NCT04316130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

March 18, 2020

Last Update Submit

January 2, 2022

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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 Short form -36 (SF36)

    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

  • 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

Study Arms (2)

Exercise using Uincare Homeplus

EXPERIMENTAL

Uincare Homeplus

Device: Uincare Homeplus

Exercise using brochure

ACTIVE COMPARATOR

brochure

Other: Brochure

Interventions

Uincare HomeplusDEVICE

Interactive digital healthcare system

Also known as: digital healthcare
Exercise using Uincare Homeplus
BrochureOTHER

Brochure

Exercise using brochure

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Limited passive range of motion of the affected shoulder in 2 more plane (flexion \< 150˚, abduction \<150˚, external rotation \< 60˚)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, Seocho-gu, 06591, South Korea

Location

Related Publications (2)

  • Yeo SM, Lim JY, Kim S, Park HY, Lim JY, Do JG, Lee JI, Hwang JH. Effects of augmented reality-based telerehabilitation in adhesive capsulitis of the shoulder: a randomized controlled trial. Ann Phys Rehabil Med. 2025 Jun;68(5):101956. doi: 10.1016/j.rehab.2025.101956. Epub 2025 Jun 27.

    PMID: 40580799DERIVED

  • 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.

    PMID: 33902546DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • JIHYE HWANG, Professor

    Physical & Rehabilitation Medicine Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Range of motion
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

KR(2)