Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Samsung Medical Center | Seoul | Gangnam-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | Ministry of Health, Republic of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks | |
Secondary | Range of Motion (ROM) on the affected knee | Evaluation of change of ROM in the affected knee from baseline to 24 weeks | Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks | |
Secondary | 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. | Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks | |
Secondary | 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. | Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks | |
Secondary | 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. | Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks |
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