Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370325
• Other study ID #: 23-00987
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Raymond J. Walls, MD
• Phone: (917) 780-8720
• Email: Raymond.Walls[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures

Intervention

Procedure:
• VPOD Wireless Tens Unit
The VPOD unit will deliver NMES to participants in the Intervention Group.
• Physical Therapy
Physical therapy as per standard of care.

Device:
• Biodex
Used to assess strength, endurance, power, and range of motion.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 6
Primary	Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 9
Primary	Isometric Strength of Gastrocnemius Muscle	Measured using Biodex dynamometer.	Week 12
Primary	Bilateral Calf Circumference		Week 6
Primary	Bilateral Calf Circumference		Week 9
Primary	Bilateral Calf Circumference		Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 6
Secondary	Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 9
Secondary	Sit-to-Stand Test	The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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