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

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

      • Kırşehir, Turkey
        • Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center

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
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.
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.
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.
36 week

Collaborators and Investigators

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

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

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.

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