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

Not Applicable

Terminated

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Device: Wearable Device(exoRehab); Behavioral: Home rehabilitation program

• Registration Number: NCT04079205
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-12-31
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home rehabilitation using Wearable Device	Wearable Device(exoRehab)	Home rehabilitation using Wearable Device(exoRehab)
Control	Home rehabilitation program	Standard home rehabilitation program

Primary Outcome Measures

Name	Time	Method
Quadriceps muscle strength using dynamometry	Baseline and 6 weeks	Change from baseline quadriceps muscle strength at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Active range of motion of knee	Baseline, 2 weeks and 6 weeks	Change from baseline active range of motion of knee at 2 weeks and 6 weeks
Lysholm score	Baseline, 2 weeks and 6 weeks	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.
Knee Outcome Survey-Activities of Daily Living Scale	Baseline, 2 weeks and 6 weeks	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.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score	Baseline, 2 weeks and 6 weeks	Changes from baseline in International Knee Documentation Committee (IKDC) subjective score at 2 weeks and 6 weeks, Higher scores indicate better recovery
Visual Analogue Scale for pain	Baseline, 2 weeks and 6 weeks	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).
Passive range of motion of knee	Baseline, 2 weeks and 6 weeks	Change from baseline passive range of motion of knee at 2 and 6 weeks
EQ-5D-3L Scores	Baseline, 2 weeks and 6 weeks	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".
Root mean square of surface electromyography of quadriceps muscle	Baseline, 2 weeks and 6 weeks	Change from baseline root mean square of surface electromyography of quadriceps muscle at 2 weeks and 6 weeks

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of