Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Frozen Shoulder
• Interventions: Other: Brochure; Device: Uincare Homeplus

• Registration Number: NCT04316130
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-02
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise using brochure	Brochure	brochure
Exercise using Uincare Homeplus	Uincare Homeplus	Uincare Homeplus

Primary Outcome Measures

Name	Time	Method
Range of motion (ROM) in affected shoulder	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 Outcome Measures

Name	Time	Method
Numerical rating scale (NRS) of affected shoulder	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks	Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain) minimum \~ maximum value: 0 \~ 10, higher scores mean worse outcome.
Quality of life in the patients with frozen shoulder using EQ-5D-5L	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks	Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means the worst quality of life you can imagine.
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	Evaluation of quality of life using SF36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
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	Evaluation of shoulder function (pain and disability) using SPADI. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
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	Evaluation of quality of life using COPM PERFORMANCE and SATISFACTION scores can be generated for up to 5 individual occupational performance problems. Average PERFORMANCE and SATISFACTION scores can be calculated by summing individual problem scores and dividing by the number of problems. Change scores for both PERFORMANCE and SATISFACTION can be calculated after a reassessment interval.

Trial Locations

Locations (2)

Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of