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Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT03883659
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wen-Hsu Sung, National Yang Ming University

Study Description
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Brief Summary:
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Other: Smartphone Other: traditional paper hangouts Not Applicable

Detailed Description:
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. The outcome measure including shoulder range of motion, pain condition, home exercise adherence and satisfaction of smartphone program
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: one assessor who don't know the group will measure the range of motion by using goniometer
Primary Purpose: Treatment
Official Title: Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: traditional paper hangouts group
patients use the traditional paper hangouts to conduct the home exercise program at home
 Other: traditional paper hangouts
patients with frozen shoulder in the smartphone group will use the paper hangouts to conduct the home exercise program. The content of the paper hangouts were description of the home exercise.
Experimental: smartphone group
patients use the smartphone to conduct the home exercise program at home
 Other: Smartphone
patients with frozen shoulder in the smartphone group will use the smartphone to conduct the home exercise program. The patients will be asked to follow the description to have mobility assessment at least 1 week and do the individualized exercise themselves.


Outcome Measures
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Primary Outcome Measures :
  1. home exercise adherence [ Time Frame: 4 weeks ]
    the days patients do the home exercise program


Secondary Outcome Measures :
  1. shoulder range of motion [ Time Frame: baseline, 4 weeks ]
    the mobility of shoulder

  2. Visual analog scale (VAS) [ Time Frame: baseline, 4 weeks ]
    Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful

  3. System usability scale (SUS) [ Time Frame: 4 weeks ]
    the satisfaction scale of the smartphone program


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gradual shoulder pain and stiffness at least 4 months
  • loss of active and passive shoulder mobility, shoulder external rotation <45 degree
  • ability to use the smartphone

Exclusion Criteria:

  • normal shoulder mobility
  • diagnostic shoulder osteoarthritis
  • nerve pain
  • injection of corticosteroids in 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883659


Locations
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Taiwan
Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 11490
Yang Ming university
Taipei, Taiwan
Sponsors and Collaborators
National Yang Ming University
Investigators
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Principal Investigator: Wen-Hsu Sung, PhD Principal Investigator
More Information
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Responsible Party: Wen-Hsu Sung, Associate Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03883659    
Other Study ID Numbers: FStraining
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-Hsu Sung, National Yang Ming University:
frozen shoulder
smartphone
home exercise program
range of motion
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases