Cerebral PalsyNCT04149561
Evaluation of Communication Functions in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aimed to evaluate the communication functions of children between 2-18 with cerebral palsy. Investigators planned to investigate the relationship between communication skills and clinical characteristics and socio-demographic status of the family. 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?
- communication skill measurement with self report questionnaire
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 14 Mar 2020
- 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: 100 patients aged 2-18 years with cerebral palsy.
Who may be able to join
- Patients whose parents agreed to participate in the study.
- Patients with confirmed cerebral palsy.
- Patients aged 2-18 years.
Who cannot join
- Patients without definite cerebral palsy.
- Patients whose family refused to participate in the study.
- Patients with another neurological disorder that may affect their physical and neurological capacity.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, investigators aimed to evaluate the communication functions of children between 2-18 with cerebral palsy. Investigators planned to investigate the relationship between communication skills and clinical characteristics and socio-demographic status of the family.
Read the detailed description
Cerebral palsy (CP) is a non-progressive, movement-limiting loss of permanent motor function, posture and movement disturbance in the developing brain due to lesion or injury that occurs during the intrauterine period or in the first months of life. Secondary medical problems such as epilepsy, mental retardation, behavior disorder, swallowing problems and musculoskeletal disorders may be seen in these patients. Neuroanatomical problems in the muscles associated with the mouth and speech, and the presence of central pathologies, are important problems in patients with cerebral palsy. Monitoring the communication level of these patients is very important for determining treatment protocols and monitoring their effectiveness. Difficulties in communication significantly affect the rate and level of recovery in patients with cerebral palsy. There are many different scales to analyze communication level and problems in children with cerebral palsy. The most commonly used ones are the Communication Function Classification System (CFCS) and the Functional Communication Classification System (FCCS). By examining the communication level in 5 categories in both scales, it helps to monitor the communicative development of the child and also provides a common language among clinicians. They are defined by the World Health Organization (WHO) and focus on the levels of activity and participation defined in the international classification of function, disability and health.
The aim of this study was to evaluate the communication level in children over 2 years of age with cerebral palsy. In addition, the relationship between communication skills and general functional levels and demographic characteristics will be investigated. In this way, both the general communication level of this patient group and the possible factors affecting this skill will be analyzed. Thus, these relationships and measurements can be utilized in determining treatment and rehabilitation protocols.
- Conditions
- Cerebral Palsy
- Being tested
- communication skill measurement with self report questionnaire
- Keywords
- cerebral palsy, communication
- Medical subject headings
- Cerebral Palsy, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication skill measurement with self report questionnaireOther
Demographic information form, Communication Function Classification System, Functional Communication Classification System, The Gross Motor Function Classification System and Manual Ability Classification System will be filled in for the patients.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy | 100 patients over 2 years of age with a diagnosis of cerebral palsy will be included in the study. Demographic information form prepared for the study in terms of demographic information such as age, gender, clinical type of cerebral palsy, drugs used, comorbid diseases will be completed. Communication Function Classification System and Functional Communication Classification System will be used to evaluate patients' communication skills. In addition, patients; The Gross Motor Function Classification System for cerebral palsy and based on child-initiated movements with emphasis on sitting, displacement and mobility, and to hold objects during the daily activities of children with cerebral palsy. The Manual Ability Classification System, which classifies how they use their hands, will also be completed. Receives: Other: communication skill measurement with self report questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Communication Classification System(FCCS)
The Functional Communication Classification System was designed to classify how children with cerebral palsy between the ages of four and five communicate on a daily basis. The tool focuses on how children typically communicate with familiar and unfamiliar communication partners. There are five classifications a child can be categorized in: (1) effective communicator in most situations (2) effective communicator in most situations, but does need some help (3) an effective communicator in most situations and can communicate small ranges of messages and topics to most familiar people (4) assistance is required in most situations, especially with unfamiliar people and environments. Communicates daily needs and wants to familiar people (5) communicates using undirected movement, vocalisation and/or behaviour, for interpretation by familiar people.
Measured: 6 month
Communication Function Classification System (CFCS)
The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication. It consists of five levels which describe everyday communication ability.
Classification on the CFCS is made by a person who is familiar with the individual's communication in everyday situations.
Classification is based on the effectiveness of communication between a sender and receiver of information.
CFCS considers the familiarity of a person's communication partners.
All ways of communicating are considered including speech, gesture, facial expression and augmentative and alternative communication.
A person classified at Level I is a more able communicator than a person classified at Level V.
Measured: 6 month
Gross Motor Function Classification System (GMFCS)
The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. The distinctions between Levels I and II are not as pronounced as the distinctions between the other levels, particularly for infants less than 2 years of age.
Measured: 6 month
Manual Ability Classification System (MACS)
The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Nov 2019
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
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.
- More trials run by Bezmialem Vakif UniversityThe 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
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149561
- Sponsor's protocol ID
- BVUFTRCP1
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Communication Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04149561
- Acronym / sponsor ID
- BVUFTRCP1
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 4 Nov 2019 (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.
In this study, investigators aimed to evaluate the communication functions of children between 2-18 with cerebral palsy. Investigators planned to investigate the relationship between communication skills and clinical characteristics and socio-demographic status of the family.
Detailed description
Cerebral palsy (CP) is a non-progressive, movement-limiting loss of permanent motor function, posture and movement disturbance in the developing brain due to lesion or injury that occurs during the intrauterine period or in the first months of life. Secondary medical problems such as epilepsy, mental retardation, behavior disorder, swallowing problems and musculoskeletal disorders may be seen in these patients. Neuroanatomical problems in the muscles associated with the mouth and speech, and the presence of central pathologies, are important problems in patients with cerebral palsy. Monitoring the communication level of these patients is very important for determining treatment protocols and monitoring their effectiveness. Difficulties in communication significantly affect the rate and level of recovery in patients with cerebral palsy. There are many different scales to analyze communication level and problems in children with cerebral palsy. The most commonly used ones are the Communication Function Classification System (CFCS) and the Functional Communication Classification System (FCCS). By examining the communication level in 5 categories in both scales, it helps to monitor the communicative development of the child and also provides a common language among clinicians. They are defined by the World Health Organization (WHO) and focus on the levels of activity and participation defined in the international classification of function, disability and health.
The aim of this study was to evaluate the communication level in children over 2 years of age with cerebral palsy. In addition, the relationship between communication skills and general functional levels and demographic characteristics will be investigated. In this way, both the general communication level of this patient group and the possible factors affecting this skill will be analyzed. Thus, these relationships and measurements can be utilized in determining treatment and rehabilitation protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy | – | Other: communication skill measurement with self report questionnaire100 patients over 2 years of age with a diagnosis of cerebral palsy will be included in the study. Demographic information form prepared for the study in terms of demographic information such as age, gender, clinical type of cerebral palsy, drugs used, comorbid diseases will be completed. Communication Function Classification System and Functional Communication Classification System will be used to evaluate patients' communication skills. In addition, patients; The Gross Motor Function Classification System for cerebral palsy and based on child-initiated movements with emphasis on sitting, displacement and mobility, and to hold objects during the daily activities of children with cerebral palsy. The Manual Ability Classification System, which classifies how they use their hands, will also be completed. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 patients aged 2-18 years with cerebral palsy.
Key inclusion criteria (3 listed)
- Patients whose parents agreed to participate in the study.
- Patients with confirmed cerebral palsy.
- Patients aged 2-18 years.
Key exclusion criteria (3 listed)
- Patients without definite cerebral palsy.
- Patients whose family refused to participate in the study.
- Patients with another neurological disorder that may affect their physical and neurological capacity.
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 |
|---|---|---|
| communication skill measurement with self report questionnaireDemographic information form, Communication Function Classification System, Functional Communication Classification System, The Gross Motor Function Classification System and Manual Ability Classification System will be filled in for the patients. | Other | Cerebral Palsy |
Primary outcome
Functional Communication Classification System(FCCS)
Time frame: 6 month
The Functional Communication Classification System was designed to classify how children with cerebral palsy between the ages of four and five communicate on a daily basis. The tool focuses on how children typically communicate with familiar and unfamiliar communication partners. There are five classifications a child can be categorized in: (1) effective communicator in most situations (2) effective communicator in most situations, but does need some help (3) an effective communicator in most situations and can communicate small ranges of messages and topics to most familiar people (4) assistance is required in most situations, especially with unfamiliar people and environments. Communicates daily needs and wants to familiar people (5) communicates using undirected movement, vocalisation and/or behaviour, for interpretation by familiar people.
Communication Function Classification System (CFCS)
Time frame: 6 month
The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication. It consists of five levels which describe everyday communication ability. Classification on the CFCS is made by a person who is familiar with the individual's communication in everyday situations. Classification is based on the effectiveness of communication between a sender and receiver of information. CFCS considers the familiarity of a person's communication partners. All ways of communicating are considered including speech, gesture, facial expression and augmentative and alternative communication. A person classified at Level I is a more able communicator than a person classified at Level V.
Gross Motor Function Classification System (GMFCS)
Time frame: 6 month
The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. The distinctions between Levels I and II are not as pronounced as the distinctions between the other levels, particularly for infants less than 2 years of age.
Manual Ability Classification System (MACS)
Time frame: 6 month
The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life.
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 17 Mar 2020.
- 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?
An observational study of Cerebral Palsy, run by Bezmialem Vakif 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 3 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 17 Mar 2020. 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?
Functional Communication Classification System(FCCS) (time frame: 6 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 17 Mar 2020.