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

January 2, 2022 updated by: JiHye Hwang, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 06591
        • Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise using Uincare Homeplus
Uincare Homeplus
Device: Uincare Homeplus
Interactive digital healthcare system
Other Names:
  • digital healthcare
Active Comparator: Exercise using brochure
brochure
Other: Brochure
Brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM) in affected shoulder
Time Frame: 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
Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Numerical rating scale (NRS) of affected shoulder
Time Frame: 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.
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)
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Quality of life in the patients with frozen shoulder using EQ-5D-5L
Time Frame: 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.
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)
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Ministry of Health, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 2, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2019-05-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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