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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • KTO Karatay University

    Konya, 42020

Other trials in Turkey (Türkiye)

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 groups in NCT04787900
Study groupRoleWhat they receive
iPhone measurement applicationExperimentalFor 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 inclinometerActive comparatormeasurement 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.

  1. iPhone Measurement Application

    Iliotibial band length of the participants will be measured with the iPhone Measurement Application

    Measured: 3 weeks

Secondary outcomes (1)
  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.

  1. First posted9 Mar 2021
  2. Study start8 Mar 2021
  3. Primary completion24 Apr 2021
  4. Study completion26 Apr 2021

Resources

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)
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

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.

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