SpineNCT07510503
The Use of Two Different Smartphone Applications in Measuring
An observational study of Spine, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will include healthy volunteers aged 18-25 years. Demographic information will be recorded, and an experienced physiotherapist will mark five reference points on the spine of the participants, starting from the cervical spine and extending to the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2026to 30 Apr 2026
- Phase
- Observational
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy older individuals
Who may be able to join
- Being over 18 years of age,
- being able to stand and walk without an assistive device,
- not having experienced back pain or lower extremity pain in the last 6 months,
- and being willing to participate in the study.
Who cannot join
- Lack of consent,
- lower extremity injuries (dislocation, sprain) within one month prior to measurement,
- lower extremity fractures within the last 6 months,
- tactile sensitivity that prevents the adoption of a free and habitual posture.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran Üniversitesi
Kırşehir, 40100
About this study
Official title: An Investigation of the Intra- and Inter-Rater Reliability of Two Different Smartphone Applications Used in the Measurement of Sagittal Spinal Curvature
This study will include healthy volunteers aged 18-25 years. Demographic information will be recorded, and an experienced physiotherapist will mark five reference points on the spine of the participants, starting from the cervical spine and extending to the lumbar spine. Angle measurements will then be taken from these five reference points using a gravity inclinometer, an Android smartphone, and an iOS phone. Measurements will be repeated twice on the same day and twice again 24-48 hours later using three different devices. The accuracy and similarity of the measurements taken with these three devices will then be compared.
Read the detailed description
This study is designed as an observational, methodological study to investigate the intra-rater and inter-rater reliability and concurrent validity of two smartphone-based inclinometer applications used for sagittal spinal curvature assessment.
The study will include healthy volunteers aged 18-25 years. Participants will be informed about the study procedures, and written informed consent will be obtained before enrollment. Demographic and anthropometric characteristics, including age, sex, height, body weight, and body mass index, will be recorded.
Measurement Procedures An experienced physiotherapist will identify and mark five anatomical reference points along the spine, extending from the cervical region to the lumbosacral region. These reference points will be used to standardize the measurement locations across devices and assessment sessions.
Sagittal spinal inclination angles will be measured using three different devices:
A conventional gravity-based bubble inclinometer. An Android smartphone equipped with an inclinometer application. An iOS smartphone equipped with an inclinometer application. Measurements will be performed at the same anatomical reference points using all three devices. The conventional inclinometer will serve as a reference instrument for evaluating the concurrent validity of the smartphone applications.
Reliability Assessment To evaluate intra-rater and inter-rater reliability, measurements will be performed by three assessors using a standardized assessment protocol.
Each measurement will be repeated twice during the initial assessment session. A second assessment session will be conducted 24-48 hours after the first session, during which the measurements will be repeated using the same three devices.
The repeated measurements will allow the evaluation of within-assessor consistency, agreement between different assessors, and measurement stability across assessment sessions.
Concurrent Validity Assessment The measurements obtained from the Android and iOS smartphone applications will be compared with those obtained using the conventional bubble inclinometer.
The agreement between the smartphone applications and the conventional inclinometer will be examined to determine whether smartphone-based measurements provide comparable results for sagittal spinal inclination assessment.
Statistical Analysis Descriptive statistics will be used to summarize participant characteristics and measurement results.
Intraclass correlation coefficients (ICCs) will be calculated to evaluate intra-rater reliability, inter-rater reliability, and test-retest reliability. Measurement error will be examined using the standard error of measurement (SEM) and minimal detectable change (MDC).
Concurrent validity will be assessed through correlation and agreement analyses. Pearson correlation coefficients, Lin's concordance correlation coefficients, and Bland-Altman analyses will be used to investigate the relationships, concordance, and systematic differences between measurements obtained using the smartphone applications and the conventional inclinometer.
Expected Contribution The study aims to provide evidence regarding the reliability and concurrent validity of smartphone-based inclinometer applications for assessing sagittal spinal inclination. The findings may help determine the potential clinical applicability of smartphone-based measurement tools in physiotherapy and rehabilitation assessments.
- Conditions
- Spine
- Keywords
- spine, inclinometer, smartphone
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Spinal Curvature
Description: The following 5 parameters were used for the measurement: 1. ALPHA 1 angle of sacrum (upper beam of the inclinometer, in the middle of the intervertebral space, on the line connecting the posterior superior iliac crests). 2. ALPHA 2 angle - sacrolumbar junction S/L (center of the inclinometer on the line connecting the posterior superior iliac crests). 3. BETA angle - Th12-L1 thoracolumbar junction (center of the inclinometer at the thoracolumbar junction). 4. GAMMA angle - C7-Th1 (center of the inclinometer on C7). 5. DELTA angle - Th3-Th4 (upper beam of the inclinometer at the height of the upper angle of the scapula).
Measured: Two measurements taken 10 minutes apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start14 Mar 2026
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra BAYRAMOĞLU DEMİRDÖĞEN, Ahi Evran University Education and Research Hospital
- Investigators
- Esra BAYRAMOĞLU DEMİRDÖĞEN, Principal investigator, Kırşehir Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510503
- Sponsor's protocol ID
- KAEU-EBAYRAMOGLUD-006
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Intra- and Inter-Rater Reliability of Two Different Smartphone Applications Used in the Measurement of Sagittal Spinal Curvature
- ClinicalTrials.gov ID
- NCT07510503
- Acronym / sponsor ID
- KAEU-EBAYRAMOGLUD-006
- Conditions
- Spine
- Keywords
- spine, inclinometer, smartphone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Apr 2026 (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.
This study will include healthy volunteers aged 18-25 years. Demographic information will be recorded, and an experienced physiotherapist will mark five reference points on the spine of the participants, starting from the cervical spine and extending to the lumbar spine. Angle measurements will then be taken from these five reference points using a gravity inclinometer, an Android smartphone, and an iOS phone. Measurements will be repeated twice on the same day and twice again 24-48 hours later using three different devices. The accuracy and similarity of the measurements taken with these three devices will then be compared.
Detailed description
This study is designed as an observational, methodological study to investigate the intra-rater and inter-rater reliability and concurrent validity of two smartphone-based inclinometer applications used for sagittal spinal curvature assessment.
The study will include healthy volunteers aged 18-25 years. Participants will be informed about the study procedures, and written informed consent will be obtained before enrollment. Demographic and anthropometric characteristics, including age, sex, height, body weight, and body mass index, will be recorded.
Measurement Procedures An experienced physiotherapist will identify and mark five anatomical reference points along the spine, extending from the cervical region to the lumbosacral region. These reference points will be used to standardize the measurement locations across devices and assessment sessions.
Sagittal spinal inclination angles will be measured using three different devices:
A conventional gravity-based bubble inclinometer. An Android smartphone equipped with an inclinometer application. An iOS smartphone equipped with an inclinometer application. Measurements will be performed at the same anatomical reference points using all three devices. The conventional inclinometer will serve as a reference instrument for evaluating the concurrent validity of the smartphone applications.
Reliability Assessment To evaluate intra-rater and inter-rater reliability, measurements will be performed by three assessors using a standardized assessment protocol.
Each measurement will be repeated twice during the initial assessment session. A second assessment session will be conducted 24-48 hours after the first session, during which the measurements will be repeated using the same three devices.
The repeated measurements will allow the evaluation of within-assessor consistency, agreement between different assessors, and measurement stability across assessment sessions.
Concurrent Validity Assessment The measurements obtained from the Android and iOS smartphone applications will be compared with those obtained using the conventional bubble inclinometer.
The agreement between the smartphone applications and the conventional inclinometer will be examined to determine whether smartphone-based measurements provide comparable results for sagittal spinal inclination assessment.
Statistical Analysis Descriptive statistics will be used to summarize participant characteristics and measurement results.
Intraclass correlation coefficients (ICCs) will be calculated to evaluate intra-rater reliability, inter-rater reliability, and test-retest reliability. Measurement error will be examined using the standard error of measurement (SEM) and minimal detectable change (MDC).
Concurrent validity will be assessed through correlation and agreement analyses. Pearson correlation coefficients, Lin's concordance correlation coefficients, and Bland-Altman analyses will be used to investigate the relationships, concordance, and systematic differences between measurements obtained using the smartphone applications and the conventional inclinometer.
Expected Contribution The study aims to provide evidence regarding the reliability and concurrent validity of smartphone-based inclinometer applications for assessing sagittal spinal inclination. The findings may help determine the potential clinical applicability of smartphone-based measurement tools in physiotherapy and rehabilitation assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy older individuals
Key inclusion criteria (4 listed)
- Being over 18 years of age,
- being able to stand and walk without an assistive device,
- not having experienced back pain or lower extremity pain in the last 6 months,
- and being willing to participate in the study.
Key exclusion criteria (4 listed)
- Lack of consent,
- lower extremity injuries (dislocation, sprain) within one month prior to measurement,
- lower extremity fractures within the last 6 months,
- tactile sensitivity that prevents the adoption of a free and habitual posture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Spinal Curvature
Time frame: Two measurements taken 10 minutes apart.
Description: The following 5 parameters were used for the measurement: 1. ALPHA 1 angle of sacrum (upper beam of the inclinometer, in the middle of the intervertebral space, on the line connecting the posterior superior iliac crests). 2. ALPHA 2 angle - sacrolumbar junction S/L (center of the inclinometer on the line connecting the posterior superior iliac crests). 3. BETA angle - Th12-L1 thoracolumbar junction (center of the inclinometer at the thoracolumbar junction). 4. GAMMA angle - C7-Th1 (center of the inclinometer on C7). 5. DELTA angle - Th3-Th4 (upper beam of the inclinometer at the height of the upper angle of the scapula).
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 24 Sep 2026.
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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.
Esra BAYRAMOĞLU DEMİRDÖĞEN principal investigator
Kırşehir Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine, run by Ahi Evran University Education and Research Hospital 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 4 inclusion and 4 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 24 Sep 2026. 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?
Assessment of Spinal Curvature (time frame: Two measurements taken 10 minutes apart.). 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 24 Sep 2026.