Mild electrical stimulation to boost recovery after ankle fracture surgery
Official title: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
Run by NYU Langone Health · NCT06370325 · Data updated 2026-11-12
This trial will try neuromuscular electrical stimulation for people recovering from ankle fracture repair to see if it improves calf strength and walking and functional ability.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | June 19, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06370325 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ambulatory adults who undergo surgical repair of an ankle fracture, can give informed consent, and do not have contraindications to electrical stimulation.
✕Probably not a fit
Patients with implanted electrical devices, active neurological disorders, non-ambulatory status, recent unrelated surgery, active cancer, cardiac disease, venous thrombosis, or other listed exclusions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pilot randomized controlled trial in which one group will receive neuromuscular electrical stimulation (NMES) five days per week starting three weeks after ankle fracture surgery and continuing for ten weeks while the control group receives usual care. Both groups will begin standard physical therapy six weeks after surgery. The primary outcome is isometric strength of the gastrocnemius muscle measured with objective dynamometry, and secondary outcomes include the Lower Extremity Functional Scale (LEFS), sit-to-stand test, 2-minute walk, stair climb, and calf circumference compared to the uninjured side. The trial is single-center and conducted at NYU Langone Health with typical surgical ankle fracture patients who meet eligibility criteria.
Why it matters
Potential benefit: If successful, the intervention could reduce calf muscle weakness and speed return of walking and functional ability after ankle fracture repair.
How similar studies have gone: NMES has shown benefit for preventing disuse atrophy and improving strength in other orthopedic and rehabilitation settings, but its specific use after ankle fracture surgery is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Capable and willing to provide informed consent * Undergoing a procedure that involves repairing an ankle fracture. Exclusion Criteria: Patients with medical histories that include: * Rheumatoid arthritis * Connective tissue disorders * Chronic corticosteroid use * Implanted electrical devices * Neurological disorders * Non-ambulatory status * Recent surgery (within the last 3 months) that is not related to the study * Scheduled to undergo surgery in the near future * Epilepsy * Diagnosed with cancer * Have suffered acute trauma or recently have had a surgical procedure (not related to the study) * Have cardiac problems or cardiac disease * Have an abdominal hernia * Have venous thrombosis
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Raymond J. Walls, MD — NYU Langone Health
- Study coordinator: Raymond J. Walls, MD
- Email: Raymond.Walls@nyulangone.org
- Phone: (917) 780-8720
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.