Last reviewed · How we verify
NCT03625921
Transfemoral Powered Foot and Physical Therapy Study
NA trial testing Powered device with physical therapy in Lower Extremity Problem in 20 participants. Participants enrolled and being followed up; not accepting new ones.
14 January 2025
Quick facts
| Lead sponsor | VA New York Harbor Healthcare System |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 17 November 2017 |
| Primary completion | 14 January 2025 |
| Estimated completion | 14 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Powered device with physical therapy
- Powered device with standard of practice
Conditions studied
- Lower Extremity Problem — all drugs for Lower Extremity Problem →
- Prosthesis User — all drugs for Prosthesis User →
Sponsor
VA New York Harbor Healthcare System — full company profile →
Who can join
18 and older, any sex, with Lower Extremity Problem or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Maikos JT, Pruziner AL, Hendershot BD, Herlihy DV, et al · · 2024 · cited 2× · PMID 38277197 · DOI 10.2196/53412
Verify or expand the search:
- PubMed search for NCT03625921
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lower Extremity Problem
Currently open trials in the same condition.
- NCT06016647 — Multi-axis Assessment of Injured Workers · recruiting
- NCT04861506 — The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity. · recruiting
Other VA New York Harbor Healthcare System trials
Trials by the same sponsor.
- NCT03505983 — Criteria for Advanced Prosthetic Foot Prescription · NA · active not recruiting
- NCT03945136 — Implementation of Brief Dynamic Interpersonal Therapy at the VA · unknown
- NCT01677533 — Program for Research on the Outcomes of VA Education · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03625921 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA New York Harbor Healthcare System
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03625921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing