- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149561
Evaluation of Communication Functions in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Bezmialem Vakif University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients whose parents agreed to participate in the study.
- Patients with confirmed cerebral palsy.
- Patients aged 2-18 years.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Communication Classification System(FCCS)
Time Frame: 6 month
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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.
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6 month
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Communication Function Classification System (CFCS)
Time Frame: 6 month
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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. |
6 month
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Gross Motor Function Classification System (GMFCS)
Time Frame: 6 month
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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.
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6 month
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Manual Ability Classification System (MACS)
Time Frame: 6 month
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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.
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6 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BVUFTRCP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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