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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | Active Comparator | Participants randomized to the control group will begin standard physical therapy at six weeks postoperative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPOD Wireless Tens Unit | Procedure | The VPOD unit will deliver NMES to participants in the Intervention Group. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with medical histories that include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raymond J. Walls, MD | Contact | (917) 780-8720 | Raymond.Walls@nyulangone.org | |
| Thelma Jimenez Mosquea, MD | Contact | (347) 880-2254 | Thelma.JimenezMosquea@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Raymond J. Walls, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
Data to be used only by the research team.
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical Therapy | Procedure | Physical therapy as per standard of care. |
|
| Biodex | Device | Used to assess strength, endurance, power, and range of motion. |
|
| 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 |