MedTrace Logo

Transfemoral Powered Foot and Physical Therapy Study

NCT03625921 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-06

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • VA New York Harbor Healthcare System

    lead FED

Principal Investigators

  • Jason Maikos, PhD · Director, VISN 2 Gait and Motion Analysis Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2025-01-14
Completion
2026-01-14

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625921 on ClinicalTrials.gov