Shoulder PainNCT04619940
Validity and Reliability of iPhone Application in Internal Rotation Measurement
A study testing iHandy application and Standard Goniometer in people with Shoulder Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The validity and reliability of active internal rotation ROM measurement of shoulder with smartphone in patients with shoulder pain was investigated. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- iHandy application and Standard Goniometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with shoulder pain
- 40-70 years old
- Agreed to participate the study
Who cannot join
- <40 years old or >70 years old
- Not agreed to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
About this study
Official title: Validity and Reliability of iPhone Application in Active Internal Rotation Measurement of Shoulder in Patients With Shoulder Pain
The validity and reliability of active internal rotation ROM measurement of shoulder with smartphone in patients with shoulder pain was investigated.
Read the 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
- Being tested
- iHandy application, Standard Goniometer
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: iHandy application; Diagnostic 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. Receives: Diagnostic Test: iHandy application; Diagnostic Test: Standard Goniometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jan 2018
- Primary completion1 Jul 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619940
- Sponsor's protocol ID
- IMU Shoulder
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of iPhone Application in Active Internal Rotation Measurement of Shoulder in Patients With Shoulder Pain
- ClinicalTrials.gov ID
- NCT04619940
- Acronym / sponsor ID
- IMU Shoulder
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| iHandy application | Experimental | Diagnostic Test: iHandy application, Diagnostic Test: Standard GoniometerThe 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 | Active comparator | Diagnostic Test: iHandy application, Diagnostic Test: Standard GoniometerWhile 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with shoulder pain
- 40-70 years old
- Agreed to participate the study
Key exclusion criteria (2 listed)
- <40 years old or >70 years old
- Not agreed to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iHandy applicationThe 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 | Standard goniometer, iHandy application |
| Standard GoniometerWhile 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 | Standard goniometer, iHandy application |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iHandy application and Standard Goniometer in people with Shoulder Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iHandy application (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.