Cerebral PalsyNCT06439446
Functionality and Family Characteristics in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Family Characteristics, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy, Family Characteristics
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 25 May 2024
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: This study was carried out at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Patients who applied to the Physical Medicine and Rehabilitation Polyclinic with the diagnosis of CP were examined by a physical therapist. Parents of children who met the inclusion criteria were interviewed and informed about the study.
Who may be able to join
- Diagnosed with hemiparetic and diparetic type CP
- Between the ages of 5-15
- GMFCS level I, II and III
- Volunteer individuals were included.
Who cannot join
- Having undergone a surgical operation within the last year,
- Having contracture in the lower extremity,
- Having had a fracture in the lower extremity in the last 6 months,
- Botulinum Toxin A (BTX-A) administered in the last 6 months
- Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
Kırşehir
About this study
Official title: The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability
The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk.
- Conditions
- Cerebral Palsy, Family Characteristics
- Keywords
- Functional Level
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Level
Gross motor function level was measured with Gross Motor Function Measure-66 (GMFM-66). GMFM-66 is a 66-item test developed to measure gross motor skills in children with cerebral palsy and can be evaluated in 5 different categories, including reaching and rolling, sitting, crawling and crawling, standing, walking, running and jumping. It is a 4-point Likert type scale. Higher scores on the test indicate higher gross motor skills.
Measured: 36 week
Parents' Quality of Life
Parents' self-reported quality of life functions such as physical, emotional, social, and cognitive were assessed with The PedsQL Family Impact Module. Total score range is 0-100. Higher scores on the scale indicate less anxiety.
Measured: 36 week
Secondary outcomes (2)
Gross Motor Function Classification
Gross motor functional classification was evaluated with the Gross Motor Function Classification System (GMFCS). GMFCS classifies children with Cerebral Palsy into 5 levels (1-5) based on their motor skills, functional abilities, assistive technologies, and wheelchair needs.
Measured: 36 week
Sociodemographic Form
Characteristic information about the family, such as the family's average monthly income, the number of people living in the family, and the region in which the family lived, was collected.
Measured: 36 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start6 Jun 2023
- Primary completion5 May 2024
- Study completion25 May 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 PalsyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan TURHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439446
- Sponsor's protocol ID
- KAEU-T.ATAHAN-004
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turhan A, Kurt-Aydin M, Tarsuslu T. Determinants of Gross Motor Function in Children With Ambulatory Spastic Cerebral Palsy: A Cross-Sectional Study in Turkey. J Paediatr Child Health. 2025 May;61(5):795-801. doi: 10.1111/jpc.70034. Epub 2025 Mar 18.
PubMed 40099358
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability
- ClinicalTrials.gov ID
- NCT06439446
- Acronym / sponsor ID
- KAEU-T.ATAHAN-004
- Conditions
- Cerebral Palsy, Family Characteristics
- Keywords
- Functional Level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 3 Jun 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 was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study was carried out at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Patients who applied to the Physical Medicine and Rehabilitation Polyclinic with the diagnosis of CP were examined by a physical therapist. Parents of children who met the inclusion criteria were interviewed and informed about the study.
Key inclusion criteria (4 listed)
- Diagnosed with hemiparetic and diparetic type CP
- Between the ages of 5-15
- GMFCS level I, II and III
- Volunteer individuals were included.
Key exclusion criteria (5 listed)
- Having undergone a surgical operation within the last year,
- Having contracture in the lower extremity,
- Having had a fracture in the lower extremity in the last 6 months,
- Botulinum Toxin A (BTX-A) administered in the last 6 months
- Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from 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.
Primary outcome
Gross Motor Function Level
Time frame: 36 week
Gross motor function level was measured with Gross Motor Function Measure-66 (GMFM-66). GMFM-66 is a 66-item test developed to measure gross motor skills in children with cerebral palsy and can be evaluated in 5 different categories, including reaching and rolling, sitting, crawling and crawling, standing, walking, running and jumping. It is a 4-point Likert type scale. Higher scores on the test indicate higher gross motor skills.
Parents' Quality of Life
Time frame: 36 week
Parents' self-reported quality of life functions such as physical, emotional, social, and cognitive were assessed with The PedsQL Family Impact Module. Total score range is 0-100. Higher scores on the scale indicate less anxiety.
2 secondary outcomes
Gross Motor Function Classification
Time frame: 36 week
Sociodemographic Form
Time frame: 36 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 3 Jun 2024.
- Derived from this study: PubMed 40099358Turhan A, Kurt-Aydin M, Tarsuslu T. Determinants of Gross Motor Function in Children With Ambulatory Spastic Cerebral Palsy: A Cross-Sectional Study in Turkey. J Paediatr Child Health. 2025 May;61(5):795-801. doi: 10.1111/jpc.70034. Epub 2025 Mar 18.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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?
An observational study of Cerebral Palsy and Family Characteristics, run by Kirsehir Ahi Evran Universitesi 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?
The sponsor lists 4 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 3 Jun 2024. 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?
Gross Motor Function Level (time frame: 36 week). The study lists 2 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 NCT06439446, 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 3 Jun 2024.