Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06370325
Status
Recruiting
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Conditions

  • Ankle Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 19, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Participants randomized to the intervention group will undergo neuromuscular electrical stimulation (NMES) five days a week beginning three weeks postoperative and lasting for ten weeks. The intervention group will begin standard physical therapy at six weeks postoperative.
  • Active Comparator: Control Group
    Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Primary Outcome Measure

Isometric Strength of Gastrocnemius Muscle [ Time Frame: Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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