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ACTIVE NOT RECRUITING NA

Transfemoral Powered Foot and Physical Therapy Study

NCT03625921 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BEHAVIORAL Powered device with physical therapy
  • BEHAVIORAL Powered device with standard of practice

Study Locations (1)

New York

  • VA New York Harbor Healthcare System — New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-11-17
Est. Completion 2026-01-14
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03625921

The ClinicalTrials.gov registry entry for NCT03625921 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA New York Harbor Healthcare System, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Prosthesis User appearing as the primary indexed condition, and to 2 interventions — of which Powered device with physical therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03625921 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03625921 about?

NCT03625921 is a clinical study titled "Transfemoral Powered Foot and Physical Therapy Study". 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, functiona...

What is the current status of trial NCT03625921?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2017-11-17. Estimated completion is 2026-01-14.

What conditions does trial NCT03625921 study?

This clinical trial studies the following conditions: Prosthesis User, Lower Extremity Problem. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03625921?

The interventions under investigation include: Powered device with physical therapy (BEHAVIORAL), Powered device with standard of practice (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03625921?

This trial is sponsored by VA New York Harbor Healthcare System, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03625921 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial