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Completed

NCT Number: NCT06439446

Functionality and Family Characteristics in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Family Characteristics Nervous System Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center

Kırşehir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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