Transfemoral Powered Foot and Physical Therapy Study

Effects of a Powered Ankle-Foot Prosthesis and Device-Specific Physical Therapy on Function and Pain for Individuals Living With Transfemoral Limb Loss

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.

Study Overview

• Status: Recruiting
• Conditions: Prosthesis User; Lower Extremity Problem
• Intervention / Treatment: Behavioral: Powered device with physical therapy; Behavioral: Powered device with standard of practice

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Hyre, MS; Phone Number: 212-951-3339; Email: michael.hyre@va.gov

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • VA New York Harbor Healthcare System
      • Contact: Michael Hyre, MS; Phone Number: 212-951-3339; Email: michael.hyre@va.gov
      • Principal Investigator: Jason Maikos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powered device with physical therapy; 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.	Behavioral: Powered device with physical therapy; Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program.
Active Comparator: Powered device with standard of practice; 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.	Behavioral: Powered device with standard of practice; Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in the current standard of practice training, which includes basic device education and prosthetic training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Evaluation between PT and non-PT groups	Biomechanical evaluation of gait with 3D motion capture while the individual is walking at several different speeds.	Baseline, Week 4, and Week 8
Change in 6 minute walk test between PT and non-PT groups	The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.	Baseline, Week 4, and Week 8
Change in AmpPro between PT and non-PT groups	The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.	Baseline, Week 4, and Week 8
Change in the CHAMP between PT and non-PT groups	The Comprehensive High-Level Activity Mobility Predictor (CHAMP) is a 4-item, more advanced instrument to measure prosthetic mobility for individuals in this study that scored > 38 on the AmpPro	Baseline, Week 4, and Week 8
Change from Baseline in Serial Subtraction at Week 4 and Week 8	Serial Subtraction is a cognitive test where participants are given a random 3 digit number and are asked to subtract by 3s while they walk for 1 minute on a treadmill at a comfortable walking speed. Total number of errors will be documented. Serial subtraction will be performed at baseline using their current prosthetic foot and again at 4- and 8-weeks utilizing the powered prosthesis.	Baseline, Week 4, and Week 8
Change from Baseline in COWAT at Week 4 and Week 8	The Controlled Oral Word Association Test (COWAT) is a cognitive test where participants are asked to list as many words as they can think of beginning with a certain letter while walking for 1 minute on a treadmill at a comfortable speed. The participants will complete 3 rounds (3 letters). The total number of unique words for each letter will be documented. COWAT will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.	Baseline, Week 4, and Week 8
Change from Baseline in Category Test at Week 4 and Week 8	The Category Test is a cognitive test where participants are asked to list as many words as they can think of belonging to a certain category while walking for 1 minute on a treadmill at a comfortable speed. The total number of unique words for the category will be documented. The category test will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.	Baseline, Week 4, and Week 8
Change from Baseline in CNS Vital Signs at Week 8	The CNS Vital Signs is a computerized neurocognitive assessment that assess 5 domains: memory, psychomotor speed, reaction time, complex attention, and cognitive flexibility. Participants will complete the online platform independently.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups	The PEQ is a self-report Visual Analog Scale questionnaire for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.	Baseline, Week 4, and Week 8
Change in Promis Pain Interference levels between PT and non-PT groups	The Promis Pain Interference Scale is an 8-item self-report measure of pain interference over the last 7 days. There are 5 potential answers ranging from "not at all" to "very much" for participants to check off. Participants are only allowed to check off one answer per question.	Baseline, Week 4, and Week 8
Change in Quality of Life scores between PT and non-PT groups	The Quality of Life Scale is a single item visual analog scale used to measure the participants' quality of life over the past four weeks or since their last visit. The visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. The line is 100 mm long and is always measured from the left (0-100). On the left side of the scale (0 mm) it says "worst possible quality of life". On the right side of the scale (100 mm) it says "ideal quality of life, so the higher the score the more positive the response.	Baseline, Week 4, and Week 8
Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups	The PEQ-A 4 Weeks is a free response 2-item questionnaire in which the participant is asked about any falls and/or stumbles over the last four weeks or since his or her last visit.	Baseline, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: VA New York Harbor Healthcare System
• Collaborators: Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Jason Maikos, PhD, Director, VISN 2 Gait and Motion Analysis Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Physical Therapy; Powered Prosthesis; Biomechanical outcomes
• Other Study ID Numbers: IRB #01643; CDMRP-OP160073 (Other Grant/Funding Number: CDMRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No