Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

NYU Langone Health

Status: Not yet enrolling

Conditions: Ankle Fractures

Treatments: Procedure: VPOD Wireless Tens Unit; Device: Biodex; Procedure: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06370325

23-00987

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Procedure: Physical Therapy

Device: Biodex

Procedure: VPOD Wireless Tens Unit

Control Group

Active Comparator group

Description:

Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Treatment:

Procedure: Physical Therapy

Device: Biodex