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NCT Number: NCT06370325

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

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.

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Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Isometric Strength of Gastrocnemius Muscle

    Time frame: Week 6

    Measured using Biodex dynamometer.

  2. Isometric Strength of Gastrocnemius Muscle

    Time frame: Week 9

    Measured using Biodex dynamometer.

  3. Isometric Strength of Gastrocnemius Muscle

    Time frame: Week 12

    Measured using Biodex dynamometer.

  4. Bilateral Calf Circumference

    Time frame: Week 6

  5. Bilateral Calf Circumference

    Time frame: Week 9

  6. Bilateral Calf Circumference

    Time frame: Week 12

Secondary outcomes

  1. Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Time frame: Week 6

    LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.

  2. Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Time frame: Week 9

    LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.

  3. Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Time frame: Week 12

    LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.

  4. Sit-to-Stand Test

    Time frame: Week 6

    The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.

  5. Sit-to-Stand Test

    Time frame: Week 9

    The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.

  6. Sit-to-Stand Test

    Time frame: Week 12

    The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.

  7. 2 Minute Walk Test

    Time frame: Week 6

    In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured

  8. 2 Minute Walk Test

    Time frame: Week 9

    In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured

  9. 2 Minute Walk Test

    Time frame: Week 12

    In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured

  10. Stair Climb Test

    Time frame: Week 6

    The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.

  11. Stair Climb Test

    Time frame: Week 9

    The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.

  12. Stair Climb Test

    Time frame: Week 12

    The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond J. Walls, MD

CONTACT

[email protected]

(917) 780-8720

Thelma Jimenez Mosquea, MD

CONTACT

[email protected]

(347) 880-2254

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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