Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Conventional Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior Cruciate Ligament Reconstruction, Post-Operative Rehabilitation, Digital Healthcare System
Eligibility Criteria
Inclusion Criteria:
- Patient who had anterior cruciate ligament reconstruction surgery
- Patient who is discharged to home after surgery
Exclusion Criteria:
- Patient who had previous history of anterior cruciate ligament reconstruction surgery in the past 6 months.
- Patient who had undergone bilateral anterior cruciate ligament reconstruction surgery.
- Patient who has knee joint disorders (rheumatoid arthritis, osteoarthritis) other than anterior cruciate ligament injury.
- Patient who has neurological deficit or infection in the affected knee joint.
- Patient who has severe comorbidity that inhibits exercise.
- Patient who cannot participate in post surgery rehabilitation
Sites / Locations
- Samsung Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital Healthcare System Rehabilitation
Conventional Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Changes from baseline Limb Symmetry Index (LSI) of lower extremities
LSI(%) = (involved limb knee flexor and extensor manual muscle test score / uninvolved limb knee flexor and extensor manual muscle test score * 100). LSI ranges from 0-100 with higher score meaning better limb symmetry.
Secondary Outcome Measures
Numerical Rating Scale (NRS) on the affected knee
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain). Higher score meaning worse pain.
Range of Motion (ROM) on the affected knee
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
Manual Muscle Test (MMT) on the affected lower extremities
Evaluation of change of MMT in the affected lower extremities from baseline to 24 weeks. Affected lower extremity MMT ranges from 0-25 with higher score meaning better motor power.
International Knee Documentation Committee (IKDC) score on the affected knee
IKDC score is a self-reported measure, 18 items (7 on symptoms, 1 on participation in sports, 9 on daily activities, and 1 on current knee function). IKDC score ranges from 0-100, with higher score meaning better function.
Quality of Life using EQ-5D-5L
Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. Lower value means worse quality of life.
Full Information
NCT ID
NCT04513327
First Posted
August 9, 2020
Last Updated
January 4, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04513327
Brief Title
Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction
Official Title
New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with anterior cruciate ligament reconstruction. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Limb Symmetry Index (LSI), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), International Knee Documentation Committee (IKDC) and quality of life using EQ-5D-5L will be evaluation on enrollment, 2-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.
Detailed Description
Anterior cruciate ligament(ACL) is a vital structure in the knee maintaining the stability and due to increased population engaging in sports activities, the ACL injury is becoming more prevalent among young adults. Rehabilitation after ACL reconstruction is essential to restore knee function and many factors including age, degree of sports activities engagement, weight bearing should be considered when organizing rehabilitation programs. Knee joint stiffness and weakness of knee flexor/extensor muscles are common problems following the surgery which are related to improper rehabilitation after ACL reconstructions.
Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.
With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback. In this prospective randomized controlled study, the investigators aim to compare the efficacy of the newlydeveloped digital healthcare system with conventional rehabilitation program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Anterior Cruciate Ligament Reconstruction, Post-Operative Rehabilitation, Digital Healthcare System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital Healthcare System Rehabilitation
Arm Type
Experimental
Arm Title
Conventional Rehabilitation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Other Intervention Name(s)
Uincare Homeplus
Intervention Description
Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to anterior cruciate ligament reconstruction post-op rehabilitation at home.
Home-based self-rehabilitation using brochure for 2 weeks post surgery (same as the active comparator)
Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 2 to 12 weeks post surgery.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Primary Outcome Measure Information:
Title
Changes from baseline Limb Symmetry Index (LSI) of lower extremities
Description
LSI(%) = (involved limb knee flexor and extensor manual muscle test score / uninvolved limb knee flexor and extensor manual muscle test score * 100). LSI ranges from 0-100 with higher score meaning better limb symmetry.
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) on the affected knee
Description
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain). Higher score meaning worse pain.
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Range of Motion (ROM) on the affected knee
Description
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Manual Muscle Test (MMT) on the affected lower extremities
Description
Evaluation of change of MMT in the affected lower extremities from baseline to 24 weeks. Affected lower extremity MMT ranges from 0-25 with higher score meaning better motor power.
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Title
International Knee Documentation Committee (IKDC) score on the affected knee
Description
IKDC score is a self-reported measure, 18 items (7 on symptoms, 1 on participation in sports, 9 on daily activities, and 1 on current knee function). IKDC score ranges from 0-100, with higher score meaning better function.
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Quality of Life using EQ-5D-5L
Description
Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. Lower value means worse quality of life.
Time Frame
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who had anterior cruciate ligament reconstruction surgery
Patient who is discharged to home after surgery
Exclusion Criteria:
Patient who had previous history of anterior cruciate ligament reconstruction surgery in the past 6 months.
Patient who had undergone bilateral anterior cruciate ligament reconstruction surgery.
Patient who has knee joint disorders (rheumatoid arthritis, osteoarthritis) other than anterior cruciate ligament injury.
Patient who has neurological deficit or infection in the affected knee joint.
Patient who has severe comorbidity that inhibits exercise.
Patient who cannot participate in post surgery rehabilitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay-Young Lim, M.D., Ph. D
Phone
+82-31-787-7732
Email
drlim1@snu.ac.kr
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIHYE HWANG, M.D. Ph. D.
Phone
+82-10-9933-2816
Email
jhlee.hwang@samsung.com
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph.D.
Phone
+82-10-5390-0373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph. D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction
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