- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06591689
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
Completed
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
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Istanbul, Turkey
- Acıbadem Altunizade Hospital
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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
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
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
|
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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
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)
January 1, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
August 31, 2024
Study Registration Dates
First Submitted
September 7, 2024
First Submitted That Met QC Criteria
September 7, 2024
First Posted (Estimated)
September 11, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 12, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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