- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07730086
Smartphone Accelerometry for Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shereen Ali Amin
- Phone Number: +20 01112929145
- Email: Shereen.ali@deraya.edu.eg
Study Locations
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Menia Governorate
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Minya, Menia Governorate, Egypt
- Recruiting
- Deraya university, faculty of pharmacy
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Contact:
- Aliaa Gamal Hussien
- Phone Number: +20 1003041632
- Email: aliaa.gamal@deraya.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Balsalobre-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.
- 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.
- Fernández-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.
- Staacks, S., Hütz, S., Heinke, H., & Stampfer, J. (2018). Advanced smartphone-based experiments with phyphox. Physics Education, 53(4), 045009.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-USCP-GAIT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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