Cerebral PalsyNCT07613515
Core Strength for Head Control and Quality of Life in Cerebral Palsy
A study testing Core Strength Training in people with Cerebral Palsy and Spastic, run by Cairo University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Core Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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').
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Being tested
- Core Strength Training
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Strength TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Core Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline, 4-week and 8-week
Secondary outcomes (2)
Gross Motor Function Measure-66
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.
Measured: Baseline, 4-week and 8-week
Caregiver Priorities and Child Health Index of Life with Disabilities
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.
Measured: Baseline, 4-week and 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 May 2025
- Primary completion31 Dec 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Principal investigator, Tamer Mohamed El-Saeed, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613515
- Sponsor's protocol ID
- HA-02-J-008
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25656342
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Strength Training on Head and Trunk Control and Quality of Life in Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07613515
- Acronym / sponsor ID
- HA-02-J-008
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Core Strength Training | Experimental | Behavioral: Core Strength TrainingThe group received Physical therapy program in addition to core strength training to investigate the head and trunk control as well as quality of life. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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').
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Strength TrainingThe 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. | Behavioural | Core Strength Training |
Primary outcome
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.
Segmental Assessment of Trunk Control (SATCo)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Gross Motor Function Measure-66
Time frame: Baseline, 4-week and 8-week
Caregiver Priorities and Child Health Index of Life with Disabilities
Time frame: Baseline, 4-week and 8-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 25656342Saavedra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Strength Training in people with Cerebral Palsy and Spastic, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head Control Scale (HCS) (time frame: Baseline, 4-week and 8-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07613515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.