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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The VPOD unit will deliver NMES to participants in the Intervention Group.
Physical therapy as per standard of care.
Used to assess strength, endurance, power, and range of motion.
NYU Langone Health
New York, New York, United States
RECRUITINGIsometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Time frame: Week 6
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Time frame: Week 9
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
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
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 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.
Time frame: 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.
Time frame: Week 12
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 6
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 9
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 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
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