Core Strength for Head Control and Quality of Life in Cerebral Palsy

NCT07613515 | Completed

• 1 other identifier: HA-02-J-008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic

Outcome Measures

Primary Outcomes (3)

• Head Control Scale (HCS)

  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.

  Baseline, 4-week and 8-week

• Segmental Assessment of Trunk Control (SATCo)

  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).

  Baseline, 4-week and 8-week

• Functional Strength Assessment (FSA)

  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.

  Baseline, 4-week and 8-week

Secondary Outcomes (2)

• Gross Motor Function Measure-66

  Baseline, 4-week and 8-week

• Caregiver Priorities and Child Health Index of Life with Disabilities

  Baseline, 4-week and 8-week

Study Arms (1)

Core Strength Training

EXPERIMENTAL

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.

Behavioral: Core Strength Training

Interventions

Core Strength Training BEHAVIORAL

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.

Core Strength Training

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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').

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• King Abdulaziz University: collaborator

Study Sites (1)

Faculty of Medical Rehabilitation Sciences

Jeddah, Saudi Arabia

Location

Related Publications (1)

• Saavedra SL, Woollacott MH. Segmental Contributions to Trunk Control in Children With Moderate-to-Severe Cerebral Palsy. Arch Phys Med Rehabil. 2015 Jun;96(6):1088-97. doi: 10.1016/j.apmr.2015.01.016. Epub 2015 Feb 2.

  PMID: 25656342 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)