Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Not Applicable

Not yet recruiting

• Conditions: Ankle Fractures
• Interventions: Procedure: VPOD Wireless Tens Unit; Procedure: Physical Therapy; Device: Biodex

• Registration Number: NCT06370325
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Study Start: 2025-05-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	VPOD Wireless Tens Unit	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.
Intervention Group	Physical Therapy	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.
Intervention Group	Biodex	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.
Control Group	Biodex	Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.
Control Group	Physical Therapy	Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Primary Outcome Measures

Name	Time	Method
Isometric Strength of Gastrocnemius Muscle	Week 12	Measured using Biodex dynamometer.
Bilateral Calf Circumference	Week 12

Secondary Outcome Measures

Name	Time	Method
Sit-to-Stand Test	Week 12	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.
Stair Climb Test	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.
2 Minute Walk Test	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
Lower Extremity Functional Scale (LEFS) Questionnaire Score	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States