Clinical trial NCT06370325: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
Official title: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Isometric Strength of Gastrocnemius Muscle
timeFrame: Week 6
measure: Isometric Strength of Gastrocnemius Muscle
timeFrame: Week 9
measure: Isometric Strength of Gastrocnemius Muscle
timeFrame: Week 12
measure: Bilateral Calf Circumference
timeFrame: Week 6
measure: Bilateral Calf Circumference
timeFrame: Week 9
measure: Bilateral Calf Circumference
timeFrame: Week 12
Secondary outcomes:
measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score
timeFrame: Week 6
measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score
timeFrame: Week 9
measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score
timeFrame: Week 12
measure: Sit-to-Stand Test
timeFrame: Week 6
measure: Sit-to-Stand Test
timeFrame: Week 9
measure: Sit-to-Stand Test
timeFrame: Week 12
measure: 2 Minute Walk Test
timeFrame: Week 6
measure: 2 Minute Walk Test
timeFrame: Week 9
measure: 2 Minute Walk Test
timeFrame: Week 12
measure: Stair Climb Test
timeFrame: Week 6
measure: Stair Climb Test
timeFrame: Week 9
measure: Stair Climb Test
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Raymond J. Walls, MD
role: PRINCIPAL_INVESTIGATOR
References: