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Completed

NCT Number: NCT04316130

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

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.

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Key information

Conditions

Frozen Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Seoul, Gangnam-gu, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uincare Homeplus

Device

Interactive digital healthcare system

Other names: digital healthcare

brochure

Other

Brochure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Ministry of Health, Republic of Korea

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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