Reliability and ValidityNCT04787900
Reliability and Validity of iPhone Application for OBER
A study testing iPhone measurement application and Bubble inclinometer in people with Reliability and Validity and Smartphone, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The validity and reliability of adduction angle measurement of hip with smartphone will be investigate. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Reliability and Validity, Smartphone, Iliotibial Band Syndrome
- What is being tested?
- iPhone measurement application and Bubble inclinometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 26 Apr 2021
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 20 and 45 and agreed to participate the study.
Who cannot join
- Having hip or knee surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Validity and Reliability of the iPhone® Measurement Application to Evaluate Iliotibial Band Length
The validity and reliability of adduction angle measurement of hip with smartphone will be investigate.
Read the detailed description
Our study is to investigate the intra-rater reliability, inter-rater reliability and concurrent validity of iPhone Measurement Applications to measure iliotibial band length in individuals without iliotibial band-related pathology. The aim of this study is to evaluate the intra-rater reliability, inter-rater reliability and concurrent validity of bubble inclinometer and iPhone Measurement Applications in the evaluation of iliotibial band tension in healthy individuals. This research is being done to determine if there are other more reliable, valid or innovative technological ways to measure iliotibial band length.
Participants:
A priori power analysis indicated that a minimum 16 or more participants should be enrolled the study for a correlation of 0.7, with an α level of .05 and power of 95%. The study protocol comply with the Declaration of Helsinki for Human Experimentation. Participants were excluded if they had hip or knee surgery in the past year and iliotibial band syndrome. All participants provide written informed consent. Permission for the study was obtained from KTO Karatay University Faculty of Medicine Drug and Non-Medical Device Research Ethics Committee with decision number 2019/012.
Two experienced physiotherapists will evaluate the elasticity of both the dominant and non-dominant iliotibial bands after 2 minutes of warm-up before the evaluation. Measurements will be made by two physical therapists for each participant in different rooms without seeing each other. The examiners will carry out three measurements for both extremities, using both the bubble inclinometer and the iPhone® measurement app. A 5-minute passive rest will be give between measurements. All evaluations will be first conducted by Examiner 1 and then by Examiner 2. Measurement values will be record by a third physiotherapist. Data obtained from both devices will be compare in terms of validity and reliability using statistical analysis used in previous studies.
All inclinometric measurements will be do by two independent blind examiners (B.S.U. and H.G.) and the range of motion (ROM) will be read directly from the devices by a third examiner.
Before the first measurement, the participant will be ask to warm up for five minutes. For the measurement, the participant will be ask to lie on his side and flex the knee to 90 degrees. The examiner will stabilize the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 will be record the result by placing the device to be measured on the lateral projection of the midpoint of the femur. By preserving the participant's position, measurements will be make with the other device immediately and the values will bw record by the Examiner3.
After the first measurement, second and third measurements will be take at 2-minute passive intervals.
After the participants will complete their first examiner evaluation, they will move to the second examiner's room. The same protocol will be use for all measurements by the Examiner 2.
Instruments We will use 2 devices to measure iliotibial band length; bubble inclinometer (Baseline, Fabrication Enterprises Inc., New York) and iPhone® Measurement Applications (Apple Inc, California). The iPhone® Measurement Applications measurements will make with the iPhone 6s plus running IOS 13.3.1 (Apple Inc, California).
- Being tested
- iPhone measurement application, Bubble inclinometer
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPhone measurement applicationDevice
The iPhone measurement application will be used to ensure validity and reliability.
Bubble inclinometerDevice
Bubble inclinometer with proven validity and reliability will be used for this study.
| Study group | Role | What they receive |
|---|---|---|
| iPhone measurement application | Experimental | For the measurement, the participant was asked to lie on his side and flex the knee to 90 degrees. The examiner stabilized the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 recorded the result by placing the device to be measured on the lateral projection of the midpoint of the femur. Receives: Device: iPhone measurement application |
| Bubble inclinometer | Active comparator | measurement will be done by the same method. For the measurement, the participant was asked to lie on his side and flex the knee to 90 degrees. The examiner stabilized the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 recorded the result by placing the device to be measured on the lateral projection of the midpoint of the femur. Receives: Device: Bubble inclinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
iPhone Measurement Application
Iliotibial band length of the participants will be measured with the iPhone Measurement Application
Measured: 3 weeks
Secondary outcomes (1)
Bubble inclinometer
Iliotibial band length of the participants will be measured with the Bubble inclinometer
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start8 Mar 2021
- Primary completion24 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reliability and ValidityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- wo experienced physiotherapists will evaluate the elasticity of both the dominant and non-dominant iliotibial bands after 2 minutes of warm-up before the evaluation. Measurements will be made by two physical therapists for each participant in different rooms without seeing each other. The examiners will carry out three measurements for both extremities, using both the bubble inclinometer and the iPhone® measurement app. A 5-minute passive rest will be give between measurements. All evaluations will be first conducted by Examiner 1 and then by Examiner 2. Measurement values will be record by a third physiotherapist. Data obtained from both devices will be compare in terms of validity and reliability using statistical analysis used in previous studies.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787900
- Sponsor's protocol ID
- KaratayUSonmezOber
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Validity and Reliability of the iPhone® Measurement Application to Evaluate Iliotibial Band Length
- ClinicalTrials.gov ID
- NCT04787900
- Acronym / sponsor ID
- KaratayUSonmezOber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 9 Mar 2021 (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 adduction angle measurement of hip with smartphone will be investigate.
Detailed description
Our study is to investigate the intra-rater reliability, inter-rater reliability and concurrent validity of iPhone Measurement Applications to measure iliotibial band length in individuals without iliotibial band-related pathology. The aim of this study is to evaluate the intra-rater reliability, inter-rater reliability and concurrent validity of bubble inclinometer and iPhone Measurement Applications in the evaluation of iliotibial band tension in healthy individuals. This research is being done to determine if there are other more reliable, valid or innovative technological ways to measure iliotibial band length.
Participants:
A priori power analysis indicated that a minimum 16 or more participants should be enrolled the study for a correlation of 0.7, with an α level of .05 and power of 95%. The study protocol comply with the Declaration of Helsinki for Human Experimentation. Participants were excluded if they had hip or knee surgery in the past year and iliotibial band syndrome. All participants provide written informed consent. Permission for the study was obtained from KTO Karatay University Faculty of Medicine Drug and Non-Medical Device Research Ethics Committee with decision number 2019/012.
Two experienced physiotherapists will evaluate the elasticity of both the dominant and non-dominant iliotibial bands after 2 minutes of warm-up before the evaluation. Measurements will be made by two physical therapists for each participant in different rooms without seeing each other. The examiners will carry out three measurements for both extremities, using both the bubble inclinometer and the iPhone® measurement app. A 5-minute passive rest will be give between measurements. All evaluations will be first conducted by Examiner 1 and then by Examiner 2. Measurement values will be record by a third physiotherapist. Data obtained from both devices will be compare in terms of validity and reliability using statistical analysis used in previous studies.
All inclinometric measurements will be do by two independent blind examiners (B.S.U. and H.G.) and the range of motion (ROM) will be read directly from the devices by a third examiner.
Before the first measurement, the participant will be ask to warm up for five minutes. For the measurement, the participant will be ask to lie on his side and flex the knee to 90 degrees. The examiner will stabilize the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 will be record the result by placing the device to be measured on the lateral projection of the midpoint of the femur. By preserving the participant's position, measurements will be make with the other device immediately and the values will bw record by the Examiner3.
After the first measurement, second and third measurements will be take at 2-minute passive intervals.
After the participants will complete their first examiner evaluation, they will move to the second examiner's room. The same protocol will be use for all measurements by the Examiner 2.
Instruments We will use 2 devices to measure iliotibial band length; bubble inclinometer (Baseline, Fabrication Enterprises Inc., New York) and iPhone® Measurement Applications (Apple Inc, California). The iPhone® Measurement Applications measurements will make with the iPhone 6s plus running IOS 13.3.1 (Apple Inc, California).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- wo experienced physiotherapists will evaluate the elasticity of both the dominant and non-dominant iliotibial bands after 2 minutes of warm-up before the evaluation. Measurements will be made by two physical therapists for each participant in different rooms without seeing each other. The examiners will carry out three measurements for both extremities, using both the bubble inclinometer and the iPhone® measurement app. A 5-minute passive rest will be give between measurements. All evaluations will be first conducted by Examiner 1 and then by Examiner 2. Measurement values will be record by a third physiotherapist. Data obtained from both devices will be compare in terms of validity and reliability using statistical analysis used in previous studies.
| Arm | Type | Receives |
|---|---|---|
| iPhone measurement application | Experimental | Device: iPhone measurement applicationFor the measurement, the participant was asked to lie on his side and flex the knee to 90 degrees. The examiner stabilized the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 recorded the result by placing the device to be measured on the lateral projection of the midpoint of the femur. |
| Bubble inclinometer | Active comparator | Device: Bubble inclinometermeasurement will be done by the same method. For the measurement, the participant was asked to lie on his side and flex the knee to 90 degrees. The examiner stabilized the patient from the pelvis with one hand, and with the other hand brought the flexed leg of the participant to abduction and extension. The Examiner 3 recorded the result by placing the device to be measured on the lateral projection of the midpoint of the femur. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being between the ages of 20 and 45 and agreed to participate the study.
Key exclusion criteria (1 listed)
- Having hip or knee surgery
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 |
|---|---|---|
| iPhone measurement applicationThe iPhone measurement application will be used to ensure validity and reliability. | Device | iPhone measurement application |
| Bubble inclinometerBubble inclinometer with proven validity and reliability will be used for this study. | Device | Bubble inclinometer |
Primary outcome
iPhone Measurement Application
Time frame: 3 weeks
Iliotibial band length of the participants will be measured with the iPhone Measurement Application
1 secondary outcome
Bubble inclinometer
Time frame: 3 weeks
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 8 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Reliability and Validity
Not yet recruitingObservational study
Development of a Body Hygiene Assessment Scale for Bedbound Individuals
Body Hygiene Status in Bedbound Individuals
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Night Pain Module for Rotator Cuff-Related Shoulder Pain
Shoulder Pain, Rotator Cuff Related Shoulder Pain
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
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 iPhone measurement application and Bubble inclinometer in people with Reliability and Validity and Smartphone, run by KTO Karatay 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 1 inclusion and 1 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 8 Sep 2021. 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?
iPhone Measurement Application (time frame: 3 weeks). 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 8 Sep 2021.