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

September 20, 2021 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps muscle strength using dynamometry
Time Frame: Baseline and 6 weeks
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
Time Frame: Baseline, 2 weeks and 6 weeks
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
Time Frame: Baseline, 2 weeks and 6 weeks
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
Time Frame: Baseline, 2 weeks and 6 weeks
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
Time Frame: 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
Baseline, 2 weeks and 6 weeks
Lysholm score
Time Frame: 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.
Baseline, 2 weeks and 6 weeks
Knee Outcome Survey-Activities of Daily Living Scale
Time Frame: 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.
Baseline, 2 weeks and 6 weeks
EQ-5D-3L Scores
Time Frame: 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".
Baseline, 2 weeks and 6 weeks
Visual Analogue Scale for pain
Time Frame: 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).
Baseline, 2 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of SMEs and Startups, Korea
Exosystems CO.,Ltd

Investigators

  • Principal Investigator: Nam-Jong Paik, Ph.D, Seoul National University Bundang Hospital, Seongnam, South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B-1806-475-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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