RecruitingNot ApplicableNCT06370325

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

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


Sponsor

NYU Langone Health

Enrollment

20 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Capable and willing to provide informed consent
  • Undergoing a procedure that involves repairing an ankle fracture.

Exclusion Criteria15

  • 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

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Interventions

PROCEDUREVPOD Wireless Tens Unit

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

PROCEDUREPhysical Therapy

Physical therapy as per standard of care.

DEVICEBiodex

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


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06370325


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