NCT05158634

Brief Summary

It is predicted by studies that the motor and cognitive performance disorders seen in children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility. At the same time, trunk muscle fatigue seen in children with CP is a critical motor problem and may cause deficits in adjusting the proper connection between the trunk and pelvis stabilizers.These deficits can lead to impairments in balance, postural control and mobility. Considering the relationship between the deficits seen in children with CP and postural control and postural control with the trunk, the idea that there is a need for studies that evaluate the trunk in every way and reveal its relationship with balance, postural control and mobility in order to organize the rehabilitation program effectively in children with CP. Therefore, in the planning of our study, it was aimed to evaluate trunk control and endurance in children with CP and to examine their relationship with balance and functional mobility parameters, as well as to reveal their relationship with functional health and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 21, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

January 14, 2025

Status Verified

December 1, 2023

Enrollment Period

29 days

First QC Date

November 21, 2021

Last Update Submit

January 12, 2025

Conditions

Keywords

Cerebral PalsyTrunk ControlMobilityBalanceFunctional HealthEndurance

Outcome Measures

Primary Outcomes (4)

  • Trunk Control Measurement Scale (TCMS)

    TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.

    Baseline

  • Pediatric Balance Scale (PBS)

    The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.

    Baseline

  • Time Up and Go (TUG)

    The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.

    Baseline

  • Trunk Endurance

    In the test performed to evaluate trunk endurance, the starting position is trunk flexed to 60 degrees (supported by a foam wedge), hips and knees flexed to 90 degrees, and feet in a stable position. In the test position, after the wedge is lifted, the participant is asked to try to keep the body in the flexion position at 60 degrees as much as possible and the time is recorded in seconds. The trunk endurance of the participants will be evaluated with the Trunk Flexor Test.

    Baseline

Secondary Outcomes (2)

  • Modified Push-up Test

    Baseline

  • Pediatric Outcomes Data Collection Instrument (PODCI)

    Baseline

Study Arms (1)

Cerebral Palsy

Inclusion Criterias: Being diagnosed with Cerebral Palsy. Volunteer. Be between the ages of 6-18. Being at level 1 and level 2 according to Gross Motor Function Classification System (GMFCS) (Level 1 and 2). To have the cognitive skills to understand and apply the evaluation parameters. Exclusion Criterias: Cognitive impairment of participants diagnosed with Cerebral Palsy. Participants diagnosed with Cerebral Palsy have vision or hearing problems. Participants diagnosed with Cerebral Palsy must have a history of trauma such as botox or muscle relaxation operation and/or fracture at least 6 months before participating in the study.

Other: Evaluations

Interventions

Within the scope of the study, the participants will be evaluated for 30 minutes in a single session. The participants' trunk stabilization and endurance, balance, functional mobility, upper extremity endurance, functional health and quality of life will be questioned by questionnaires, scales and tests. Evaluation will begin with a literature-supported demographic data form prepared for the participants. Assessments to be made are listed below. Trunk Control Measurement Scale (TCMS) Pediatric Balance Scale (PBS) Time Up and Go test (TUG) Trunk Flexor Test (TFT) The Pediatric Outcomes Data Collection Instrument (PODCI)

Cerebral Palsy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Being diagnosed with Cerebral Palsy. Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2). Be between the ages of 6-18.

You may qualify if:

  • Being diagnosed with Cerebral Palsy Volunteer Be between the ages of 6-18 Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2).
  • To have the cognitive skills to understand and apply the evaluation parameters.

You may not qualify if:

  • Participants diagnosed with Cerebral Palsy having cognitive disorders Participants diagnosed with Cerebral Palsy having vision or hearing problems Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Universitesi-Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

Location

Işıl Özel Eğitim ve Rehabilitasyon Merkezi

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayşe Asena Yekdaneh, Pt.,MSc.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2021

First Posted

December 15, 2021

Study Start

December 30, 2021

Primary Completion

January 28, 2022

Study Completion

February 20, 2022

Last Updated

January 14, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations