Evaluation of Communication Functions in Children With Cerebral Palsy

NCT ID: NCT04149561

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

communication skill measurement with self report questionnaire

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

communication skill measurement with self report questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem Vakif university

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BVUFTRCP1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.