Actively Recruiting
Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
Led by NYU Langone Health · Updated on 2026-02-27
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of neuromuscular electrical stimulation (NMES) on patients undergoing surgery to repair ankle fractures. This pilot randomized controlled trial compares an intervention group receiving NMES plus standard physical therapy to a control group receiving only standard physical therapy. The study aims to assess muscle strength and functional recovery after surgery. Participants assigned to the intervention group will use a VPOD Wireless Tens Unit to receive NMES five days a week, starting three weeks after surgery and continuing for ten weeks. Both groups will begin standard physical therapy six weeks postoperatively. The study uses devices like the Biodex to measure muscle strength, endurance, power, and range of motion. Participants will be evaluated at weeks 6, 9, and 12 after surgery. Assessments include isometric strength of the gastrocnemius muscle, calf circumference comparisons, and functional tests such as the Lower Extremity Functional Scale questionnaire, sit-to-stand test, 2-minute walk test, and stair climb test. The trial includes monitoring physical function and muscle recovery over the treatment period to understand the potential benefits of NMES alongside physical therapy.
CONDITIONS
Brief Title
Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable and willing to provide informed consent
- Undergoing a procedure that involves repairing an ankle fracture
- Age between 18 and 70 years
You will not qualify if you...
- History of rheumatoid arthritis
- Presence of connective tissue disorders
- Chronic corticosteroid use
- Presence of implanted electrical devices
- Neurological disorders
- Non-ambulatory status
- Recent surgery within the last 3 months not related to the study
- Scheduled for surgery in the near future
- Epilepsy
- Diagnosis of cancer
- Recent acute trauma or surgical procedure not related to the study
- Cardiac problems or cardiac disease
- Abdominal hernia
- Venous thrombosis history or condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 weeks post-surgery
Participants undergo foot and ankle surgery followed by neuromuscular electrical stimulation (NMES) five days a week starting three weeks after surgery for ten weeks. Standard physical therapy begins at six weeks postoperative.
Weekly visits for neuromuscular electrical stimulation and physical therapy starting at week 3 post-surgery
Duration - Up to 12 weeks post-surgery
Participants are assessed for muscle strength, calf circumference, and functional mobility through various tests to monitor recovery and treatment effects.
3 visits at Weeks 6, 9, and 12 post-surgery
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
R
Raymond J. Walls, MD
T
Thelma Jimenez Mosquea, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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