NCT04316130

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

Completed NA Last updated 4 January 2022

What this trial tests

NA trial testing Uincare Homeplus in Frozen Shoulder in 100 participants. Completed in 31 December 2021.

Timeline

1 March 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Samsung Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 March 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	2 locations across South Korea

Drugs / interventions tested

• Uincare Homeplus
• Brochure

Conditions studied

• Frozen Shoulder — all drugs for Frozen Shoulder →

Sponsor

Samsung Medical Center

Who can join

19 and older, any sex, with Frozen Shoulder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial.
   Yeo SM, Lim JY, Do JG, Lim JY, et al · · 2021 · cited 18× · PMID 33902546 · DOI 10.1186/s12891-021-04261-1
2. Effects of augmented reality-based telerehabilitation in adhesive capsulitis of the shoulder: a randomized controlled trial.
   Yeo SM, Lim JY, Kim S, Park HY, et al · · 2025 · PMID 40580799 · DOI 10.1016/j.rehab.2025.101956