- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06679166
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
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
- Name: Büşra Şirin Ahısha
- Phone Number: 02124443322
- Email: bsrn080@gmail.com
Study Locations
-
-
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Istanbul, Turkey, 34147
- Beylikduzu State Hospital
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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
|
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.
|
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
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.