Development of Rehabilitation Program for Patients After Anterior Cruciate Ligament Reconstruction Using Wearable Device

Overview

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).

Full Title of Study: “Development of Rehabilitation Program for Patients After Anterior Cruciate Ligament Reconstruction Using Wearable Device (exoRehab) : a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2019

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).

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Home rehabilitation using Wearable Device
    • Home rehabilitation using Wearable Device(exoRehab)
  • Active Comparator: Control
    • Standard home rehabilitation program

Clinical Trial Outcome Measures

Primary Measures

  • Quadriceps muscle strength using dynamometry
    • Time Frame: Baseline and 6 weeks
    • Change from baseline quadriceps muscle strength at 6 weeks

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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”.
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Collaborator
    • Ministry of SMEs and Startups, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nam-Jong Paik, Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Nam-Jong Paik, Ph.D, Principal Investigator, Seoul National University Bundang Hospital, Seongnam, South Korea
  • Overall Contact(s)
    • Nam-Jong Paik, Ph.D, 82-31-787-7731, njpaik@snu.ac.kr

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