Children With Cerebral PalsyNCT05229757
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
A study testing Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. and Family-based home exercise. in people with Children With Cerebral Palsy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Children With Cerebral Palsy
- What is being tested?
- Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. and Family-based home exercise.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2021to 30 Apr 2022
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be in the age range of 3-18 years.
- Getting a diagnosis of cerebral palsy.
- Agree to participate in the study.
Who cannot join
- If the child interrupts supportive education for any reason,
- Failure of the family to ensure continuity in participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Şahinbey, 27000
About this study
The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.
The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.
- Conditions
- Children With Cerebral Palsy
- Being tested
- Physiotherapy and rehabilitation treatment in a special education and rehabilitation center., Family-based home exercise.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.Other
Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
Family-based home exercise.Other
Home exercise was applied by the families every day of the week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Receives: Other: Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. |
| Control Group | Active comparator | Individuals in the control group were followed with a home program for 8 weeks. Receives: Other: Family-based home exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abilhand Kids (For patients)
It is a questionnaire consisting of 21 questions designed to test children's manual abilities. The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.
Measured: Change from Baseline Abilhand Kids at 8 weeks.
GMFM 66 (For patients)
Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
Measured: Change from Baseline GMFM 66 at 8 weeks.
PEDI (For patients)
It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.
Measured: Change from Baseline PEDI at 8 weeks.
Beck Depression Scale (For family)
It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions. According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.
Measured: Change from Baseline Beck Depression Scale at 8 weeks.
IPFAM (For family)
The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions. Makes classification according to the total score.
Measured: Change from Baseline IPFAM at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start19 May 2021
- Primary completion31 Dec 2021
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ergun Kayiran, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229757
- Sponsor's protocol ID
- 2021/048
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05229757
- Acronym / sponsor ID
- 2021/048
- Conditions
- Children With Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 8 Feb 2022 (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 activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.
The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. |
| Control Group | Active comparator | Other: Family-based home exercise.Individuals in the control group were followed with a home program for 8 weeks. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Be in the age range of 3-18 years.
- Getting a diagnosis of cerebral palsy.
- Agree to participate in the study.
Key exclusion criteria (2 listed)
- If the child interrupts supportive education for any reason,
- Failure of the family to ensure continuity in participation
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 |
|---|---|---|
| Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center. | Other | Study Group |
| Family-based home exercise.Home exercise was applied by the families every day of the week for 8 weeks. | Other | Control Group |
Primary outcome
Abilhand Kids (For patients)
Time frame: Change from Baseline Abilhand Kids at 8 weeks.
It is a questionnaire consisting of 21 questions designed to test children's manual abilities. The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.
GMFM 66 (For patients)
Time frame: Change from Baseline GMFM 66 at 8 weeks.
Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
PEDI (For patients)
Time frame: Change from Baseline PEDI at 8 weeks.
It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.
Beck Depression Scale (For family)
Time frame: Change from Baseline Beck Depression Scale at 8 weeks.
It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions. According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.
IPFAM (For family)
Time frame: Change from Baseline IPFAM at 8 weeks.
The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions. Makes classification according to the total score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- 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 Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. and Family-based home exercise. in people with Children With Cerebral Palsy, run by Hasan Kalyoncu 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?
The sponsor lists 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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?
Results are not available in the source record.
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?
Abilhand Kids (For patients) (time frame: Change from Baseline Abilhand Kids at 8 weeks.). The study lists 5 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 8 Feb 2022.