- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619940
Validity and Reliability of iPhone Application in Internal Rotation Measurement
Validity and Reliability of iPhone Application in Active Internal Rotation Measurement of Shoulder in Patients With Shoulder Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34732
- Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
ACTIVE_COMPARATOR: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iHandy application
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMU Shoulder
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Pain
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg Municipality and other collaboratorsCompletedHypermobility Syndrome Shoulder | Shoulder Pain Chronic | Shoulder LuxationDenmark
-
Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder
-
Oslo University HospitalUnknownShoulder Impingement Syndrome | Subacromial Shoulder PainNorway
-
Istanbul University - Cerrahpasa (IUC)Istanbul Aydın UniversityCompletedPain, Shoulder | Myofacial Pain | Adhesion; ShoulderTurkey
-
Mohamed R El TahanCompletedUnilateral Chronic Shoulder Pain | Bilateral Chronic Shoulder PainEgypt
-
Hasan Kalyoncu UniversityHacettepe UniversityCompletedShoulder Pain | Shoulder Injury | Shoulder ImpingementTurkey
-
Makassed General HospitalRecruiting
-
Zagazig UniversityCompleted
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Injuries | Shoulder Pain | Shoulder Capsulitis | Frozen Shoulder | Shoulder ImpingementPakistan
Clinical Trials on iHandy application
-
Universidad Católica San Antonio de MurciaNot yet recruitingPhysical Activity | Adolescent Behavior | New Technologies
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Vanderbilt... and other collaboratorsActive, not recruitingNephrectomy | Kidney | Living DonorsUnited States
-
Assiut UniversityCompletedImproving Quality of LifeEgypt
-
Ataturk Training and Research HospitalNot yet recruiting
-
TC Erciyes UniversityCompleted
-
patientMpower Ltd.Health Service Executive, IrelandCompleted
-
Kars State HospitalCompletedExercise | Ultrasound | KinesiotapeTurkey
-
The University of Hong KongCompletedEarly Childhood CariesHong Kong
-
University of North Carolina, Chapel HillCompleted