Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction
New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJanuary 5, 2022
January 1, 2022
2.4 years
August 9, 2020
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary Outcomes (5)
Numerical Rating Scale (NRS) on the affected knee
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected knee
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected lower extremities
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
International Knee Documentation Committee (IKDC) score on the affected knee
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Quality of Life using EQ-5D-5L
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Study Arms (2)
Digital Healthcare System Rehabilitation
EXPERIMENTALConventional Rehabilitation
ACTIVE COMPARATORInterventions
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.
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Eligibility Criteria
You may qualify if:
- Patient who had anterior cruciate ligament reconstruction surgery
- Patient who is discharged to home after surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Related Publications (1)
Lim JY, Yu HJ, Kim SH, Lee JI, Lim JY, Wang JH, Hwang JH. Effectiveness of In-Home, Augmented Reality-Based Telerehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Oct 15;12(10):23259671241271729. doi: 10.1177/23259671241271729. eCollection 2024 Oct.
PMID: 39415796DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2020
First Posted
August 14, 2020
Study Start
July 30, 2020
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
January 5, 2022
Record last verified: 2022-01