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Cerebral PalsyPLCCNCT03191695

Participation to Life of Children With Cerebral Palsy

An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Assessment via questionnaire
How many people
500 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2018to Jan 2020
How long will I take part?
1 Day
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 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The subjects will be recruited from children who lives in Ankara city and, attend special education centers.

Who may be able to join

  • To be diagnosed as cerebral palsy

Who cannot join

  • Children whose family didn't accept to participate to study

Trial locations and contacts

1 site in 1 country.

Mintaze KEREM GÜNEL contact

+905327164221

mintaze@yahoo.com

Ayşe Numanoğlu Akbaş contact

+905058644036

aysenumanoglu@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Hacettepe University

    Ankara

    Mintaze Kerem Günel

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Investigation of Necessity, Participation to Life of Children With Cerebral Palsy and Their Families

Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development. Motor problems in CP are usually accompanied by sensory and perceptual disorders, cognitive disorders, communication and behavioral disorders, epilepsy, and secondary musculoskeletal system problems. The first 20 years of life is characterized by rapid growth and specific changes in physical, social, and psychological development. Social participation and independence of children and youth are related to the changes in this period. Participation can be identified as being involved in life situations and it reflects the social aspect of functionality. The problems which can be come across in life situations are identified as participation limitation. In literature, no adequate study has investigated the functional inadequacy, activity and participation of children with CP; this project has been planned in order to specify the importance in rehabilitation interventions more detailed. This project aims to specify whether the functional levels correspond to the activity and participation limitations of children with CP living in Ankara city center and determine the effects of their functional status on activity, participation and quality of life. This investigation will be pioneer in indicating the activity and participation limitations of children with CP. According to the results, these limitations will be overcome and the quality of life of children with CP will be increased. The CP follow-up database in Ankara will be specified so their physical activity and participation levels will be followed periodically and CP profile will be determined in Ankara.

Read the detailed description

Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development.The first 20 years of life is characterized by rapid growth and specific changes in physical, social, and psychological development. Social participation and independence of children and youth are related to the changes in this period. Participation can be identified as being involved in life situations and it reflects the social aspect of functionality. The problems which can be come across in life situations are identified as participation limitation. In the past, the impairment seen in child was concentrated and child was the passive receptor of treatment. Today, this view is changed and child is the active participant of the treatment of disability. The aim of treatment is identified as increasing the quality of life by supporting the activity and participation according to the priorities of the child and the parent.

In literature, no adequate study has investigated the functional inadequacy, activity and participation of children with CP; this project has been planned in order to specify the importance in rehabilitation interventions more detailed. This project aims to specify whether the functional levels correspond to the activity and participation limitations of children with CP living in Ankara city center and determine the effects of their functional status on activity, participation and quality of life. This investigation will be pioneer in indicating the activity and participation limitations of children with CP. According to the results, these limitations will be overcome and the quality of life of children with CP will be increased. The CP follow-up database in Ankara will be specified so their physical activity and participation levels will be followed periodically and CP profile will be determined in Ankara. Moreover, the results of this study will be shared with the Ministry of National Education, the Ministry of Family and Social Policies, and the Ministry of Health and this will bring a different viewpoint to the community-based rehabilitation services in Turkey. Furthermore, this study will be expected to motivate countrywide investigations.

In the project, Gross Motor Function Classification System (GMFCS) for the severity of the disability of people with CP, The Measure of Processes of Care (MPOC) for their care process, the Pediatric Outcomes Date Collection (PODCI) Instrument and Pediatric Quality of Life Questionnaire and The Child Health Quality (CHQ PF-50) for their health-related quality of life, the Manual Ability Classification System (MACS) for the manual abilities and the Communication Function Classification System (CFCS) for the communication skill and the Life Habits Questionnaire (LIFE-H) for the participation level and Impact on Family Scale (IPFAM) for family impact will be used and the outcomes will be analyzed by adequate statistical methods. It is intended to be discussed the findings of the project in national and international platforms.

Conditions
Cerebral Palsy
Being tested
Assessment via questionnaire
Keywords
Participation, Activity, Cerebral Palsy, LIFE Habits (life-H), Gross Motor Function, Health-related Quality of Life, Family
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment via questionnaireOther

    All the children will be assessed via assessment questionnaires.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life Habits Questionnaire (LIFE-H)

    Assessing of the participation level of children

    Measured: At baseline

Secondary outcomes (9)

  1. Gross Motor Function Classification System (GMFCS)

    Assessing severity of the disability of children

    Measured: At baseline

  2. Pediatric Outcomes Date Collection (PODCI) (Questionnaire)

    Assessing health-related quality of life of children by parent proxy questionnaire

    Measured: At baseline

  3. Manual Ability Classification System (MACS)

    Assessing the manual abilities

    Measured: At baseline

  4. Communication Function Classification System (CFCS)

    Assessing communication skill

    Measured: At baseline

  5. The Child Health Quality (CHQ PF-50)

    Assessing health-related quality of life

    Measured: At baseline

  6. Pediatric Quality of Life Questionnaire (PedsQL)

    Assessing health-related quality of life

    Measured: At baseline

  7. The Measure of Processes of Care (MPOC) (Questionnaire)

    Assessing health care process of children by parent proxy questionnaire

    Measured: At baseline

  8. Impact on Family Scale (IPFAM)

    Assessing family impact

    Measured: At baseline

  9. Pediatric Evaluation of Disability Inventory

    Assessing disability

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start1 Feb 2018
  3. Primary completionOct 2018 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191695
Sponsor's protocol ID
116S359-1
Acronym
PLCC
Status last verified
Aug 2018
First submitted
16 Jun 2017
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Himuro N, Kozuka N, Mori M. Measurement of family-centred care: translation, adaptation and validation of the Measure of Processes of Care (MPOC-56 and -20) for use in Japan. Child Care Health Dev. 2013 May;39(3):358-65. doi: 10.1111/j.1365-2214.2012.01371.x. Epub 2012 Feb 28.

    PubMed 22372945

  • Bodkin AW, Robinson C, Perales FP. Reliability and validity of the gross motor function classification system for cerebral palsy. Pediatr Phys Ther. 2003 Winter;15(4):247-52. doi: 10.1097/01.PEP.0000096384.19136.02.

    PubMed 17057460

  • Berg M, Jahnsen R, Froslie KF, Hussain A. Reliability of the Pediatric Evaluation of Disability Inventory (PEDI). Phys Occup Ther Pediatr. 2004;24(3):61-77. doi: 10.1300/j006v24n03_05.

    PubMed 15257969

  • Damiano DL, Gilgannon MD, Abel MF. Responsiveness and uniqueness of the pediatric outcomes data collection instrument compared to the gross motor function measure for measuring orthopaedic and neurosurgical outcomes in cerebral palsy. J Pediatr Orthop. 2005 Sep-Oct;25(5):641-5. doi: 10.1097/01.bpo.0000167079.83835.22.

    PubMed 16199947

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by Hacettepe 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 1 inclusion and 1 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 28 Aug 2018. 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?

Contact Mintaze KEREM GÜNEL (+905327164221, mintaze@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life Habits Questionnaire (LIFE-H) (time frame: At baseline). 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 NCT03191695, which also lists 4 linked publications.

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 28 Aug 2018.

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