Transfemoral Powered Foot and Physical Therapy Study (NCT03625921) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transfemoral Powered Foot and Physical Therapy Study
United States20 participantsStarted 2017-11-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unilateral TFA, any etiology
* Experienced (\> 6 months) microprocessor knee user
* Less than or equal to 8 amputation related physical therapy sessions in the previous 6 months
* At least 18 y.o.
* High K2 or above ambulator
* Able to walk a minimum of 30 m without an assistive device
* Able to walk on treadmill for 5 minutes at self-selected speed with or without use of handrails
Exclusion Criteria:
* Inability to tolerate wearing of a socket or a poorly fitting socket
* Condition of intact limb prohibits prosthesis use (ulcers, sores, skin breakdown, burns, poor skin coverage, contractures, and severe heterotopic ossification)
* The length of the residual limb prohibits socket/device fitting
* Cognitive deficits or a mental health pathology limiting the ability to participate fully in the study or any deficit deemed by the PI to be detrimental to the completion of the study
* Significant comorbidity, which would interfere with the study (for example: neuropathy, uncontrolled diabetes, receiving dialysis, have insensate feet or severe phantom pain or a history of skin ulcers)
* Severe circulatory problems including peripheral vascular disease and pitting edema
* Pregnant women in the 2nd trimester or beyond or women who will be in the 2nd trimester within the enrollment period. This will be determined by asking the participant if she is pregnant or if they believe they may be pregnant. The question will only be asked at inclusion, as biomechanical c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing people who receive physical therapy alongside a powered prosthetic foot versus those who don't — given my current fitness level and rehab history, which group does my doctor think would be more relevant to my situation?
2The trial is measuring not just walking ability but also cognitive tests like serial subtraction and verbal fluency — can my doctor explain why brain function is being tracked in a prosthetic foot study, and what that might mean for how I'd be evaluated?
3Since this study is active but no longer recruiting new participants, does my doctor know of any similar trials involving powered prosthetic feet and physical therapy that I might still be eligible to join?
4The trial tracks walking endurance with a 6-minute walk test and an obstacle course test called the CHAMP — based on where I am right now, does my doctor think I'd be physically ready to complete those kinds of assessments safely?
5Given that this trial doesn't have a traditional phase number and is focused on comparing rehabilitation approaches rather than testing a new drug, how does my doctor weigh this kind of study against simply starting standard prosthetic training and physical therapy right away?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gait Evaluation between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
2
Change in 6 minute walk test between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
3
Change in AmpPro between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
4
Change in the CHAMP between PT and non-PT groups
Timeframe: Baseline, Week 4, and Week 8
5
Change from Baseline in Serial Subtraction at Week 4 and Week 8
Timeframe: Baseline, Week 4, and Week 8
6
Change from Baseline in COWAT at Week 4 and Week 8
Timeframe: Baseline, Week 4, and Week 8
7
Change from Baseline in Category Test at Week 4 and Week 8