Cerebral PalsyNCT06378723
The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Diplegic Cerebral Palsy, run by Eastern Mediterranean University at 2 sites in 2 countries.
Trial summary
The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Diplegic Cerebral Palsy, Balance; Distorted
- What is being tested?
- Balance Tests
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2024to 16 Apr 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cerebral Palsy and healthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with GMFC levels 1 and 2 will be included in the study.
Who may be able to join
- Between the ages of 8-18,
- Gross Motor Function Classification System level 1-2,
- Do not have severe visual or hearing impairment,
- Does not have any cooperation problems that would hinder communication,
- Children who have had Botulinum Toxin-A injection
Who cannot join
- Those with GMFC level 3-4-5,
- Children who had surgery within the last six months were not included in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Turkey (Türkiye)1 site
Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi
Adana, Çukurova, 01170
About this study
Official title: Investigation of the Relationship Between Functionality, Trunk Control and Balance in Children With Cerebral Palsy
The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit.
Read the detailed description
23 children with Cerebral Palsy and 30 healthy children will be included in the study, and the families of all children participating in the study will sign an informed consent form.After signing the consent form from the families of the children included in the study, their demographic information will be recorded and their Gross Motor Function Classification System levels will be determined.
Children's upper extremity functionality will be evaluated with the Quality of Upper Extremity Skills Test. To determine their functional balance, the Single-Leg Stance Test and the Four Step Square Test are measured. Additionally, balances will be determined by the Trunk Control Measurement Scale. Evaluations are made using tables and chairs. Evaluations take approximately 60 minutes, depending on the condition of the children, and all evaluations will be made one-on-one by the physiotherapist. In the study where power analysis was performed, 50 child evaluations were deemed appropriate. Statistical Package for the Social Sciences package program is used to analyze the data. Whether the data complies with normal distribution will be evaluated using the Shapiro Wilk Test and histogram graphs. Descriptive statistics are given as mean, standard deviation, median, number and percentage. Numerical data between groups are compared using Student's t test and Mann Whitney U test. Categorical data will be compared using the Chi Square test. Spearman's correlation test was used for correlation analysis, p value <0.05 will be considered statistically significant.
- Conditions
- Cerebral Palsy, Diplegic Cerebral Palsy, Balance; Distorted
- Being tested
- Balance Tests
- Keywords
- cerebral palsy, upper extremity, trunk control, functionality, 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.
Balance TestsOther
With the scales and tests the children trunk control, quality of upper extremity skills, single leg stance duration will be measured
| Study group | Role | What they receive |
|---|---|---|
| Healthy Children | Healthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. Receives: Other: Balance Tests | |
| Cerebral Palsy Children | Cerebral Palsy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with Gross Motor Function Classification levels 1 and 2 will be included in the study. Receives: Other: Balance Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
trunk control
All the children will be measured with the Trunk Control Measurement Scale. This test includes 15 items that measure static and dynamic sitting balance, two components of trunk control during functional activities. All items are scored on 2, 3 or 4 points and are administered bilaterally. The total score is between 0-58. A high score indicates good performance.
Measured: one month
upper extremity functionality
All the children will be measured with the Quality of upper extremity skills test. This test evaluates the quality of upper extremity movements; It evaluates in 4 different areas: independent movements, grasping, weight bearing and protective extension. In protective extension, falling to the front, back and side using the arms is evaluated. A "yes" or "no" score is given depending on the completion of each action or task. Scores in these four areas are added together for a total score. Additionally, hand function, spasticity and cooperation are also evaluated. In hand function evaluation, 0 to 10 points are marked for the right hand, left hand and bilaterally. In cooperation, children's cooperation statuses are marked as "not cooperative", "partially cooperative" and "fully cooperative". During the evaluation, the child is not allowed to use any devices for the upper extremity. Both the child's right and left upper extremities are scored separately. Total score is between 0 and 100.
Measured: one month
balance
all the children will be measured with the Four Step Square Test and Single leg Stance test. It is desirable to maintain this posture for as long as possible during the test. The test and duration begin with the foot being lifted off the ground. The test is repeated twice and the best time measured is noted in seconds (for single leg stance). The test begins with one foot of the individual touching the ground in the 2nd square and ends with the last foot touching the ground in the 1st square. The test is repeated twice for each individual and the test score completed in the shortest time is recorded in seconds (four step square test).
Measured: one month
Weight and Height
Weight and height will be combined to report BMI in kg/m2
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Feb 2024
- Primary completion15 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Uğur Tosun, Eastern Mediterranean University
- Investigators
- Emine Tuzun, Prof, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378723
- Sponsor's protocol ID
- 2024/01/24
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Functionality, Trunk Control and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06378723
- Acronym / sponsor ID
- 2024/01/24
- Conditions
- Cerebral Palsy, Diplegic Cerebral Palsy, Balance; Distorted
- Keywords
- cerebral palsy, upper extremity, trunk control, functionality, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 22 Apr 2024 (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 aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit.
Detailed description
23 children with Cerebral Palsy and 30 healthy children will be included in the study, and the families of all children participating in the study will sign an informed consent form.After signing the consent form from the families of the children included in the study, their demographic information will be recorded and their Gross Motor Function Classification System levels will be determined.
Children's upper extremity functionality will be evaluated with the Quality of Upper Extremity Skills Test. To determine their functional balance, the Single-Leg Stance Test and the Four Step Square Test are measured. Additionally, balances will be determined by the Trunk Control Measurement Scale. Evaluations are made using tables and chairs. Evaluations take approximately 60 minutes, depending on the condition of the children, and all evaluations will be made one-on-one by the physiotherapist. In the study where power analysis was performed, 50 child evaluations were deemed appropriate. Statistical Package for the Social Sciences package program is used to analyze the data. Whether the data complies with normal distribution will be evaluated using the Shapiro Wilk Test and histogram graphs. Descriptive statistics are given as mean, standard deviation, median, number and percentage. Numerical data between groups are compared using Student's t test and Mann Whitney U test. Categorical data will be compared using the Chi Square test. Spearman's correlation test was used for correlation analysis, p value <0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Children | – | Other: Balance TestsHealthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. |
| Cerebral Palsy Children | – | Other: Balance TestsCerebral Palsy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with Gross Motor Function Classification levels 1 and 2 will be included in the study. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cerebral Palsy and healthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with GMFC levels 1 and 2 will be included in the study.
Key inclusion criteria (5 listed)
- Between the ages of 8-18,
- Gross Motor Function Classification System level 1-2,
- Do not have severe visual or hearing impairment,
- Does not have any cooperation problems that would hinder communication,
- Children who have had Botulinum Toxin-A injection
Key exclusion criteria (2 listed)
- Those with GMFC level 3-4-5,
- Children who had surgery within the last six months were not included in the study.
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 |
|---|---|---|
| Balance TestsWith the scales and tests the children trunk control, quality of upper extremity skills, single leg stance duration will be measured | Other | Cerebral Palsy Children, Healthy Children |
Primary outcome
trunk control
Time frame: one month
All the children will be measured with the Trunk Control Measurement Scale. This test includes 15 items that measure static and dynamic sitting balance, two components of trunk control during functional activities. All items are scored on 2, 3 or 4 points and are administered bilaterally. The total score is between 0-58. A high score indicates good performance.
upper extremity functionality
Time frame: one month
All the children will be measured with the Quality of upper extremity skills test. This test evaluates the quality of upper extremity movements; It evaluates in 4 different areas: independent movements, grasping, weight bearing and protective extension. In protective extension, falling to the front, back and side using the arms is evaluated. A "yes" or "no" score is given depending on the completion of each action or task. Scores in these four areas are added together for a total score. Additionally, hand function, spasticity and cooperation are also evaluated. In hand function evaluation, 0 to 10 points are marked for the right hand, left hand and bilaterally. In cooperation, children's cooperation statuses are marked as "not cooperative", "partially cooperative" and "fully cooperative". During the evaluation, the child is not allowed to use any devices for the upper extremity. Both the child's right and left upper extremities are scored separately. Total score is between 0 and 100.
balance
Time frame: one month
all the children will be measured with the Four Step Square Test and Single leg Stance test. It is desirable to maintain this posture for as long as possible during the test. The test and duration begin with the foot being lifted off the ground. The test is repeated twice and the best time measured is noted in seconds (for single leg stance). The test begins with one foot of the individual touching the ground in the 2nd square and ends with the last foot touching the ground in the 1st square. The test is repeated twice for each individual and the test score completed in the shortest time is recorded in seconds (four step square test).
Weight and Height
Time frame: one month
Weight and height will be combined to report BMI in kg/m2
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 3 Feb 2026.
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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.
Emine Tuzun, Prof study director
Eastern Mediterranean University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Diplegic Cerebral Palsy, run by Eastern Mediterranean University at 2 sites in 2 countries.
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 2 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus, 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?
trunk control (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.