Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
Recruiting now · Not applicable
Conditions studied: Ankle Fractures
In brief
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.
Key facts
- Study ID
- NCT06370325
- Run by
- NYU Langone Health
- People needed
- 20
- Starts
- 2025-06-19
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Capable and willing to provide informed consent
- Undergoing a procedure that involves repairing an ankle fracture.
You may not qualify if…
- 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 is running
- NYU Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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