Cerebral PalsyNCT07730086
Smartphone Accelerometry for Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
An observational study of Cerebral Palsy and Unilateral Spastic Cerebral Palsy, run by Deraya University at 1 site in Egypt.
Trial summary
This observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Unilateral Spastic Cerebral Palsy
- What is being tested?
- Smartphone-Embedded Gait Assessment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: A convenience sample of children aged 6 to 12 years with a clinical diagnosis of unilateral spastic cerebral palsy will be recruited from the Deraya University outpatient clinic. Eligible participants will be classified as Gross Motor Function Classification System level I or II and must be able to walk independently for 10 meters without physical assistance or handheld mobility aids. Participants must also be able to understand and follow simple verbal instructions required for gait assessment.
Who may be able to join
- Clinical diagnosis of unilateral spastic cerebral palsy.
- Chronological age ranging from 6 to 12 years.
- Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
- Ability to comprehend and execute simple verbal instructions during clinical evaluation.
Who cannot join
- History of lower extremity corrective orthopedic surgery or joint casting within the preceding 12 months.
- Botulinum Toxin Type A injections administered to the lower limbs within the past 6 months.
- Fixed structural bony deformities or rigid joint contractures in the lower extremities.
- Severe, uncorrected visual or auditory deficits that threaten safety or test execution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Deraya university, faculty of pharmacy
Minya, Menia Governorate
Aliaa Gamal Hussien, +20 1003041632, aliaa.gamal@deraya.edu.eg
About this study
Official title: Concurrent Validity and Test-Retest Reliability of Smartphone-Embedded Accelerometry for Spatiotemporal Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
This observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy.
Thirty-five children aged 6 to 12 years will complete two walking trials along a 10-meter indoor walkway at their usual comfortable speed. During each trial, a smartphone will be secured over the lower back at the L4-L5 level to record body acceleration using the Phyphox application. At the same time, a video camera will record the child's walking for analysis using Kinovea software.
Read more
Measurements obtained from the smartphone will be compared with measurements obtained from video analysis. The study will assess walking velocity, cadence, stride timing, and gait asymmetry. The two repeated walking trials will also be used to determine whether the smartphone measurements are consistent when the test is repeated during the same session.
The study does not involve any treatment or change to the child's usual medical or physical therapy care. The purpose is to determine whether smartphone-based gait assessment may be a practical, low-cost method for evaluating walking in children with unilateral spastic cerebral palsy.
Read the detailed description
Children with unilateral spastic cerebral palsy may have differences in walking speed, step timing, cadence, and symmetry between the affected and unaffected lower limbs. Instrumented gait laboratories can provide detailed gait measurements, but they may be expensive, time-consuming, or unavailable in many clinical settings. Smartphones contain built-in motion sensors that may offer a simpler and more accessible method of measuring gait.
This methodological validation study will examine the concurrent validity and intra-session test-retest reliability of smartphone-embedded linear accelerometry for the assessment of spatiotemporal gait parameters in children with unilateral spastic cerebral palsy.
A convenience sample of 35 children will be recruited from the Deraya University outpatient clinic. Eligible participants will be 6 to 12 years of age, have a clinical diagnosis of unilateral spastic cerebral palsy, and be classified as Gross Motor Function Classification System level I or II.
Each participant will attend one assessment session. A Samsung Galaxy A7 smartphone will be secured horizontally over the lower back at the L4-L5 vertebral level using an adjustable waist belt. This location is intended to approximate the body's center of mass. The smartphone's internal linear accelerometer will record movement data using the Phyphox application.
Participants will walk at a comfortable, self-selected speed along a flat, unobstructed 10-meter indoor walkway. At the same time, a high-definition video camera mounted on a stable tripod will record the walking trial from a perpendicular distance of approximately 3 meters. The video recordings will be analyzed frame by frame using Kinovea software and will serve as the reference method.
Each child will complete two identical walking trials during the same session. The trials will be separated by a seated rest period of approximately 5 to 10 minutes to reduce fatigue. No therapeutic intervention will be administered, and the child's usual medical or physical therapy care will not be changed.
Data obtained from the smartphone accelerometer and the video analysis will be used to calculate walking velocity, cadence, stride timing, and gait asymmetry. Smartphone-derived measurements will be compared with the corresponding Kinovea-derived measurements to evaluate concurrent validity. Measurements from the first and second walking trials will also be compared to evaluate intra-session test-retest reliability.
The study is intended to determine whether smartphone-based accelerometry can provide valid and repeatable gait measurements that may be useful as a practical, non-invasive, and low-cost clinical assessment method for children with unilateral spastic cerebral palsy.
- Conditions
- Cerebral Palsy, Unilateral Spastic Cerebral Palsy
- Being tested
- Smartphone-Embedded Gait Assessment
- Keywords
- Smartphone Accelerometry, Gait Analysis, Spatiotemporal Gait Parameters, Unilateral Spastic Cerebral Palsy, Hemiplegic Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Embedded Gait AssessmentDiagnostic test
A Samsung Galaxy A7 smartphone will be secured horizontally over the participant's lower back at the L4-L5 vertebral level using an adjustable waist belt. The smartphone's built-in linear accelerometer and the Phyphox application will record movement during two 10-meter walking trials performed at a comfortable, self-selected speed. Simultaneous video recordings will be analyzed using Kinovea software as the reference method. Walking velocity, cadence, stride timing, and gait asymmetry will be calculated. The two trials will be separated by a seated rest period of 5 to 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Children With Unilateral Spastic Cerebral Palsy | A convenience sample of 35 children aged 6 to 12 years with unilateral spastic cerebral palsy and Gross Motor Function Classification System levels I or II. All participants will complete two 10-meter walking trials while smartphone accelerometry and simultaneous 2-dimensional video gait analysis are performed. No treatment will be assigned or modified. Receives: Diagnostic Test: Smartphone-Embedded Gait Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Velocity Measured by Smartphone Accelerometry
Walking velocity, expressed in meters per second, will be calculated by dividing the 10-meter walking distance by the time required to complete the walkway. Velocity derived from smartphone linear accelerometry using the Phyphox application will be compared with velocity obtained from frame-by-frame 2-dimensional video analysis using Kinovea software.
Measured: Baseline
Cadence Measured by Smartphone Accelerometry
Cadence, expressed as steps per minute, will be calculated from acceleration peak intervals recorded by the smartphone using the Phyphox application. Smartphone-derived cadence will be compared with cadence determined by visual frame-by-frame analysis of the simultaneous Kinovea video recording.
Measured: Baseline
Gait Asymmetry Index
The Gait Asymmetry Index will be calculated using temporal gait data from the affected and unaffected lower limbs. The index will quantify the degree of asymmetry between the two sides. Smartphone-derived asymmetry values will be compared with values obtained from the simultaneous Kinovea video analysis. Higher values indicate greater gait asymmetry.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730086
- Sponsor's protocol ID
- PT-USCP-GAIT-01
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schow, E., Bugge, C., & Jensen, K. (2014). Trunk accelerometry using a smartphone for standard clinical gait evaluation: A reliability study. Journal of NeuroEngineering and Rehabilitation, 11(1), 37.
Plotnik M, Giladi N, Hausdorff JM. A new measure for quantifying the bilateral coordination of human gait: effects of aging and Parkinson's disease. Exp Brain Res. 2007 Aug;181(4):561-70. doi: 10.1007/s00221-007-0955-7. Epub 2007 May 15.
PubMed 17503027Fernández-González, P., Carratalá-Tejada, M., Monge-Pereira, E., & Miangolarra-Page, J. C. (2020). Reliability and validation of 2D video analysis using Kinovea software for assessment of spatiotemporal gait parameters. Medical Engineering & Physics, 78, 45-51.
Almqvist, L., & Riad, J. (2020). Accelerometer-based gait analysis in children with cerebral palsy: Validation and clinical utility of spatiotemporal parameters. Developmental Medicine & Child Neurology, 62(7), 834-840.
Silsupadol P, Teja K, Lugade V. Reliability and validity of a smartphone-based assessment of gait parameters across walking speed and smartphone locations: Body, bag, belt, hand, and pocket. Gait Posture. 2017 Oct;58:516-522. doi: 10.1016/j.gaitpost.2017.09.030. Epub 2017 Sep 23.
PubMed 28961548Balsalobre-Fernandez C, Tejero-Gonzalez CM, del Campo-Vecino J, Bavaresco N. The concurrent validity and reliability of a low-cost, high-speed camera-based method for measuring the flight time of vertical jumps. J Strength Cond Res. 2014 Feb;28(2):528-33. doi: 10.1519/JSC.0b013e318299a52e.
PubMed 23689339Staacks, S., Hütz, S., Heinke, H., & Stampfer, J. (2018). Advanced smartphone-based experiments with phyphox. Physics Education, 53(4), 045009.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Validity and Test-Retest Reliability of Smartphone-Embedded Accelerometry for Spatiotemporal Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07730086
- Acronym / sponsor ID
- PT-USCP-GAIT-01
- Conditions
- Cerebral Palsy, Unilateral Spastic Cerebral Palsy
- Keywords
- Smartphone Accelerometry, Gait Analysis, Spatiotemporal Gait Parameters, Unilateral Spastic Cerebral Palsy, Hemiplegic Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 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 observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy.
Thirty-five children aged 6 to 12 years will complete two walking trials along a 10-meter indoor walkway at their usual comfortable speed. During each trial, a smartphone will be secured over the lower back at the L4-L5 level to record body acceleration using the Phyphox application. At the same time, a video camera will record the child's walking for analysis using Kinovea software.
Measurements obtained from the smartphone will be compared with measurements obtained from video analysis. The study will assess walking velocity, cadence, stride timing, and gait asymmetry. The two repeated walking trials will also be used to determine whether the smartphone measurements are consistent when the test is repeated during the same session.
The study does not involve any treatment or change to the child's usual medical or physical therapy care. The purpose is to determine whether smartphone-based gait assessment may be a practical, low-cost method for evaluating walking in children with unilateral spastic cerebral palsy.
Detailed description
Children with unilateral spastic cerebral palsy may have differences in walking speed, step timing, cadence, and symmetry between the affected and unaffected lower limbs. Instrumented gait laboratories can provide detailed gait measurements, but they may be expensive, time-consuming, or unavailable in many clinical settings. Smartphones contain built-in motion sensors that may offer a simpler and more accessible method of measuring gait.
This methodological validation study will examine the concurrent validity and intra-session test-retest reliability of smartphone-embedded linear accelerometry for the assessment of spatiotemporal gait parameters in children with unilateral spastic cerebral palsy.
A convenience sample of 35 children will be recruited from the Deraya University outpatient clinic. Eligible participants will be 6 to 12 years of age, have a clinical diagnosis of unilateral spastic cerebral palsy, and be classified as Gross Motor Function Classification System level I or II.
Each participant will attend one assessment session. A Samsung Galaxy A7 smartphone will be secured horizontally over the lower back at the L4-L5 vertebral level using an adjustable waist belt. This location is intended to approximate the body's center of mass. The smartphone's internal linear accelerometer will record movement data using the Phyphox application.
Participants will walk at a comfortable, self-selected speed along a flat, unobstructed 10-meter indoor walkway. At the same time, a high-definition video camera mounted on a stable tripod will record the walking trial from a perpendicular distance of approximately 3 meters. The video recordings will be analyzed frame by frame using Kinovea software and will serve as the reference method.
Each child will complete two identical walking trials during the same session. The trials will be separated by a seated rest period of approximately 5 to 10 minutes to reduce fatigue. No therapeutic intervention will be administered, and the child's usual medical or physical therapy care will not be changed.
Data obtained from the smartphone accelerometer and the video analysis will be used to calculate walking velocity, cadence, stride timing, and gait asymmetry. Smartphone-derived measurements will be compared with the corresponding Kinovea-derived measurements to evaluate concurrent validity. Measurements from the first and second walking trials will also be compared to evaluate intra-session test-retest reliability.
The study is intended to determine whether smartphone-based accelerometry can provide valid and repeatable gait measurements that may be useful as a practical, non-invasive, and low-cost clinical assessment method for children with unilateral spastic cerebral palsy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Unilateral Spastic Cerebral Palsy | – | Diagnostic Test: Smartphone-Embedded Gait AssessmentA convenience sample of 35 children aged 6 to 12 years with unilateral spastic cerebral palsy and Gross Motor Function Classification System levels I or II. All participants will complete two 10-meter walking trials while smartphone accelerometry and simultaneous 2-dimensional video gait analysis are performed. No treatment will be assigned or modified. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A convenience sample of children aged 6 to 12 years with a clinical diagnosis of unilateral spastic cerebral palsy will be recruited from the Deraya University outpatient clinic. Eligible participants will be classified as Gross Motor Function Classification System level I or II and must be able to walk independently for 10 meters without physical assistance or handheld mobility aids. Participants must also be able to understand and follow simple verbal instructions required for gait assessment.
Key inclusion criteria (4 listed)
- Clinical diagnosis of unilateral spastic cerebral palsy.
- Chronological age ranging from 6 to 12 years.
- Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
- Ability to comprehend and execute simple verbal instructions during clinical evaluation.
Key exclusion criteria (4 listed)
- History of lower extremity corrective orthopedic surgery or joint casting within the preceding 12 months.
- Botulinum Toxin Type A injections administered to the lower limbs within the past 6 months.
- Fixed structural bony deformities or rigid joint contractures in the lower extremities.
- Severe, uncorrected visual or auditory deficits that threaten safety or test execution
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 |
|---|---|---|
| Smartphone-Embedded Gait AssessmentA Samsung Galaxy A7 smartphone will be secured horizontally over the participant's lower back at the L4-L5 vertebral level using an adjustable waist belt. The smartphone's built-in linear accelerometer and the Phyphox application will record movement during two 10-meter walking trials performed at a comfortable, self-selected speed. Simultaneous video recordings will be analyzed using Kinovea software as the reference method. Walking velocity, cadence, stride timing, and gait asymmetry will be calculated. The two trials will be separated by a seated rest period of 5 to 10 minutes. | Diagnostic test | Children With Unilateral Spastic Cerebral Palsy |
Primary outcome
Walking Velocity Measured by Smartphone Accelerometry
Time frame: Baseline
Walking velocity, expressed in meters per second, will be calculated by dividing the 10-meter walking distance by the time required to complete the walkway. Velocity derived from smartphone linear accelerometry using the Phyphox application will be compared with velocity obtained from frame-by-frame 2-dimensional video analysis using Kinovea software.
Cadence Measured by Smartphone Accelerometry
Time frame: Baseline
Cadence, expressed as steps per minute, will be calculated from acceleration peak intervals recorded by the smartphone using the Phyphox application. Smartphone-derived cadence will be compared with cadence determined by visual frame-by-frame analysis of the simultaneous Kinovea video recording.
Gait Asymmetry Index
Time frame: Baseline
The Gait Asymmetry Index will be calculated using temporal gait data from the affected and unaffected lower limbs. The index will quantify the degree of asymmetry between the two sides. Smartphone-derived asymmetry values will be compared with values obtained from the simultaneous Kinovea video analysis. Higher values indicate greater gait asymmetry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- BackgroundSchow, E., Bugge, C., & Jensen, K. (2014). Trunk accelerometry using a smartphone for standard clinical gait evaluation: A reliability study. Journal of NeuroEngineering and Rehabilitation, 11(1), 37.
- Background: PubMed 17503027Plotnik M, Giladi N, Hausdorff JM. A new measure for quantifying the bilateral coordination of human gait: effects of aging and Parkinson's disease. Exp Brain Res. 2007 Aug;181(4):561-70. doi: 10.1007/s00221-007-0955-7. Epub 2007 May 15.
- BackgroundFernández-González, P., Carratalá-Tejada, M., Monge-Pereira, E., & Miangolarra-Page, J. C. (2020). Reliability and validation of 2D video analysis using Kinovea software for assessment of spatiotemporal gait parameters. Medical Engineering & Physics, 78, 45-51.
- BackgroundAlmqvist, L., & Riad, J. (2020). Accelerometer-based gait analysis in children with cerebral palsy: Validation and clinical utility of spatiotemporal parameters. Developmental Medicine & Child Neurology, 62(7), 834-840.
- Background: PubMed 28961548Silsupadol P, Teja K, Lugade V. Reliability and validity of a smartphone-based assessment of gait parameters across walking speed and smartphone locations: Body, bag, belt, hand, and pocket. Gait Posture. 2017 Oct;58:516-522. doi: 10.1016/j.gaitpost.2017.09.030. Epub 2017 Sep 23.
- Background: PubMed 23689339Balsalobre-Fernandez C, Tejero-Gonzalez CM, del Campo-Vecino J, Bavaresco N. The concurrent validity and reliability of a low-cost, high-speed camera-based method for measuring the flight time of vertical jumps. J Strength Cond Res. 2014 Feb;28(2):528-33. doi: 10.1519/JSC.0b013e318299a52e.
- BackgroundStaacks, S., Hütz, S., Heinke, H., & Stampfer, J. (2018). Advanced smartphone-based experiments with phyphox. Physics Education, 53(4), 045009.
- 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.
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 Cerebral Palsy and Unilateral Spastic Cerebral Palsy, run by Deraya 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 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: looking for participants now, as of the sponsor's last update on 28 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shereen Ali Amin (01112929145 ext. +20, Shereen.ali@deraya.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Velocity Measured by Smartphone Accelerometry (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07730086, which also lists 7 linked publications.
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 28 Jul 2026.