Clinical trial NCT03625921: Transfemoral Powered Foot and Physical Therapy Study
Official title: Effects of a Powered Ankle-Foot Prosthesis and Device-Specific Physical Therapy on Function and Pain for Individuals Living With Transfemoral Limb Loss
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Extremity Problem
Prosthesis User
Keywords: Physical Therapy
Powered Prosthesis
Biomechanical outcomes
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
First posted: 2018-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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 changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
* Weigh more than 287 pounds at screening
* Use of non-prescribed opioids or over-use of any prescription drugs
* Major upper limb amputation
* Currently uses a powered ankle-foot prosthesis as a primary prosthesis or used a powered ankle-foot device as a primary prosthesis in the previous 6 months
* Any cardio-pulmonary, metabolic or integumentary diagnosis where walking for 15 minutes is contraindicated

Primary outcomes:
measure: Change in Gait Evaluation between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in 6 minute walk test between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in AmpPro between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in the CHAMP between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change from Baseline in Serial Subtraction at Week 4 and Week 8
timeFrame: Baseline, Week 4, and Week 8
measure: Change from Baseline in COWAT at Week 4 and Week 8
timeFrame: Baseline, Week 4, and Week 8
measure: Change from Baseline in Category Test at Week 4 and Week 8
timeFrame: Baseline, Week 4, and Week 8
measure: Change from Baseline in CNS Vital Signs at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in Promis Pain Interference levels between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in Quality of Life scores between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
measure: Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups
timeFrame: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System
state: New York
Study officials:
affiliation: Director, VISN 2 Gait and Motion Analysis Laboratory
name: Jason Maikos, PhD
role: PRINCIPAL_INVESTIGATOR
References: