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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04619940
Other study ID # IMU Shoulder
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2019

Study information

Verified date November 2020
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 1, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.
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.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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