NCT06439446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 28, 2024

Last Update Submit

May 31, 2024

Conditions

Keywords

Functional Level

Outcome Measures

Primary Outcomes (2)

  • 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.

    36 week

  • 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.

    36 week

Secondary Outcomes (2)

  • Gross Motor Function Classification

    36 week

  • Sociodemographic Form

    36 week

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosed with hemiparetic and diparetic type CP
  • Between the ages of 5-15
  • GMFCS level I, II and III
  • Volunteer individuals were included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center

Kırşehir, Turkey (Türkiye)

Location

Related Publications (1)

  • Turhan A, Kurt-Aydin M, Tarsuslu T. Determinants of Gross Motor Function in Children With Ambulatory Spastic Cerebral Palsy: A Cross-Sectional Study in Turkey. J Paediatr Child Health. 2025 May;61(5):795-801. doi: 10.1111/jpc.70034. Epub 2025 Mar 18.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Dr. Lecturer

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

June 6, 2023

Primary Completion

May 5, 2024

Study Completion

May 25, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations