Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in Gait Evaluation between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
Change in 6 minute walk test between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
Change in AmpPro between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
Change in the CHAMP between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
Change from Baseline in Serial Subtraction at Week 4 and Week 8
Timeframe: Baseline, Week 4, and Week 8
Change from Baseline in COWAT at Week 4 and Week 8
Timeframe: Baseline, Week 4, and Week 8
Change from Baseline in Category Test at Week 4 and Week 8
Timeframe: Baseline, Week 4, and Week 8
Change from Baseline in CNS Vital Signs at Week 8
Timeframe: Baseline and Week 8