NCT06370325

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
PROCEDURE	VPOD Wireless Tens Unit	The VPOD unit will deliver NMES to participants in the Intervention Group.
PROCEDURE	Physical Therapy	Physical therapy as per standard of care.
DEVICE	Biodex	Used to assess strength, endurance, power, and range of motion.

Timeline

• Start date: 2025-06-19
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-04-17
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States