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

NCT03883659 | Completed

• 1 other identifier: FStraining
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Frozen Shoulder

Keywords

frozen shoulder; smartphone; home exercise program; range of motion

Outcome Measures

Primary Outcomes (1)

• home exercise adherence

  the days patients do the home exercise program

  4 weeks

Secondary Outcomes (3)

• shoulder range of motion

  baseline, 4 weeks

• Visual analog scale (VAS)

  baseline, 4 weeks

• System usability scale (SUS)

  4 weeks

Study Arms (2)

traditional paper hangouts group

ACTIVE COMPARATOR

patients use the traditional paper hangouts to conduct the home exercise program at home

Other: traditional paper hangouts

smartphone group

EXPERIMENTAL

patients use the smartphone to conduct the home exercise program at home

Other: Smartphone

Interventions

Smartphone OTHER

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.

smartphone group

traditional paper hangouts OTHER

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.

traditional paper hangouts group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• normal shoulder mobility
• diagnostic shoulder osteoarthritis
• nerve pain
• injection of corticosteroids in 3 months

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (2)

Tri-Service General Hospital

Taipei, Neihu District, 11490, Taiwan

Location

Yang Ming university

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Wen-Hsu Sung, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: one assessor who don't know the group will measure the range of motion by using goniometer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 30, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)