NCT06585397

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

September 3, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

ICFBody structure and functionActivityparticipationcerebral palsyupper extremity

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale (MAS)

    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.

    baseline

  • Manual Ability Classification System (MACS)

    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.

    baseline

  • Functional Independence Measure for Children (WeeFIM)

    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.

    baseline

Study Arms (1)

Upper extremity evaluation of children with quadriparetic CP

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.

Other: Grup 1

Interventions

Grup 1OTHER

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.

Upper extremity evaluation of children with quadriparetic CP

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Twenty quadriparetic children with CP, aged 0-17 years, will be included in the study for upper extremity evaluation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, AA, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityCerebral Palsy

Condition Hierarchy (Ancestors)

BehaviorBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Neslihan Yıldızdağı

    Acıbadem Atunizade Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 5, 2024

Study Start

August 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations