Cerebral Palsy, Spastic
Conditions
Brief summary
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.
Interventions
BEHAVIORALCore Strength Training
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.
Sponsors
Cairo University
King Abdulaziz University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Head Control Scale (HCS) | Baseline, 4-week and 8-week | 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. |
| Segmental Assessment of Trunk Control (SATCo) | Baseline, 4-week and 8-week | 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). |
| Functional Strength Assessment (FSA) | Baseline, 4-week and 8-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure-66 | Baseline, 4-week and 8-week | 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. |
| Caregiver Priorities and Child Health Index of Life with Disabilities | Baseline, 4-week and 8-week | 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. |
Countries
Saudi Arabia
Outcome results
None listed