NCT06370325 Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
| NCT ID | NCT06370325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Ankle Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-19 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.
Eligibility 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
Contact & Investigator
Raymond J. Walls, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06370325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Ankle Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06370325 currently recruiting?
Yes, NCT06370325 is actively recruiting participants. Contact the research team at Raymond.Walls@nyulangone.org for enrollment information.
Where is the NCT06370325 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06370325 clinical trial?
NCT06370325 is sponsored by NYU Langone Health. The principal investigator is Raymond J. Walls, MD at NYU Langone Health. The trial plans to enroll 20 participants.