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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03883659
Other study ID # FStraining
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date July 30, 2019

Study information

Verified date August 2019
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date July 30, 2019
Est. primary completion date July 3, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Taiwan Tri-Service General Hospital Taipei Neihu District
Taiwan Yang Ming university Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary home exercise adherence the days patients do the home exercise program 4 weeks
Secondary shoulder range of motion the mobility of shoulder baseline, 4 weeks
Secondary Visual analog scale (VAS) Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful baseline, 4 weeks
Secondary System usability scale (SUS) the satisfaction scale of the smartphone program 4 weeks
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