- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07613515
Core Strength for Head Control and Quality of Life in Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jeddah, Saudi Arabia
- Faculty of Medical Rehabilitation Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head Control Scale (HCS)
Time Frame: 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.
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Baseline, 4-week and 8-week
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Segmental Assessment of Trunk Control (SATCo)
Time Frame: 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)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gross Motor Function Measure-66
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Brain Damage, Chronic
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Spasticity
- Cerebral Palsy
Other Study ID Numbers
- HA-02-J-008
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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