NCT06370325NARecruiting

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

NYU Langone Health

Start Date

6/19/2025

Completion Date

12/30/2026

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

Age Range: 18 years to 70 years

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

Interventions

PROCEDURE

VPOD Wireless Tens Unit

PROCEDURE

Physical Therapy

DEVICE

Biodex

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Conditions

Ankle Fractures

Locations

NYU Langone Health

New York, New York 10016

United States