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

Frozen Shoulder Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316130
• Other study ID #: SMC-2019-05-021
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Device:
• Uincare Homeplus
Interactive digital healthcare system

Other:
• Brochure
Brochure

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion (ROM) in affected shoulder	Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary	Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)	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.	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary	Numerical rating scale (NRS) of affected shoulder	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.	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary	Quality of life in the patients with frozen shoulder using Short form -36 (SF36)	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.	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary	Quality of life in the patients with frozen shoulder 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 the worst quality of life you can imagine.	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary	Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)	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.	Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks