- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07680231
Smartphone Versus Back Range of Motion: Validity and Reliability in Lumbar Range of Motion Assessment
June 29, 2026 updated by: Loay Akmal Ali, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12613
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy University Students with normal BMI Healthy Male university students
Description
Inclusion Criteria:
- Age 18-25 years old
- Healthy Male university students
- All participants have normal BMI
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at baseline
|
|
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]
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of flexion and extension range of motion using smartphone
Time Frame: at baseline
|
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.
|
at baseline
|
|
assessment of lateral flexion range of motion using smartphone
Time Frame: at baseline
|
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
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
May 12, 2026
Study Registration Dates
First Submitted
June 14, 2026
First Submitted That Met QC Criteria
June 29, 2026
First Posted (Actual)
July 2, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Pain Syndrome
-
ElsanNot yet recruiting
-
Keith M VogtRecruitingLow Back Pain | Chronic Low-back Pain | Back Pain Lower Back Chronic | Lumbar Disc Disease | Lumbar Pain Syndrome | Pain;Back Low;Chronic | Back Pain, Low | Back Pain Without Radiation | Lumbar Post-Laminectomy Syndrome | Lumbar Discogenic PainUnited States
-
MedianJohannes Gutenberg University MainzCompletedLumbar Pain SyndromeGermany
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
-
Ignacio Alejandro Astudillo GanoraCompletedBack Pain | Lumbar Pain Syndrome | Back Pain, LowSpain
-
Mansoura UniversityTanta UniversityCompletedFacet Syndrome of Lumbar SpineEgypt
-
BioWave CorporationYale University; University of Wisconsin, Madison; Center For Interventional...CompletedLow Back Pain | Chronic Pain | Lumbar Pain SyndromeUnited States
-
Anesthesia Research Group UARecruitingLumbar Disc Herniation | Lumbar Spinal Stenosis | Failed Back Surgery Syndrome | Lumbar Discogenic PainUkraine
-
Oznur UzunCompletedLow Back Pain, Mechanical | Facet Syndrome of Lumbar SpineTurkey
-
FUSMobile Inc.CompletedFacet Syndrome of Lumbar SpineUnited States
Clinical Trials on easement tool 1 - BROM device
-
James EtheridgeSingapore General HospitalCompleted
-
Yuzuncu Yil UniversityRecruitingStomach Cancer | Fatigue | Chemotherapy-induced Nausea and VomitingTurkey (Türkiye)
-
Rebiscan, Inc.Carilion ClinicActive, not recruitingBrain Injuries, TraumaticUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Two Pi Signalprocessing Applications GmbHCompletedMild to Moderate Sensorineural Hearing LossNetherlands
-
University of MalayaCompletedPostoperative Delirium | Diagnosis, Psychiatric
-
Sheffield Children's NHS Foundation TrustSheffield Hallam UniversityActive, not recruiting
-
Sheffield Children's NHS Foundation TrustCompletedRheumatologic DiseaseUnited Kingdom
-
Stanford UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBurnout, Professional | Resilience, PsychologicalUnited States
-
University of WashingtonCompletedPhysician Work Environment | Physician Burnout | Artificial Intelligence (AI)United States