Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VPOD Wireless Tens Unit, Physical Therapy, Biodex.
- Who it may be relevant to
- Registry conditions: Ankle Fractures. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Isometric Strength of Gastrocnemius Muscle [Time frame: Week 6]
- Isometric Strength of Gastrocnemius Muscle [Time frame: Week 9]
- Isometric Strength of Gastrocnemius Muscle [Time frame: Week 12]
- Bilateral Calf Circumference [Time frame: Week 6]
- Bilateral Calf Circumference [Time frame: Week 9]
- Bilateral Calf Circumference [Time frame: Week 12]
Secondary outcome measures (12)
- Lower Extremity Functional Scale (LEFS) Questionnaire Score [Time frame: Week 6]
- Lower Extremity Functional Scale (LEFS) Questionnaire Score [Time frame: Week 9]
- Lower Extremity Functional Scale (LEFS) Questionnaire Score [Time frame: Week 12]
- Sit-to-Stand Test [Time frame: Week 6]
- Sit-to-Stand Test [Time frame: Week 9]
- Sit-to-Stand Test [Time frame: Week 12]
- 2 Minute Walk Test [Time frame: Week 6]
- 2 Minute Walk Test [Time frame: Week 9]
- 2 Minute Walk Test [Time frame: Week 12]
- Stair Climb Test [Time frame: Week 6]
- Stair Climb Test [Time frame: Week 9]
- Stair Climb Test [Time frame: Week 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06370325 · 23-00987