Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial, Assessor Blinding, Multi-center Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frozen Shoulder
- Sponsor
- Samsung Medical Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Range of motion (ROM) in affected shoulder
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. 100 frozen shoulder who diagnosed with limited range of motion in 2 more plane of flexion, abduction, external rotation of affected shoulder. Shoulder range of motion (ROM), Shoulder Pain and Disability Index (SPADI), pain evaluation with Numeral Rating Scale (NRS), quality of life evaluation with Short Form (SF)-36 Health Survey and EQ-5D-5L, activity daily living (ADL) evaluation with Canadian Occupational Performance Measure (COPM) will be evaluated on enrollment, 4-week, 8-week, 12-weeks, 18-weeks, and 24 weeks after enrollment.
Detailed Description
The frozen shoulder is a disease in which severe pain and limited range of motion of the shoulder occur as an inflammatory change occurs in the articular capsular surrounding the shoulder joint. As a result, it has caused limitation in daily life movement. Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately. The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder.
Investigators
JiHye Hwang
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Limited passive range of motion of the affected shoulder in 2 more plane (flexion \< 150˚, abduction \<150˚, external rotation \< 60˚)
Exclusion Criteria
- •Bilateral frozen shoulder
- •Secondary frozen shoulder caused by trauma (shoulder fracture, dislocation), or/and inflammatory disease(rheumatoid arthritis)
- •Those unable to perform exercise due to general deconditioning
- •Those with communication difficulty
Outcomes
Primary Outcomes
Range of motion (ROM) in affected shoulder
Time Frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks
Secondary Outcomes
- Numerical rating scale (NRS) of affected shoulder(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Quality of life in the patients with frozen shoulder using EQ-5D-5L(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Quality of life in the patients with frozen shoulder using Short form -36 (SF36)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)