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Completed

NCT Number: NCT06585397

ICF-Based Evaluation of the Upper Extremity in Children With Quadriparetic Cerebral Palsy

Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Spastic CP accounts for approximately 85% of all CP cases. Among the types of spastic CP, quadriparetic CP (QCP) is the most severe and accounts for 20% of spastic CP cases. Individuals diagnosed with quadriparetic cerebral palsy (QCP) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). In order to correctly evaluate children diagnosed with QCP and determine treatment priorities, it is very important to evaluate them based on the International Classification of Functioning, Disability, and Health (ICF). In the literature, there is no study that evaluates the upper extremity of individuals with isolated QCP based on ICF. The aim of this study is to examine the upper extremity functions of individuals with isolated QCP diagnosis within the framework of ICF.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Altunizade Hospital

Istanbul, AA, 34662, Turkey (Türkiye)

About this study

It is an observational study. Purpose of the study: To examine the upper extremity functions of individuals with an isolated diagnosis of quadriparetic Cerebral Palsy (QCP) within the framework of ICF.

Participants: Children with quadriparetic CP between the ages of 0-17.

Questions:

  • What is the relationship between upper extremity spasticity and manual dexterity in children with QCP?
  • What is the relationship between manual skills and activities of daily living in children with QCP?

The upper extremities of the patients with QCP will be evaluated within the framework of ICF. Body structure and functions will be evaluated with the Modified Ashworth Scale (MAS), activities with the Manual Ability Classification System (MACS), and participation with the Functional Independence Measure for Children (WeeFIM). The evaluations will be made by physiotherapists experienced in children with CP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age of the cases is between 0-17,
  • They have been diagnosed with quadriparetic CP,
  • The participants and parents want to participate in the study voluntarily.

Exclusion criteria

  • Having different types of CP such as dyskinetic, ataxic and mixed type,
  • Having spastic diparetic or hemiparetic type CP,
  • Having any history of surgery on the musculoskeletal system,
  • Having received Botulinum Toxin injection within the last 6 months.

Treatment and study plan

Grup 1

Other

Within the framework of ICF, the Modified Ashworth Scale, the Manual Ability Classification System and the Functional Independence Measure for Children will be applied to 20 quadriparetic children with CP.

Primary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: baseline

    It is a 6-point scale that measures the resistance of the muscle to passive movement by passively moving it through the normal range of motion of the joint. Within the scope of the study, the upper extremity muscles; shoulder flexors, shoulder extensors, elbow flexors, elbow extensors, forearm pronators, wrist flexors, wrist extensors, and fingers will be evaluated with MAS.

  2. Manual Ability Classification System (MACS)

    Time frame: baseline

    It is used to classify how children with CP use their hands to handle objects in daily activities. The MACS identifies 5 levels. The MACS levels are functional descriptions based on a child's usual, self-initiated ability to handle objects in daily activities. The levels are based on children's ability to handle objects independently and their need for assistance or adaptations to perform manual activities in daily life.

  3. Functional Independence Measure for Children (WeeFIM)

    Time frame: baseline

    It was developed to assess the functional independence levels of children with developmental disabilities in their daily living activities. The scale consists of 6 sections: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), and social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored from 1 to 7. 1 point indicates full dependency; 7 points indicate full independence. A total of 18 (full dependency) points and a maximum of 126 (full independence) points can be obtained.

Sponsors and collaborators

Lead sponsor

Acıbadem Atunizade Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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