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

Samsung Medical Center logo

Samsung Medical Center

Status

Completed

Conditions

Frozen Shoulder

Treatments

Device: Uincare Homeplus
Other: Brochure

Study type

Interventional

Funder types

Other

Identifiers

NCT04316130
SMC-2019-05-021

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Exercise using Uincare Homeplus
Experimental group
Description:
Uincare Homeplus
Treatment:
Device: Uincare Homeplus
Exercise using brochure
Active Comparator group
Description:
brochure
Treatment:
Other: Brochure

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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