Clinical trial NCT04316130: Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Range of motion (ROM) in affected shoulder
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary outcomes:
measure: Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
measure: Numerical rating scale (NRS) of affected shoulder
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
measure: Quality of life in the patients with frozen shoulder using Short form -36 (SF36)
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
measure: Quality of life in the patients with frozen shoulder using EQ-5D-5L
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
measure: Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)
timeFrame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
state: Seocho-gu
Study officials:
affiliation: Physical & Rehabilitation Medicine Samsung Medical Center
name: JIHYE HWANG, Professor
role: STUDY_CHAIR
References:
citation: Yeo SM, Lim JY, Do JG, Lim JY, In Lee J, Hwang JH. Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 26;22(1):386. doi: 10.1186/s12891-021-04261-1.