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Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

NCT06370325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Raymond J. Walls, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370325 on ClinicalTrials.gov