NCT06343701

Brief Summary

The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:

  • There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.
  • There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.
  • There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.
  • There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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

July 18, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 25, 2024

Last Update Submit

March 25, 2024

Conditions

Keywords

cerebral palsyupper extremityImagination

Outcome Measures

Primary Outcomes (1)

  • Explicit motor imagery -1

    Box and block test,Participants were first asked to pass the maximum number of wooden blocks to the other side of the wooden box in 60 seconds, three times for each hand. The actual number of movement blocks was obtained by calculating the average of 3 applications. Then, each participant was asked to visually pass the maximum number of wooden blocks to the other side of the wooden box without moving, three times for both hands. While visualizing, the participants pressed the button in front of them for each wooden block they placed, thus the number of wooden blocks they imagined passing to the other side was seen. The number of imaged movement blocks was obtained by taking the average of 3 applications. The number of wooden blocks passed with actual movement and imagined movement was compared.

    two years

Secondary Outcomes (3)

  • Explicit motor imagery - 2

    two years

  • Explicit motor imagery - 3

    two years

  • Implicit motor imagery

    two years

Study Arms (3)

Unilateral cerebral palsy

Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic unilateral CP, involvement occurs unilaterally in one half of the body.

Other: Implicit motor imageryOther: Explicit motor imagery

Bilateral cerebral palsy

Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic bilateral CP, involvement is seen bilaterally in all 4 extremities.

Other: Implicit motor imageryOther: Explicit motor imagery

Typically developing children

Children with typical development are children who behave in accordance with the developmental level expected for their age.

Other: Implicit motor imageryOther: Explicit motor imagery

Interventions

Implicit motor imagery is the ability to engage with the projection and manipulation of the body schema from a first-person perspective. Implicit motor imagery skills were evaluated Recognize App Recognize Hand Hand Laterality Task with, developed by NOI group. (http://www.noigroup.com/ Recognise).

Bilateral cerebral palsyTypically developing childrenUnilateral cerebral palsy

In explicit motor imagery, the person simulates a specific motor movement, that is, the individual is aware that she is imagining the movement.Explicit motor imagery skills were evaluated with Movement Imagery Questionnaire for Children (MIQ-C), mental chronometry and box block test.

Bilateral cerebral palsyTypically developing childrenUnilateral cerebral palsy

Eligibility Criteria

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

This study included between the ages 6 and 18 years 10 children with unilateral and bilateral cerebral palsy with level 1 or 2 according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System (CFCS) and 10 typically developing children.

You may qualify if:

  • Diagnosed with spastic type CP between the ages of 6-18
  • Gross Motor Function Classification System (GMFSS) level 1- 2
  • Manual Dexterity Classification System (EBSS) level 1-2
  • Having at least 24 points from the Mini-Mental test for children,
  • Having an IQ \> 70,
  • To be able to understand the instructions of the study.

You may not qualify if:

  • Having severe vision, hearing or attention problems,
  • Having advanced cardiovascular or cognitive problems,
  • Not being able to follow work instructions,
  • Having had upper extremity surgery within the last 6 months,
  • Having received MI training in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Zonguldak, Ereğli, 67300, Turkey (Türkiye)

RECRUITING

Bolu Abant İzzet Baysal University

Bolu, Gölköy/ Bolu, 14030, Turkey (Türkiye)

RECRUITING

Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Düzce, Merkez, 81100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Seda Ayaz Taş, Phd

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda Ayaz Taş, Phd

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 3, 2024

Study Start

July 18, 2023

Primary Completion

May 5, 2024

Study Completion

June 25, 2024

Last Updated

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations