NCT06583746

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 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

January 1, 2002

Completed
20.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

20.1 years

First QC Date

September 2, 2024

Last Update Submit

September 2, 2024

Conditions

Keywords

Diparetic Cerebral PalsyLower extremityInternational Classification of FunctionBody structure and functionActivityParticipation

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale (MAS)

    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)

    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.

    baseline

  • Pediatric Functional Independence Scale (WeeFIM)

    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

Study Arms (1)

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.

Other: Group1

Interventions

Group1OTHER

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.

Lower extremity evaluation of children with DCP within the framework of ICF

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children diagnosed with diparetic cerebral palsy between the ages of 3 and 13 were included.

You may qualify if:

  • Between 3-13 years old,
  • Diagnosis of diparetic cerebral palsy,
  • Participants and/or parents willing to participate in the study voluntarily.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyParesisMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

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

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 4, 2024

Study Start

January 1, 2002

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

September 4, 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