Core Strength for Head Control and Quality of Life in Cerebral Palsy
24 de mayo de 2026 actualizado por: Tamer Mohamed El-Saeed, Cairo University
Effect of Core Strength Training on Head and Trunk Control and Quality of Life in Spastic Cerebral Palsy
The goal of this observational study is to examine the effect of an 8-week therapist-assisted core muscle strengthening program on head control, trunk stability, functional core strength, quality of life, and automatic righting reactions in non-ambulatory children with spastic cerebral palsy. The main questions it aims to answer are:
- Does head control improve over time in supine, prone, and supported sitting?
- Does segmental trunk control improve across static, active, and reactive tasks?
- Does functional cervico-trunk strength improve?
- Do automatic righting reactions change after the intervention?
Participants will:
- Take part in 24 therapy sessions over 8 weeks.
- Receive therapist-assisted core activation exercises such as bridging, modified quadruped over a bolster, supported sitting on a therapy ball with multidirectional perturbations, and assisted pull-to-sit.
- Complete assessments at baseline, week 4, and week 8 for head control, trunk control, functional strength, and righting reactions.
Researchers will compare participants' outcomes across baseline, mid-intervention, and post-intervention time points to see whether the program is associated with improvements in motor control and function.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
Fase
- No aplica
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.
Ubicaciones de estudio
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Jeddah, Arabia Saudita
- Faculty of Medical Rehabilitation Sciences
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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
Descripción
Inclusion criteria
- Confirmed medical diagnosis of spastic cerebral palsy.
- Chronological age 4-10 years.
- GMFCS Level IV or V.
- Demonstrated impairment of head control, operationalized as a Head Control Scale score of 1 or 2 in prone, supine, or supported sitting at screening, ensuring measurable baseline deficit with biological capacity for improvement.
- Sufficient receptive cognitive and language capacity to attempt simple, modified therapeutic instructions (e.g., 'look up,' 'hold').
Exclusion criteria
- Fixed structural spinal deformity, defined as Cobb angle > 30° on most recent radiographic assessment.
- Orthopedic surgery within the preceding 12 months.
- Botulinum toxin type-A (BoNT-A) injection to trunk or cervical musculature within the preceding 6 months.
- Uncontrolled seizure disorder posing safety risk during physical exertion.
- Uncorrected severe visual or auditory impairment precluding response to therapeutic stimuli.
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
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Core Strength Training
The group received Physical therapy program in addition to core strength training to investigate the head and trunk control as well as quality of life.
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The intervention comprised 24 sessions (3 × 45-50 min weekly) of warm-up, therapist-assisted core activation (bridging, modified quadruped over bolster, supported sitting on therapy ball with multidirectional perturbations, assisted pull-to-sit), and cool-down.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Head Control Scale (HCS)
Periodo de tiempo: Baseline, 4-week and 8-week
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The HCS served as the primary outcome measure.
It is a 5-point ordinal scale (0 = no control, 4 = complete head control) developed and validated by Thomas et al. (2019) for children with significant motor delay.
The scale grades the child's capacity to initiate, maintain, and orient the head against gravity in three standardized positions: supine, prone, and supported sitting.
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Baseline, 4-week and 8-week
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Segmental Assessment of Trunk Control (SATCo)
Periodo de tiempo: Baseline, 4-week and 8-week
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The SATCo was used as the primary measure of hierarchical trunk control.
The instrument evaluates trunk control across seven sequential anatomical segments: head, upper thoracic, mid-thoracic, lower thoracic, upper lumbar, lower lumbar, and full trunk.
At each segment, the examiner provides manual stabilization immediately below the segment under test and grades three control domains: static (maintaining posture without external perturbation), active (maintaining posture during voluntary head or upper-limb movement), and reactive (maintaining posture during external perturbation).
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Baseline, 4-week and 8-week
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Functional Strength Assessment (FSA)
Periodo de tiempo: Baseline, 4-week and 8-week
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The FSA, used here as a clinically pragmatic alternative, grades functional muscle recruitment during structured transitional maneuvers on a 1-5 ordinal scale.
Cervical and trunk flexor strength was assessed via the pull-to-sit maneuver, examining the child's ability to actively flex the head and trunk against the examiner's slow upward traction.
Cervical and trunk extensor strength was assessed via prone suspension over the therapist's lap, examining the child's ability to extend the head and upper trunk against gravity from a supported prone position.
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Baseline, 4-week and 8-week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gross Motor Function Measure-66
Periodo de tiempo: Baseline, 4-week and 8-week
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The Gross Motor Function Measure-66 (GMFM-66) is a criterion-referenced, Rasch-modelled instrument designed to evaluate change in gross motor function in children with cerebral palsy.
For children at GMFCS levels IV and V, the Item Set-1 short form, derived from the full 66-item scale to reduce respondent burden while preserving measurement properties for severe phenotypes, was used in this trial.
Scores are expressed on a 0-100 interval scale, with higher values indicating greater motor capacity.
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Baseline, 4-week and 8-week
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Caregiver Priorities and Child Health Index of Life with Disabilities
Periodo de tiempo: Baseline, 4-week and 8-week
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The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) is a parent-completed, condition-specific, multidimensional measure of health-related quality of life developed and validated specifically for children with severe non-ambulant cerebral palsy.
The instrument covers six domains-activities of daily living/personal care, positioning/transferring/mobility, comfort and emotions, communication and social interaction, health, and overall quality of life-and yields a transformed total score ranging from 0 to 100, with higher scores reflecting better caregiver-reported function and quality of life.
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Baseline, 4-week and 8-week
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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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 mayo de 2025
Finalización primaria (Actual)
31 de diciembre de 2025
Finalización del estudio (Actual)
1 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Hipertonía muscular
- Manifestaciones Neuromusculares
- Daño Cerebral Crónico
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Espasticidad muscular
- Parálisis cerebral
Otros números de identificación del estudio
- HA-02-J-008
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
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