prosthetic Foot on Function and Quality of Life in Transtibial Amputees Who Are Limited Community Ambulators
Technical Report,01 Sep 2018,31 Aug 2019
University of Tennessee Memphis United States
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This project is a 2-arm, parallel, randomized, controlled clinical trial designed to determine if a microprocessor controlled prosthetic footMPF, with greater range of motion and active power, will translate into improved functional performance, ambulatory safety risk of falls and quality of life in trans-tibial amputees TTA who function as limited community ambulators. We will assess these outcomes in 54 veterans with TTA by randomizing participants, in a 11 ratio, into an intervention and a comparison group. Participants in the intervention group will receive an MPF, while the comparison group will continue with their currently prescribed prosthetic foot. All participants will be followed with weekly contact over a 6-month period of time in addition to receiving physical therapy training. All outcome measures will be evaluated three times during the 6-month study period. Once HRPO approval for the project was received in April 2016, recruitment efforts via Partner Prosthetic clinics was undertaken to identify over 700 potentially eligible individuals, 40 of whom were veterans. Similar efforts with the Regional DAV, local area hospitals, and additional prosthetic clinics in the mid-south region have also been undertaken yielding over 2300 additional potentially eligible individuals. Active recruitment began in July 2016 and has yielded 373 individuals responding to recruitment efforts to date, 251 of whom have been screened for eligibility. Of those, 91 36 met eligibility criteria to qualify for evaluation. Forty-two 46.2 of those individuals who comprised 11.3 of the total 373 screened met the K-Level 2-3 classification as a community ambulator and were eligible for randomization to group assignment. Completion of the study recruitment, enrollmentrandomization, intervention and follow-up assessments will be accomplished in the coming quarteryear.
- Medicine and Medical Research