CompletedNot Applicable

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

Saudi Arabia38 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Head Control Scale (HCS)

Timeframe: Baseline, 4-week and 8-week

Segmental Assessment of Trunk Control (SATCo)

Timeframe: Baseline, 4-week and 8-week

Functional Strength Assessment (FSA)

Timeframe: Baseline, 4-week and 8-week

Trial details

NCT IDNCT07613515

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.