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CompletedNCT06439446Updated Jun 3, 2024

Functionality and Family Characteristics in Children With Cerebral Palsy

An observational study in Cerebral Palsy and Family Characteristics, sponsored by Kirsehir Ahi Evran Universitesi. Completed at 1 site in Turkey. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Kirsehir Ahi Evran Universitesi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
5 Years to 15 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cerebral Palsy
  • Family Characteristics

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Keywords

  • Functional Level
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 433 are open to participants now.

This study's enrollment of 68 is close to the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Gross Motor Function Level

    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.

    Time frame: 36 week

  2. Parents' Quality of Life

    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.

    Time frame: 36 week

Secondary outcomes

  1. Gross Motor Function Classification

    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.

    Time frame: 36 week

  2. Sociodemographic Form

    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.

    Time frame: 36 week

07

Study locations

1 site
  • Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
    Kırşehir, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06439446
Lead sponsor
Kirsehir Ahi Evran Universitesi
Responsible party
Atahan TURHAN (Principal Investigator, Dr. Lecturer, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Jun 3, 2024
Start date
Jun 6, 2023
Primary completion
May 5, 2024
Completion
May 25, 2024
Last update
Jun 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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