Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

Detailed Description
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This randomized, single-blind, controlled trial included 40 patients who are discharged after ACL reconstruction. The intervention group(n=20) was instructed and educated about 6 week home rehabilitation program using a wearable device(exoRehab) The controls(n=20) was instructed and educated about 6 week conventional home rehabilitation program Two weeks after surgery and six weeks after discharge, evaluation is performed. The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

Official Title
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Home-based Rehabilitation Using Smart Wearable Knee Exercise Device With Electrical Stimulation After Anterior Cruciate Ligament Reconstruction: A Study Protocol for a Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Device: Wearable Device(exoRehab)
* Behavioral: Home rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with anterior cruciate ligament reconstruction Patients who are older than 19 years of age Exclusion Criteria: History of surgery or traumatic injury to the uninvolved lower extremity Complication after ACL reconstruction surgery Dermatological conditions affecting the thigh Body mass index (BMI) greater than 40 kg/m2 Implanted pacemakers or defibrillators Significant neurologic impairments Other unstable lower-extremity orthopedic conditions Initiated rehabilitation at another facility prior to their first physical therapy session at our facility Other lower limb impairment affecting function More than one surgery for a tear of the ACL

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home rehabilitation using Wearable Device<br>Home rehabilitation using Wearable Device(exoRehab) | Device: Wearable Device(exoRehab)<br>* rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)<br>|
| Active Comparator: Control<br>Standard home rehabilitation program | Behavioral: Home rehabilitation program<br>* rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps muscle strength using dynamometry | Change from baseline quadriceps muscle strength at 6 weeks | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active range of motion of knee | Change from baseline active range of motion of knee at 2 weeks and 6 weeks | Baseline, 2 weeks and 6 weeks | 
| Passive range of motion of knee | Change from baseline passive range of motion of knee at 2 and 6 weeks | Baseline, 2 weeks and 6 weeks | 
| Root mean square of surface electromyography of quadriceps muscle | Change from baseline root mean square of surface electromyography of quadriceps muscle at 2 weeks and 6 weeks | Baseline, 2 weeks and 6 weeks | 
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score | Changes from baseline in International Knee Documentation Committee (IKDC) subjective score at 2 weeks and 6 weeks, Higher scores indicate better recovery | Baseline, 2 weeks and 6 weeks | 
| Lysholm score | Change from baseline in Lysholm score at 2 weeks and 6 weeks. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. | Baseline, 2 weeks and 6 weeks | 
| Knee Outcome Survey-Activities of Daily Living Scale | Change from baseline in score of Knee Outcome Survey-Activities of Daily Living Scale at 2 weeks and 6 weeks. Score ranges from 0-100 with higher scores indicating better knee joint function. | Baseline, 2 weeks and 6 weeks | 
| EQ-5D-3L Scores | Change from baseline in EQ-5D-3L Scores at 2 weeks and 6 weeks. EQ-5D-3L is made up for two components. First, the health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. Second, the evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to  the worst health you can imagine, and hundred corresponds to the best health you can imagine. | Baseline, 2 weeks and 6 weeks | 
| Visual Analogue Scale for pain | Change from baseline in Visual Analogue Scale at 2 weeks and 6 weeks. The Visual Analogue Scale(VAS), a 101-point scale for evaluating pain which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). | Baseline, 2 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Reconstruction, Wearable device, Knee, Neuromuscular Electrical Stimulation, Exercise