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

August 21, 2019 updated by: Wen-Hsu Sung, National Yang Ming University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

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

  • Taiwan
      • Taipei, Taiwan
        • Yang Ming university
    • Neihu District
      • Taipei, Neihu District, Taiwan, 11490
        • Tri-Service General Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
home exercise adherence
Time Frame: 4 weeks
the days patients do the home exercise program
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder range of motion
Time Frame: baseline, 4 weeks
the mobility of shoulder
baseline, 4 weeks
Visual analog scale (VAS)
Time Frame: baseline, 4 weeks
Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful
baseline, 4 weeks
System usability scale (SUS)
Time Frame: 4 weeks
the satisfaction scale of the smartphone program
4 weeks

Collaborators and Investigators

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

Sponsor

National Yang Ming University

Investigators

  • Principal Investigator: Wen-Hsu Sung, PhD, Principal Investigator

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)

April 1, 2019

Primary Completion (Actual)

July 3, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FStraining

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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