Deraya university, faculty of pharmacy
Minya, Menia Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07730086
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.
Interested in participating?
Request Info6 year–12 year
All sexes
Observational
Minya, Menia Governorate, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Deraya University
Other
Concurrent Validity and Test-Retest Reliability of Smartphone-Embedded Accelerometry for Spatiotemporal Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
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