Ankle Fractures
Conditions
Brief 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.
Interventions
PROCEDUREVPOD Wireless Tens Unit
The VPOD unit will deliver NMES to participants in the Intervention Group.
PROCEDUREPhysical Therapy
Physical therapy as per standard of care.
DEVICEBiodex
Used to assess strength, endurance, power, and range of motion.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isometric Strength of Gastrocnemius Muscle | Week 6 | Measured using Biodex dynamometer. |
| Bilateral Calf Circumference | Week 6 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Functional Scale (LEFS) Questionnaire Score | Week 6 | 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. |
| Sit-to-Stand Test | Week 6 | The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds. |
| 2 Minute Walk Test | Week 6 | 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 |
| Stair Climb Test | Week 6 | 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. |
Countries
United States
Contacts
CONTACTRaymond J. Walls, MD
CONTACTThelma Jimenez Mosquea, MD
PRINCIPAL_INVESTIGATORRaymond J. Walls, MD
NYU Langone Health
Outcome results
None listed