Validity and Reliability of iPhone Application in Internal Rotation Measurement

NCT ID: NCT04619940

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-01-01

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

iHandy application

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.

Group Type: EXPERIMENTAL

iHandy application

Intervention Type: DIAGNOSTIC_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 Goniometer

Intervention Type: DIAGNOSTIC_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 goniometer

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.

Group Type: ACTIVE_COMPARATOR

iHandy application

Intervention Type: DIAGNOSTIC_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 Goniometer

Intervention Type: DIAGNOSTIC_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.

Interventions

iHandy application

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

Standard Goniometer

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Bilinç Doğruöz Karatekin

MD, Specialist of PMR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IMU Shoulder

Identifier Type: -

Identifier Source: org_study_id