NCT06679166

Brief Summary

The aim of this cross-sectional clinical study is to evaluate the frequency of falls in children diagnosed with cerebral palsy and compare it with healthy controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of falls

    This study aims to assess presence of falls)in children with cerebral palsy and compare it to healthy controls. By examining factors such as fall location, timing, injury occurrence, and rehabilitation status, the study seeks to identify specific fall risks and patterns in children with cerebral palsy. This data will provide insights for developing targeted interventions to reduce fall frequency and improve safety in this population.

    0 day

Study Arms (2)

Cerebral palsy

23 children aged 5-12 years diagnosed with cerebral palsy

Other: No intervention

Healthy children

A total of 23 children aged 5-12 years diagnosed with cerebral palsy and 23 healthy children without a diagnosis of cerebral palsy in the same age range will be included.

Other: No intervention

Interventions

No intervention

Cerebral palsyHealthy children

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Cerebral palsy and healthy volunteers

You may qualify if:

  • Children aged 5-12 years.
  • Diagnosed with cerebral palsy (study group) or healthy without cerebral palsy (control group).
  • Ability to ambulate either independently or with assistance indoors or in the community.
  • Consent obtained from the participant or their caregiver (parent or guardian).

You may not qualify if:

  • Refusal to participate in the study.
  • Presence of cognitive impairments.
  • Existence of neuromuscular diseases, other than cerebral palsy, that would impair walking ability or increase fall frequency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Büşra Şirin Ahısha, MD

CONTACT

Büşra Şirin Ahısha

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

November 10, 2024

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations