NCT04619940

Brief Summary

The validity and reliability of active internal rotation ROM measurement of shoulder with smartphone in patients with shoulder pain was investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

October 29, 2020

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • iHandy application

    The IHandy® app is a free app with a visual display similar to that of the digital inclinometer. In the measurement made with the application, the phone was held parallel to the ulna and the value displayed on the screen was recorded as range of motion value.

    6 months

Study Arms (2)

iHandy application

EXPERIMENTAL

The IHandy® app is a free app with a visual display similar to that of the digital inclinometer in terms of digital size. In this study, due to its prevalence in the literature and its use in clinics, manual goniometer (gold standard) was chosen to be compared with this iPhone application.

Diagnostic Test: iHandy applicationDiagnostic Test: Standard Goniometer

Standard goniometer

ACTIVE COMPARATOR

While measuring with goniometer, the pivot point of the goniometer was placed on the olecranon, the immobile rod of the goniometer was kept parallel to the bed, while the moving rod was kept parallel to the ulna, the angle was recorded at the end point of the movement.

Diagnostic Test: iHandy applicationDiagnostic Test: Standard Goniometer

Interventions

iHandy applicationDIAGNOSTIC_TEST

The IHandy® app is a free app with a visual display similar to that of the digital inclinometer in terms of digital size. In this study, due to its prevalence in the literature and its use in clinics, manual goniometer (gold standard) was chosen to be compared with this iPhone application.

Standard goniometeriHandy application
Standard GoniometerDIAGNOSTIC_TEST

While measuring with goniometer, the pivot point of the goniometer was placed on the olecranon, the immobile rod of the goniometer was kept parallel to the bed, while the moving rod was kept parallel to the ulna, the angle was recorded at the end point of the movement.

Standard goniometeriHandy application

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with shoulder pain
  • years old
  • Agreed to participate the study

You may not qualify if:

  • \<40 years old or \>70 years old
  • Not agreed to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Measurements were conducted separately in different cabinets without seeing each other for each participant by 1 physical medicine and rehabilitation specialist and 1 physiotherapist. The measurements were recorded in separate locations until all participants were completed.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Measurements were conducted separately in different cabinets without seeing each other for each participant by 1 physical medicine and rehabilitation specialist and 1 physiotherapist. The measurements were recorded in separate locations until all participants were completed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Specialist of PMR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 6, 2020

Study Start

January 1, 2018

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations