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Validity and Reliability of iPhone Application in Internal Rotation Measurement

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
iHandy application
Standard Goniometer
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Pain

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with shoulder pain
  • 40-70 years old
  • Agreed to participate the study

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iHandy application

Standard goniometer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2020
Last Updated
November 3, 2020
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04619940
Brief Title
Validity and Reliability of iPhone Application in Internal Rotation Measurement
Official Title
Validity and Reliability of iPhone Application in Active Internal Rotation Measurement of Shoulder in Patients With Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The validity and reliability of active internal rotation ROM measurement of shoulder with smartphone in patients with shoulder pain was investigated.
Detailed Description
Eighteen patients with shoulder pain who applied to the Physical Medicine and Rehabilitation, shoulder subspecialty outpatient clinic who agreed to participate in the study and 18 volunteers who had not experienced shoulder pain before enrolled in the study. Participant age range was determined as 40-70 years. 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. The participants were asked to lie on the bed in supine position with shoulder to be measured at the edge of the bed. The measured shoulder was positioned at 90 degrees abduction, 90 degrees elbow flexion and forearm at neutral position. The participant was asked to bring the wrist closer to the bed in the direction of the little finger, and was measured at the angle that the shoulder could not move without lifting the arm. In the measurement made with the application, the phone was held parallel to the ulna and the value displayed on the screen was recorded. The participant were asked to repeat the movement if his/her shoulder lift up of bed, straightened his/her elbow, or did anything that would disrupt her movement pattern. Each measurement was repeated 3 times and after 2 weeks the control measurements were made by repeating 3 times. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iHandy application
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard goniometer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
iHandy application
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Goniometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
iHandy application
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with shoulder pain 40-70 years old Agreed to participate the study Exclusion Criteria: <40 years old or >70 years old Not agreed to participate
Facility Information:
Facility Name
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Validity and Reliability of iPhone Application in Internal Rotation Measurement

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