Effect of a Powered Ankle Foot Orthosis (PAFO) on Function, Safety, and Quality of Life in Military Service Members and Veterans Who Wear a Prescribed Orthosis
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This project is a 2-arm, parallel, randomized, controlled clinical trial designed to determine if a powered ankle foot orthosis (PAFO), that assists with toe clearance and provides push-off power when taking a step, will translate into enhanced function in individuals who walks with a prescribed AFO. We will assess these outcomes in 64 veterans who walk with a prescribed AFO by randomizing participants, in a 1:1 ratio, into an intervention and a comparison group. Participants in both groups will receive new shoes to be worn with their orthosis to eliminate any confounding variables presented by worn or inadequate shoes. Participants in the intervention group will be fitted with and trained to use a PAFO while the comparison group will continue with their currently prescribed orthosis. All participants will be followed with weekly contact over a 7-month period of time and receive physical therapy training. All outcome measures will be evaluated three times during the 7-month study period. Local IRB approval was received August 2018 and HRPO application was submitted. We are currently awaiting HRPO approval. Recruitment resources via Partner Orthotic clinics, Regional DAV, local area health care agencies and physician practices have been identified and approval to contact potential study volunteers is currently in progress. Recruitment, enrollment/randomization, intervention and follow-up assessments will take place during in the coming quarters/year.
Effect of a Powered Ankle Foot Orthosis (PAFO) on Function, Safety, and Quality of Life in Military Service Members and Veterans Who Wear a Prescribed Orthosis