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NCT06370325 | NOT YET RECRUITING | Ankle Fractures


Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
Sponsor:

NYU Langone Health

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.

Condition or disease

Ankle Fractures

Intervention/treatment

VPOD Wireless Tens Unit

Physical Therapy

Biodex

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Location Details

NCT06370325


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016

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