- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06439446
Functionality and Family Characteristics in Children With Cerebral Palsy
May 31, 2024 updated by: Atahan TURHAN, Kirsehir Ahi Evran Universitesi
The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability
The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
68
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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Kırşehir, Turkey
- Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
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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
This study was carried out at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center.
Patients who applied to the Physical Medicine and Rehabilitation Polyclinic with the diagnosis of CP were examined by a physical therapist.
Parents of children who met the inclusion criteria were interviewed and informed about the study.
Description
Inclusion Criteria:
- Diagnosed with hemiparetic and diparetic type CP
- Between the ages of 5-15
- GMFCS level I, II and III
- Volunteer individuals were included.
Exclusion Criteria:
- Having undergone a surgical operation within the last year,
- Having contracture in the lower extremity,
- Having had a fracture in the lower extremity in the last 6 months,
- Botulinum Toxin A (BTX-A) administered in the last 6 months
- Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from the study.
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 |
|---|---|---|
|
Gross Motor Function Level
Time Frame: 36 week
|
Gross motor function level was measured with Gross Motor Function Measure-66 (GMFM-66).
GMFM-66 is a 66-item test developed to measure gross motor skills in children with cerebral palsy and can be evaluated in 5 different categories, including reaching and rolling, sitting, crawling and crawling, standing, walking, running and jumping.
It is a 4-point Likert type scale.
Higher scores on the test indicate higher gross motor skills.
|
36 week
|
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Parents' Quality of Life
Time Frame: 36 week
|
Parents' self-reported quality of life functions such as physical, emotional, social, and cognitive were assessed with The PedsQL Family Impact Module.
Total score range is 0-100.
Higher scores on the scale indicate less anxiety.
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36 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Classification
Time Frame: 36 week
|
Gross motor functional classification was evaluated with the Gross Motor Function Classification System (GMFCS).
GMFCS classifies children with Cerebral Palsy into 5 levels (1-5) based on their motor skills, functional abilities, assistive technologies, and wheelchair needs.
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36 week
|
|
Sociodemographic Form
Time Frame: 36 week
|
Characteristic information about the family, such as the family's average monthly income, the number of people living in the family, and the region in which the family lived, was collected.
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36 week
|
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)
June 6, 2023
Primary Completion (Actual)
May 5, 2024
Study Completion (Actual)
May 25, 2024
Study Registration Dates
First Submitted
May 28, 2024
First Submitted That Met QC Criteria
May 31, 2024
First Posted (Actual)
June 3, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEU-T.ATAHAN-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.