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Smartphone Accelerometry for Gait Analysis in Children With Unilateral Spastic Cerebral Palsy

24 de julio de 2026 actualizado por: Deraya University

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

35

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Menia Governorate
      • Minya, Menia Governorate, Egipto
        • Reclutamiento
        • Deraya university, faculty of pharmacy
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion criteria:

  1. Clinical diagnosis of unilateral spastic cerebral palsy.
  2. Chronological age ranging from 6 to 12 years.
  3. Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
  4. Ability to comprehend and execute simple verbal instructions during clinical evaluation.

Exclusion criteria:

  1. History of lower extremity corrective orthopedic surgery or joint casting within the preceding 12 months.
  2. Botulinum Toxin Type A injections administered to the lower limbs within the past 6 months.
  3. Fixed structural bony deformities or rigid joint contractures in the lower extremities.
  4. Severe, uncorrected visual or auditory deficits that threaten safety or test execution

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Walking Velocity Measured by Smartphone Accelerometry
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

16 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2026

Publicado por primera vez (Actual)

28 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PT-USCP-GAIT-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .