Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

VPOD Wireless Tens Unit

Intervention Type PROCEDURE

The VPOD unit will deliver NMES to participants in the Intervention Group.

Physical Therapy

Intervention Type PROCEDURE

Physical therapy as per standard of care.

Biodex

Intervention Type DEVICE

Used to assess strength, endurance, power, and range of motion.

Control Group

Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type PROCEDURE

Physical therapy as per standard of care.

Biodex

Intervention Type DEVICE

Used to assess strength, endurance, power, and range of motion.

Interventions

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VPOD Wireless Tens Unit

The VPOD unit will deliver NMES to participants in the Intervention Group.

Intervention Type PROCEDURE

Physical Therapy

Physical therapy as per standard of care.

Intervention Type PROCEDURE

Biodex

Used to assess strength, endurance, power, and range of motion.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No