Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
ConditionAnkle Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
Capable and willing to provide informed consent
Undergoing a procedure that involves repairing an ankle fracture.
Disqualifiers
Rheumatoid arthritis
Connective tissue disorders
Chronic corticosteroid use
Implanted electrical devices
Trial design
Design model
Parallel
Treatments tested in this trial
VPOD Wireless Tens Unit
Procedure/SurgeryThe VPOD unit will deliver NMES to participants in the Intervention Group.
Physical Therapy
Procedure/SurgeryPhysical therapy as per standard of care.
Biodex
DeviceUsed to assess strength, endurance, power, and range of motion.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Time frame
Week 62
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Time frame
Week 93
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Time frame
Week 124
Bilateral Calf Circumference
Time frame
Week 6Secondary outcomes
1
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.
Time frame
Week 62
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.
Time frame
Week 93
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.
Time frame
Week 124
Sit-to-Stand Test
The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.
Time frame
Week 6Sponsors and contacts
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Source ClinicalTrials.gov