Recruiting

NMES

Sponsor:

NYU Langone Health

Code:

NCT06370325

Conditions

Ankle Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VPOD Wireless Tens Unit

Physical Therapy

Biodex

Study Details

Brief 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

Study ID

NCT06370325

Start date

Jun 19, 2025

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

VPOD Wireless Tens Unit

The VPOD unit will deliver NMES to participants in the Intervention Group.

Physical Therapy

Physical therapy as per standard of care.

Biodex

Used to assess strength, endurance, power, and range of motion.

Primary outcome measure

  • Isometric Strength of Gastrocnemius Muscle [ Time Frame: Week 6 ]
  • Isometric Strength of Gastrocnemius Muscle [ Time Frame: Week 9 ]
  • Isometric Strength of Gastrocnemius Muscle [ Time Frame: Week 12 ]
  • Bilateral Calf Circumference [ Time Frame: Week 6 ]
  • Bilateral Calf Circumference [ Time Frame: Week 9 ]
  • Bilateral Calf Circumference [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Raymond J. Walls, MD

(917) 780-8720Raymond.Walls@nyulangone.org

Thelma Jimenez Mosquea, MD

(347) 880-2254Thelma.JimenezMosquea@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-27.