Cerebral Palsy (CP)CORE-CPNCT06973213
Core Stabilization for Upper Extremity Function and Balance in Children With Cerebral Palsy
A study testing core exercises in people with Cerebral Palsy (CP) and Upper Extremity Function, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of core stabilization exercises on balance and upper extremity function in children with cerebral palsy (CP). A total of 36 children aged 5 to 12 years with CP were randomly assigned to either an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Upper Extremity Function, Core Stabilization Exercise Therapy
- What is being tested?
- core exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 27 Dec 2024
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Who had no other medical conditions that could affect the evaluation and had not had surgery in the past six months.
Exclusion Criteria: Children with severe intellectual disability, muscle contractures or bone deformities, visual impairments, uncontrolled seizures, other neuromuscular diseases, spinocerebellar ataxia, autism spectrum disorder, or communication disorders, as well as children diagnosed with hyperactivity and attention deficit disorder, were excluded from the evaluation. Patients classified as level IV or V according to the Gross Motor Function Classification System (GMFCS), with a spasticity level of 3 or higher according to the Modified Ashworth Scale (MAS), and classified as level IV or V according to the Manual Ability Classification System (MACS) were not included in the study. -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University,Vocational School of Kocaeli Health Services, Kocaeli University, Umuttepe Campus, 41380, Kocaeli, TURKEY.
Kocaeli, Izmit, 41380
About this study
Official title: The Effect of Core Stabilization Exercises on Upper Extremity Function and Balance in Children With Cerebral Palsy: A Randomized Controlled Trial
This study investigates the effects of core stabilization exercises on balance and upper extremity function in children with cerebral palsy (CP). A total of 36 children aged 5 to 12 years with CP were randomly assigned to either an intervention group or a control group. Both groups received standard physiotherapy, rehabilitation, and occupational therapy five days a week for four weeks. In addition, the intervention group performed daily core stabilization exercises for approximately 45 minutes. The study assessed balance using the Pediatric Berg Balance Scale and the Trunk Control Measurement Scale, and upper extremity function using the Box and Block Test and the Assisting Hand Assessment before and after the treatment period.
Read the detailed description
Cerebral palsy (CP) is a group of permanent disorders of movement and posture that occur due to non-progressive disturbances in the developing fetal or infant brain. Children with CP often experience deficits in trunk control, balance, and upper extremity function, which significantly affect their daily activities and quality of life. Core stabilization exercises are widely used in neurorehabilitation to improve trunk control and postural stability, potentially enhancing balance and upper limb function.
This randomized controlled trial aimed to evaluate the effects of core stabilization exercises on upper extremity function and balance in children with CP. The study included children aged 5 to 12 years, classified at levels I-III according to the Gross Motor Function Classification System (GMFCS) and the Manual Ability Classification System (MACS), and with spasticity levels ≤2 according to the Modified Ashworth Scale (MAS). Participants were randomly assigned to either an intervention or a control group. Both groups received a standardized physiotherapy and occupational therapy program five days a week for four weeks. In addition to the standard care, the intervention group performed daily 45-minute sessions of core stabilization exercises.
Outcome measures included the Pediatric Berg Balance Scale (PBBS) and the Trunk Control Measurement Scale (TCMS) for evaluating balance, and the Box and Block Test (BBT) and the Assisting Hand Assessment (AHA) for assessing upper extremity function. Assessments were conducted at baseline and post-intervention. The study hypothesized that children receiving core stabilization exercises in addition to standard therapy would show greater improvements in balance and upper extremity function compared to those receiving standard therapy alone.
- Conditions
- Cerebral Palsy (CP), Upper Extremity Function, Core Stabilization Exercise Therapy, Balance, Trunk Stability
- Being tested
- core exercises
- Keywords
- cerebral palsy, upper extremity function, core stabilization exercises, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core exercisesOther
the intervention group underwent approximately 45 minutes of core stabilization exercises daily.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Active comparator | Not described Receives: Other: core exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Mar 2024
- Primary completion20 Dec 2024
- Study completion27 Dec 2024
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 Palsy (CP)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Çekmece, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973213
- Sponsor's protocol ID
- KAEK/01.b1.02
- Other IDs
- E-66175679-514.13.02-1407423
- Acronym
- CORE-CP
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucuk KE, Cekmece C. The Effect of Core Stabilization Exercises on Upper Extremity Function and Balance in Children with Cerebral Palsy: A Randomized Controlled Trial. Healthcare (Basel). 2025 Jun 17;13(12):1454. doi: 10.3390/healthcare13121454.
PubMed 40565481
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Exercises on Upper Extremity Function and Balance in Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06973213
- Acronym / sponsor ID
- CORE-CP / KAEK/01.b1.02
- Conditions
- Cerebral Palsy (CP), Upper Extremity Function, Core Stabilization Exercise Therapy, Balance, Trunk Stability
- Keywords
- cerebral palsy, upper extremity function, core stabilization exercises, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 15 May 2025 (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.
This study investigates the effects of core stabilization exercises on balance and upper extremity function in children with cerebral palsy (CP). A total of 36 children aged 5 to 12 years with CP were randomly assigned to either an intervention group or a control group. Both groups received standard physiotherapy, rehabilitation, and occupational therapy five days a week for four weeks. In addition, the intervention group performed daily core stabilization exercises for approximately 45 minutes. The study assessed balance using the Pediatric Berg Balance Scale and the Trunk Control Measurement Scale, and upper extremity function using the Box and Block Test and the Assisting Hand Assessment before and after the treatment period.
Detailed description
Cerebral palsy (CP) is a group of permanent disorders of movement and posture that occur due to non-progressive disturbances in the developing fetal or infant brain. Children with CP often experience deficits in trunk control, balance, and upper extremity function, which significantly affect their daily activities and quality of life. Core stabilization exercises are widely used in neurorehabilitation to improve trunk control and postural stability, potentially enhancing balance and upper limb function.
This randomized controlled trial aimed to evaluate the effects of core stabilization exercises on upper extremity function and balance in children with CP. The study included children aged 5 to 12 years, classified at levels I-III according to the Gross Motor Function Classification System (GMFCS) and the Manual Ability Classification System (MACS), and with spasticity levels ≤2 according to the Modified Ashworth Scale (MAS). Participants were randomly assigned to either an intervention or a control group. Both groups received a standardized physiotherapy and occupational therapy program five days a week for four weeks. In addition to the standard care, the intervention group performed daily 45-minute sessions of core stabilization exercises.
Outcome measures included the Pediatric Berg Balance Scale (PBBS) and the Trunk Control Measurement Scale (TCMS) for evaluating balance, and the Box and Block Test (BBT) and the Assisting Hand Assessment (AHA) for assessing upper extremity function. Assessments were conducted at baseline and post-intervention. The study hypothesized that children receiving core stabilization exercises in addition to standard therapy would show greater improvements in balance and upper extremity function compared to those receiving standard therapy alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Active comparator | Other: core exercises |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 exercisesthe intervention group underwent approximately 45 minutes of core stabilization exercises daily. | Other | intervention |
Primary outcome
Assisting Hand Assessment (AHA)
Time frame: From enrollment to the end of treatment at 4 weeks
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 15 May 2025.
- Derived from this study: PubMed 40565481Kucuk KE, Cekmece C. The Effect of Core Stabilization Exercises on Upper Extremity Function and Balance in Children with Cerebral Palsy: A Randomized Controlled Trial. Healthcare (Basel). 2025 Jun 17;13(12):1454. doi: 10.3390/healthcare13121454.
- 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 exercises in people with Cerebral Palsy (CP) and Upper Extremity Function, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2025. 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 Turkey (Türkiye). 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?
Assisting Hand Assessment (AHA) (time frame: From enrollment to the end of treatment at 4 weeks). 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 NCT06973213, 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 15 May 2025.