NCT04149561

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

October 31, 2019

Last Update Submit

March 16, 2020

Conditions

Keywords

cerebral palsycommunication

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    6 month

Study Arms (1)

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.

Other: communication skill measurement with self report questionnaire

Interventions

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.

Cerebral Palsy

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 patients aged 2-18 years with cerebral palsy.

You may qualify if:

  • Patients whose parents agreed to participate in the study.
  • Patients with confirmed cerebral palsy.
  • Patients aged 2-18 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif university

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyCommunication

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

November 1, 2019

Primary Completion

March 14, 2020

Study Completion

March 14, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations