Transfemoral Powered Foot and Physical Therapy Study

NCT03625921 | Active Not Recruiting

• 2 other identifiers: IRB #01643CDMRP-OP160073
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Problem; Prosthesis User

Keywords

Physical Therapy; Powered Prosthesis; Biomechanical outcomes

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups

  Baseline, Week 4, and Week 8

• Change in Promis Pain Interference levels between PT and non-PT groups

  Baseline, Week 4, and Week 8

• Change in Quality of Life scores between PT and non-PT groups

  Baseline, Week 4, and Week 8

• Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups

  Baseline, Week 4, and Week 8

Study Arms (2)

Powered device with physical therapy

EXPERIMENTAL

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

Powered device with standard of practice

ACTIVE COMPARATOR

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

Interventions

Powered device with physical therapy BEHAVIORAL

Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program.

Powered device with physical therapy

Powered device with standard of practice BEHAVIORAL

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.

Powered device with standard of practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

Related Publications (1)

• Maikos JT, Pruziner AL, Hendershot BD, Herlihy DV, Chomack JM, Hyre MJ, Phillips SL, Sidiropoulos AN, Dearth CL, Nelson LM. Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals With Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multisite Clinical Trial. JMIR Res Protoc. 2024 Jan 26;13:e53412. doi: 10.2196/53412.

  PMID: 38277197 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Jason Maikos, PhD

  Director, VISN 2 Gait and Motion Analysis Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, VISN 2 Gait and Motion Analysis Laboratory

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: August 10, 2018
• Study Start: November 17, 2017
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)