Transfemoral Powered Foot and Physical Therapy Study

VA New York Harbor Healthcare System

Status: Active, not recruiting

Conditions: Lower Extremity Problem; Prosthesis User

Treatments: Behavioral: Powered device with standard of practice; Behavioral: Powered device with physical therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03625921

IRB #01643

CDMRP-OP160073 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Powered device with physical therapy

Experimental group

Description:

Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided an intensive device-specific physical therapy (PT) intervention. The subjects will complete, on average, 8 PT training sessions lasting 30 - 45 minutes each. The subjects will also be provided with a home exercise program.

Treatment:

Behavioral: Powered device with physical therapy

Powered device with standard of practice

Active Comparator group

Description:

Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided the current standard of practice training for use of this powered prosthesis. The prosthetist will confirm a stable and comfortable alignment and educate the subject on proper home usage. Next, the subject will undergo a 45 - 60 minute training with a physical therapist that is characteristic of the current standard of practice.

Treatment:

Behavioral: Powered device with standard of practice