Back to resultsSmartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Primary Purpose
Frozen Shoulder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Smartphone
traditional paper hangouts
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder focused on measuring frozen shoulder, smartphone, home exercise program, range of motion
Eligibility 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
Sites / Locations
- Tri-Service General Hospital
- Yang Ming university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
traditional paper hangouts group
smartphone group
Arm Description
patients use the traditional paper hangouts to conduct the home exercise program at home
patients use the smartphone to conduct the home exercise program at home
Outcomes
Primary Outcome Measures
home exercise adherence
the days patients do the home exercise program
Secondary Outcome Measures
shoulder range of motion
the mobility of shoulder
Visual analog scale (VAS)
Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful
System usability scale (SUS)
the satisfaction scale of the smartphone program
Full Information
NCT ID
NCT03883659
First Posted
March 18, 2019
Last Updated
August 21, 2019
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT03883659
Brief Title
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Official Title
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
frozen shoulder, smartphone, home exercise program, range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Masking Description
one assessor who don't know the group will measure the range of motion by using goniometer
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional paper hangouts group
Arm Type
Active Comparator
Arm Description
patients use the traditional paper hangouts to conduct the home exercise program at home
Arm Title
smartphone group
Arm Type
Experimental
Arm Description
patients use the smartphone to conduct the home exercise program at home
Intervention Type
Other
Intervention Name(s)
Smartphone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional paper hangouts
Intervention Description
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.
Primary Outcome Measure Information:
Title
home exercise adherence
Description
the days patients do the home exercise program
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
shoulder range of motion
Description
the mobility of shoulder
Time Frame
baseline, 4 weeks
Title
Visual analog scale (VAS)
Description
Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful
Time Frame
baseline, 4 weeks
Title
System usability scale (SUS)
Description
the satisfaction scale of the smartphone program
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Hsu Sung, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Yang Ming university
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
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