Relationship Between Communication and Gross Motor Function in Quadriparetic Cerebral Palsy

September 12, 2024 updated by: Ali Demir, Acıbadem Atunizade Hospital

Investigation of the Relationship Between Communication Function and Gross Motor Function in Patients With Quadriparetic Cerebral Palsy

Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is an observational study conducted with data obtained from assessment scales and does not involve any treatment. The target population of the study consists of individuals diagnosed with quadriparetic cerebral palsy (QCP). Individuals with QCP aged 0-17 years were included in the study. Detailed medical histories were taken from the participants, and they were evaluated using the Communication Function Classification System (CFCS), the Pediatric Functional Independence Measure (WeeFIM), and the Gross Motor Function Measure-88 (GMFM-88). The aim of this study is to examine the effect of communication function on gross motor function and independence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Acıbadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Twenty quadriparetic cerebral palsy individuals between the ages of 0-17 were included in the study.

Description

Inclusion Criteria:

  • Ages between 0-17,
  • Diagnosed with quadriparetic cerebral palsy,
  • Participants and parents willing to participate in the study voluntarily.

Exclusion Criteria:

  • Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
  • Having spastic diparetic or hemiparetic type cerebral palsy,
  • Having any history of surgery on the musculoskeletal system,
  • Having received Botulinum Toxin injections in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Communication Function Classification System (CFCS)
Time Frame: 1 month
The communication functions of patients were evaluated using the "Communication Function Classification System (CFCS)." CFCS assesses the daily communication performance of individuals with cerebral palsy (CP) across five levels. It evaluates all methods that affect communication performance, such as speech, facial expressions, gestures, eye contact, facial cues, and the use of augmentative and alternative communication methods. In CFCS, Level I indicates a better condition, while Level V represents more impaired situations.
1 month
The Pediatric Functional Independence Measure (WeeFIM)
Time Frame: 1 month
The Pediatric Functional Independence Measure (WeeFIM) is a useful, brief, and comprehensive assessment method for identifying the functional limitations of children with developmental disorders. It consists of 18 items under the categories of self-care, sphincter control, transfers, mobility, communication, and social interaction. Each item is scored between 1 and 7. A child receives a score of 1 when performing an item with full assistance, and a score of 7 when completing it independently, safely, and in a timely manner. Afterwards, all scores are summed to calculate a percentage of independence. The WeeFIM assessments were carried out by physiotherapists based on information obtained from families. High scores on this scale indicate a high level of independence.
1 month
The Gross Motor Function Measure-88 (GMFM-88)
Time Frame: 1 month
The Gross Motor Function Measure-88 (GMFM-88) was used to determine the functional performance of children. GMFM-88 is a standardized, validated observational scale, and it is mandatory to use the user manual for scoring each item. GMFM-88 evaluates five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking. Each section is assessed individually, and a percentage score is calculated. The total score is obtained by averaging the percentage scores of the five sections. The items in the sections are scored as 0, 1, 2, or 3. The GMFM-88 scores were calculated by physiotherapists in strict adherence to the user manual. Total GMFM-88 score is evaluated out of 100, and higher scores indicate good gross motor development.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acıbadem Atunizade Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ali Demir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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