Fall Frequency in Children With Cerebral Palsy

November 6, 2024 updated by: Busra Sirin, Beylikduzu State Hospital

Evaluation of Fall Frequency in Children With Cerebral Palsy: A Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Our study is designed as a cross-sectional controlled study. A total of 23 children aged 5-12 years diagnosed with cerebral palsy, who can ambulate indoors or in the community either independently or with assistive devices, and 23 healthy children of the same age range will be included. Data will be collected on the age of the patients and healthy volunteers, information about their caregivers, frequency of falls, location and time of falls, education level, type of mobilization, presence of additional conditions, whether they receive rehabilitation, frequency of rehabilitation, duration of hospitalization if applicable, occurrence of falls during hospitalization, and presence of injuries. The collected data will be compared with the healthy controls.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Büşra Şirin Ahısha, MD
  • Phone Number: 02124443322
  • Email: bsrn080@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Beylikdüzü State Hospital

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

Yes

Sampling Method

Probability Sample

Study Population

Cerebral palsy and healthy volunteers

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cerebral palsy
23 children aged 5-12 years diagnosed with cerebral palsy
Other: No intervention
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of falls
Time Frame: 0 day
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

Collaborators and Investigators

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

Sponsor

Beylikduzu State Hospital

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 (Estimated)

November 10, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeylikduzuStateH10

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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