Lumbar Pain SyndromeNCT07680231
Smartphone Versus Back Range of Motion: Validity and Reliability in Lumbar Range of Motion Assessment
An observational study of Lumbar Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the clinimetric properties of the iPhone Level application as a suitable alternative to the Back Range of Motion device in assessing lumbar range of motion, including flexion, extension, and lateral flexion. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lumbar Pain Syndrome
- What is being tested?
- easement tool 1 - BROM device and Measurement tool 2 - iPhone level application
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 12 May 2026
- How long will I take part?
- 1 Day
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy University Students with normal BMI Healthy Male university students
Who may be able to join
- Age 18-25 years old
- Healthy Male university students
- All participants have normal BMI
Who cannot join
- Recent back, pelvic, or abdominal surgeries, traumatic injury to the back .
- Lower limb deformities, e.g., leg length discrepancy.
- Adolescent idiopathic scoliosis
- Any overweight or obese participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinimetric Properties of Smartphone Application as a Suitable Alternative to Back Range of Motion Device in Assessing the Back Range of Motion
This study aims to investigate the clinimetric properties of the iPhone Level application as a suitable alternative to the Back Range of Motion device in assessing lumbar range of motion, including flexion, extension, and lateral flexion.
Read the detailed description
Range of motion measurement is vital in physiotherapy for assessing deficits, establishing diagnoses, and planning interventions. Digital advancements now allow Range of motion assessment through devices and applications, such as the back range of motion, which is a gold standard for measuring lateral flexion due to its validity. Furthermore, studies indicate that the iPhone Level app effectively measures Range of motion in various joints, demonstrating good reliability and validity. This study aims to evaluate the reliability and concurrent validity of the iPhone Level application specifically for measuring lumbar flexion, extension, and side bending Range of motion.
- Conditions
- Lumbar Pain Syndrome
- Being tested
- easement tool 1 - BROM device, Measurement tool 2 - iPhone level application
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easement tool 1 - BROM deviceDevice
The BROM device consists of an inclinometer for measuring sagittal plane motions (flexion/extension) and a gravity goniometer/compass for lateral flexion. Participants stood upright with feet apart. Measurements were taken for flexion, extension, and bilateral lateral flexion. Three trials per movement were recorded and averaged.
Measurement tool 2 - iPhone level applicationDevice
The iPhone Level app was placed at T12-L1 and S1-S2 spinal levels. Lumbar flexion and extension ROM was calculated by subtracting S1-S2 angle from T12-L1 angle. For lateral flexion, the app was placed at T12 and S2 and the same subtraction method applied. Three trials per movement were recorded and averaged.
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of flexion and extension range of motion using inclinometer
During lumbar flexion and extension measurements using the Back Range of Motion (BROM) device, patients stand upright with extended knees and feet approximately 17 centimeters apart. For flexion, they bend forward to touch the floor, while for extension, they bend backward with crossed arms. An inclinometer is secured over the sacrum, and its position is centered to record readings in degrees. An L-shaped slide arm measures the distance between the T12 and S1 spinous processes. The device isolates lumbar motion from pelvic motion, and the stationary flexion/extension unit minimizes errors, enhancing measurement accuracy.
Measured: at baseline
assessment of lateral flexion range of motion using inclinometer
For measuring lumbar lateral flexion, the subject's sides are parallel to a wall to prevent compensatory forward trunk flexion. An inclinometer is secured over the sacral region at S1, using a belt for stability. A gravity goniometer is placed on the upper thoracic region to capture trunk angular displacement during side bending. The inclinometer is levelled and zeroed before movement, allowing for precise measurement of lateral lumbar movement while reducing thoracic and pelvic compensations. Accurate placement of the device is essential for reliable results. The subject slides their hand down the thigh, keeping weight on the opposite leg to ensure the measurement reflects true lateral flexion.measures]
Measured: at baseline
Secondary outcomes (2)
assessment of flexion and extension range of motion using smartphone
To measure lumbar flexion range of motion (ROM) using the iPhone Level app, participants are positioned standing upright with feet shoulder-width apart. T12-L1 and S1-S2 spinal levels are identified through palpation and marked on the skin. The iPhone is placed at these levels to record angles during maximum lumbar flexion. Total lumbar flexion ROM is calculated by subtracting the angle at S1-S2 from T12-L1. Subjects perform maximum lumbar flexion and extension with straight knees, and measurements are taken across three trials.
Measured: at baseline
assessment of lateral flexion range of motion using smartphone
During the measurement of lumbar side bending using the iPhone Level application, the subject will stand in a neutral upright position with feet shoulder-width apart and hands placed on the hips to prevent arm movement from influencing the measurement. The spinous processes of T12 and S2 are identified and marked on the skin. The iPhone is first placed and zeroed at the T12 level, and the subject is instructed to bend sideways (toward one side) as far as possible without lifting the heels or rotating the trunk. The device remains aligned at T12 to capture the angular displacement. The same procedure is repeated with the device positioned at S2, and the final lumbar side bending range of motion is calculated by subtracting the angle at S2 (pelvic movement) from that at T12 (trunk movement). This method isolates lumbar lateral flexion and has shown good reliability and validity in clinical settings
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- October University for Modern Sciences and Arts
- Responsible party
- Principal investigator, Loay Akmal Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680231
- Sponsor's protocol ID
- P.T.REC/012/006199
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 2 Jul 2026
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinimetric Properties of Smartphone Application as a Suitable Alternative to Back Range of Motion Device in Assessing the Back Range of Motion
- ClinicalTrials.gov ID
- NCT07680231
- Acronym / sponsor ID
- P.T.REC/012/006199
- Conditions
- Lumbar Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- October University for Modern Sciences and Arts
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 2 Jul 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 aims to investigate the clinimetric properties of the iPhone Level application as a suitable alternative to the Back Range of Motion device in assessing lumbar range of motion, including flexion, extension, and lateral flexion.
Detailed description
Range of motion measurement is vital in physiotherapy for assessing deficits, establishing diagnoses, and planning interventions. Digital advancements now allow Range of motion assessment through devices and applications, such as the back range of motion, which is a gold standard for measuring lateral flexion due to its validity. Furthermore, studies indicate that the iPhone Level app effectively measures Range of motion in various joints, demonstrating good reliability and validity. This study aims to evaluate the reliability and concurrent validity of the iPhone Level application specifically for measuring lumbar flexion, extension, and side bending Range of motion.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy University Students with normal BMI Healthy Male university students
Key inclusion criteria (3 listed)
- Age 18-25 years old
- Healthy Male university students
- All participants have normal BMI
Key exclusion criteria (4 listed)
- Recent back, pelvic, or abdominal surgeries, traumatic injury to the back .
- Lower limb deformities, e.g., leg length discrepancy.
- Adolescent idiopathic scoliosis
- Any overweight or obese participants
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 |
|---|---|---|
| easement tool 1 - BROM deviceThe BROM device consists of an inclinometer for measuring sagittal plane motions (flexion/extension) and a gravity goniometer/compass for lateral flexion. Participants stood upright with feet apart. Measurements were taken for flexion, extension, and bilateral lateral flexion. Three trials per movement were recorded and averaged. | Device | – |
| Measurement tool 2 - iPhone level applicationThe iPhone Level app was placed at T12-L1 and S1-S2 spinal levels. Lumbar flexion and extension ROM was calculated by subtracting S1-S2 angle from T12-L1 angle. For lateral flexion, the app was placed at T12 and S2 and the same subtraction method applied. Three trials per movement were recorded and averaged. | Device | – |
Primary outcome
assessment of flexion and extension range of motion using inclinometer
Time frame: at baseline
During lumbar flexion and extension measurements using the Back Range of Motion (BROM) device, patients stand upright with extended knees and feet approximately 17 centimeters apart. For flexion, they bend forward to touch the floor, while for extension, they bend backward with crossed arms. An inclinometer is secured over the sacrum, and its position is centered to record readings in degrees. An L-shaped slide arm measures the distance between the T12 and S1 spinous processes. The device isolates lumbar motion from pelvic motion, and the stationary flexion/extension unit minimizes errors, enhancing measurement accuracy.
assessment of lateral flexion range of motion using inclinometer
Time frame: at baseline
For measuring lumbar lateral flexion, the subject's sides are parallel to a wall to prevent compensatory forward trunk flexion. An inclinometer is secured over the sacral region at S1, using a belt for stability. A gravity goniometer is placed on the upper thoracic region to capture trunk angular displacement during side bending. The inclinometer is levelled and zeroed before movement, allowing for precise measurement of lateral lumbar movement while reducing thoracic and pelvic compensations. Accurate placement of the device is essential for reliable results. The subject slides their hand down the thigh, keeping weight on the opposite leg to ensure the measurement reflects true lateral flexion.measures]
2 secondary outcomes
assessment of flexion and extension range of motion using smartphone
Time frame: at baseline
assessment of lateral flexion range of motion using smartphone
Time frame: at baseline
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Lumbar Pain Syndrome, run by Cairo University at 1 site in Egypt.
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 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 2 Jul 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 Egypt. 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 flexion and extension range of motion using inclinometer (time frame: at baseline). The study lists 2 primary outcomes in all. 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 2 Jul 2026.