Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Procedure: VPOD Wireless Tens Unit; Procedure: Physical Therapy; Device: Biodex

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond J. Walls, MD; Phone Number: (917) 780-8720; Email: Raymond.Walls@nyulangone.org
• Study Contact Backup: Name: Thelma Jimenez Mosquea, MD; Phone Number: (347) 880-2254; Email: Thelma.JimenezMosquea@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Procedure: VPOD Wireless Tens Unit; The VPOD unit will deliver NMES to participants in the Intervention Group.; Procedure: Physical Therapy; Physical therapy as per standard of care.; Device: Biodex; Used to assess strength, endurance, power, and range of motion.
Active Comparator: Control Group; Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.	Procedure: Physical Therapy; Physical therapy as per standard of care.; Device: Biodex; Used to assess strength, endurance, power, and range of motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 6
Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 9
Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 12
Bilateral Calf Circumference		Week 6
Bilateral Calf Circumference		Week 9
Bilateral Calf Circumference		Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Functional Scale (LEFS) Questionnaire Score	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.	Week 6
Lower Extremity Functional Scale (LEFS) Questionnaire Score	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.	Week 9
Lower Extremity Functional Scale (LEFS) Questionnaire Score	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.	Week 12
Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 6
Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 9
Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 12
2 Minute Walk Test	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	Week 6
2 Minute Walk Test	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	Week 9
2 Minute Walk Test	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	Week 12
Stair Climb Test	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.	Week 6
Stair Climb Test	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.	Week 9
Stair Climb Test	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.	Week 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Raymond J. Walls, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: 23-00987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data to be used only by the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No