NCT06378723

Brief Summary

The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

February 14, 2024

Last Update Submit

January 31, 2026

Conditions

Keywords

cerebral palsyupper extremitytrunk controlfunctionalitybalance

Outcome Measures

Primary Outcomes (4)

  • trunk control

    All the children will be measured with the Trunk Control Measurement Scale. This test includes 15 items that measure static and dynamic sitting balance, two components of trunk control during functional activities. All items are scored on 2, 3 or 4 points and are administered bilaterally. The total score is between 0-58. A high score indicates good performance.

    one month

  • upper extremity functionality

    All the children will be measured with the Quality of upper extremity skills test. This test evaluates the quality of upper extremity movements; It evaluates in 4 different areas: independent movements, grasping, weight bearing and protective extension. In protective extension, falling to the front, back and side using the arms is evaluated. A "yes" or "no" score is given depending on the completion of each action or task. Scores in these four areas are added together for a total score. Additionally, hand function, spasticity and cooperation are also evaluated. In hand function evaluation, 0 to 10 points are marked for the right hand, left hand and bilaterally. In cooperation, children's cooperation statuses are marked as "not cooperative", "partially cooperative" and "fully cooperative". During the evaluation, the child is not allowed to use any devices for the upper extremity. Both the child's right and left upper extremities are scored separately. Total score is between 0 and 100.

    one month

  • balance

    all the children will be measured with the Four Step Square Test and Single leg Stance test. It is desirable to maintain this posture for as long as possible during the test. The test and duration begin with the foot being lifted off the ground. The test is repeated twice and the best time measured is noted in seconds (for single leg stance). The test begins with one foot of the individual touching the ground in the 2nd square and ends with the last foot touching the ground in the 1st square. The test is repeated twice for each individual and the test score completed in the shortest time is recorded in seconds (four step square test).

    one month

  • Weight and Height

    Weight and height will be combined to report BMI in kg/m2

    one month

Study Arms (2)

Healthy Children

Healthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders.

Other: Balance Tests

Cerebral Palsy Children

Cerebral Palsy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with Gross Motor Function Classification levels 1 and 2 will be included in the study.

Other: Balance Tests

Interventions

With the scales and tests the children trunk control, quality of upper extremity skills, single leg stance duration will be measured

Cerebral Palsy ChildrenHealthy Children

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cerebral Palsy and healthy children between the ages of 8 and 18 will be included in the study. Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders. In order to standardize their mobility, those with GMFC levels 1 and 2 will be included in the study.

You may qualify if:

  • Between the ages of 8-18,
  • Gross Motor Function Classification System level 1-2,
  • Do not have severe visual or hearing impairment,
  • Does not have any cooperation problems that would hinder communication,
  • Children who have had Botulinum Toxin-A injection

You may not qualify if:

  • Those with GMFC level 3-4-5,
  • Children who had surgery within the last six months were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi

Adana, Çukurova, 01170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emine Tuzun, Prof

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator PhD Physiotherapist Burcin Ugur Tosun

Study Record Dates

First Submitted

February 14, 2024

First Posted

April 22, 2024

Study Start

February 1, 2024

Primary Completion

April 15, 2024

Study Completion

April 16, 2024

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations