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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04079205
• Other study ID #: B-1806-475-006
• Status: Terminated
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• Wearable Device(exoRehab)
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)

Behavioral:
• Home rehabilitation program
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Exosystems CO.,Ltd, Ministry of SMEs and Startups, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps muscle strength using dynamometry	Change from baseline quadriceps muscle strength at 6 weeks	Baseline and 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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