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Reliability and Validity of iPhone Application for OBER

Primary Purpose

Reliability and Validity, Smartphone, Iliotibial Band Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
iPhone measurement application
Bubble inclinometer
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Reliability and Validity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being between the ages of 20 and 45 and agreed to participate the study.

Exclusion Criteria:

  • Having hip or knee surgery

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPhone measurement application

Bubble inclinometer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bubble inclinometer
Iliotibial band length of the participants will be measured with the Bubble inclinometer

Full Information

First Posted
March 4, 2021
Last Updated
September 7, 2021
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04787900
Brief Title
Reliability and Validity of iPhone Application for OBER
Official Title
Concurrent Validity and Reliability of the iPhone® Measurement Application to Evaluate Iliotibial Band Length
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
April 24, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reliability and Validity, Smartphone, Iliotibial Band Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPhone measurement application
Arm Type
Experimental
Arm Description
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.
Arm Title
Bubble inclinometer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iPhone measurement application
Intervention Description
The iPhone measurement application will be used to ensure validity and reliability.
Intervention Type
Device
Intervention Name(s)
Bubble inclinometer
Intervention Description
Bubble inclinometer with proven validity and reliability will be used for this study.
Primary Outcome Measure Information:
Title
iPhone Measurement Application
Description
Iliotibial band length of the participants will be measured with the iPhone Measurement Application
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Bubble inclinometer
Description
Iliotibial band length of the participants will be measured with the Bubble inclinometer
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being between the ages of 20 and 45 and agreed to participate the study. Exclusion Criteria: Having hip or knee surgery
Facility Information:
Facility Name
KTO Karatay University
City
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Reliability and Validity of iPhone Application for OBER

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