- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06583746
Lower Extremity Evaluation in Children With Diparetic Cerebral Palsy According to ICF Perspective
Cerebral palsy (CP); is the most common neurodevelopmental disorder seen in childhood, characterized by permanent motor dysfunctions that develop due to brain damage occurring before birth, during birth, or in early childhood.
The most common type is spastic type CP with a prevalence rate of 70-80%. Spastic type CP is divided into three groups as diparetic (38%), hemiparetic (39%) and quadriparetic (23%). In diparetic cerebral palsy (DCP); lower extremity involvement is more pronounced than upper extremity involvement. Typically; weakness in the trunk, postural and antigravity muscles, functional and/or structural asymmetry between both lower extremities are seen and this condition is closely related to impaired static and/or dynamic balance, decreased postural control, decreased functional performance, and low participation rate in activities.
The ICF (International Classification of Functioning, Disability, and Health) was developed by the World Health Organization in 2001 and is a comprehensive model that evaluates health status not only through the presence of diseases and disorders but also through various dimensions such as functionality, environmental, and personal factors. The ICF model includes five main components to evaluate an individual's functionality and disability: body structure and functions, activity, participation, environmental and personal factors. In recent years, functional abilities, including social participation, have increasingly become the focus of research in children with CP.
Study Overview
Status
Intervention / Treatment
Detailed Description
It's an observational study.
Purpose of the study: The increase in tone seen in the lower extremities in children with diparetic cerebral palsy (DCP) may adversely affect the activity and participation of children. Our study aim is to evaluate lower extremities in children with DCP according to ICF perspective.
A total of 30 cases, 15 females (50%) and 15 males (50%), aged between 3 and 13 years (mean: 5.8), who were admitted to the Pediatric Rehabilitation Department of Acıbadem Altunizade Hospital with the diagnosis of DCP between 2019 and 2022, were included in this cross-sectional study.
- What should the rehabilitation program for children with DCP include?
- What should we consider when evaluating children with DCP?
The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity, and Pediatric Functional Independence Measure (WeeFIM) was used for participation
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Acıbadem Altunizade Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between 3-13 years old,
- Diagnosis of diparetic cerebral palsy,
- Participants and/or parents willing to participate in the study voluntarily.
Exclusion Criteria:
- Having different types of CP such as dyskinetic, mixed, ataxic types other than spastic type,
- Having spastic quadriparetic or hemiparetic type CP,
- Having received Botulinum Toxin injections to the lower extremities within the last 6 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lower extremity evaluation of children with DCP within the framework of ICF
30 children with DCP were included.
The lower extremity evaluations of these cases were made according to ICF.
Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation.
|
30 children with DCP were included.
The lower extremity evaluations of these cases were made according to ICF.
Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale (MAS)
Time Frame: baseline
|
It is a 6-point scale used to describe the resistance of the muscle to passive movement and the ease with which the joint can be moved within the available range.
It is frequently used in clinical settings.
It is quite practical to evaluate and interpret.
|
baseline
|
|
Gillette Functional Walking Assessment Questionnaire (FAQ)
Time Frame: baseline
|
It is a measurement tool used to evaluate walking ability and functional mobility in children.
This questionnaire was developed specifically to evaluate the walking functions of children with cerebral palsy and other neuromuscular disorders.
Developed at Gillette Children's Hospital, this questionnaire aims to rate children's walking abilities in different environments.
It scores children's walking skills on a scale of 1-10.
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baseline
|
|
Pediatric Functional Independence Scale (WeeFIM)
Time Frame: baseline
|
The WeeFIM scale is a tool used to assess children's independence levels and functional abilities.
It was developed to objectively assess children's independence levels and whether they need assistance with daily living activities.
The scale consists of 6 main headings and 18 subheadings.
These subheadings evaluate areas such as self-care (feeding, dressing, toilet use), sphincter control, transfers (e.g.
bed, chair), movement (walking, wheelchair use), communication and social cognition (problem solving, memory).
Scoring ranges from 1 to 7, with the highest score being 126.
As the score increases, assistance decreases and independence increases.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IlaydaS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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