NCT06295419

Brief Summary

The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers. Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:

  • Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.
  • Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.
  • Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
  • In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
  • Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.
  • In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.
  • The Body Control Measurement Scale will be applied for body evaluation purposes. As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

February 28, 2024

Last Update Submit

May 17, 2024

Conditions

Keywords

cerebral Palsydual-taskmanual abilitytrunk control

Outcome Measures

Primary Outcomes (7)

  • Abilhand Kids

    Abilhand Kids is a questionnaire that evaluates children's upper extremities bimanually, has proven validity and reliability, and includes 21 questions for families about the common tasks their children undertake in daily life activities.

    5minutes

  • cognitive task (single task)

    The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.

    1minute

  • motor performance of manual skills (writing a paragraph) (single task)

    the time will be recorded by asking to write a given paragraph.

    2minutes

  • motor performance of manual skills (single task)

    the 9-Hole Peg Test will be applied and the time will be recorded.

    2minutes

  • motor performance of manual skills (dual task)

    Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Peg Test. And the time will be recorded.

    2minutes

  • motor performance of manual skills (writing a paragraph) (dual task)

    Dual task evaluations will be administered by giving a simultaneous cognitive task while writing a paragraph. And the time will be recorded.

    2minutes

  • The Body Control Measurement Scale

    The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on an ordinal scale of 2, 3, and 4 points. Although the total score of the scale varies between 0-58 points, higher scores indicate better performance.

    10minutes

Study Arms (2)

cerebral palsy

EXPERIMENTAL

cerebral palsy will be evaluated single and dual task conditions

Other: dual taskOther: single task

healthy controls

EXPERIMENTAL

Healthy controls will be evaluated single and dual task conditions

Other: dual taskOther: single task

Interventions

cerebral palsy and healthy controls will be evaluated dual task conditions

cerebral palsyhealthy controls

cerebral palsy and healthy controls will be evaluated single task conditions

cerebral palsyhealthy controls

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants must be between the ages of 7-15,
  • Not having a chronic disease.

You may not qualify if:

  • Participants must have had Botulinum Toxin applied to the upper extremity in the last 6 months
  • Participants must have had a health problem or had an operation that would affect the musculoskeletal system or dexterity performance in the last year (EX: Distal radius fracture).
  • Having concentration problems such as attention deficit hyperactivity disorder (ADHD).
  • Not volunteering to participate in the study and not signing a consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Reilly DS, Woollacott MH, van Donkelaar P, Saavedra S. The interaction between executive attention and postural control in dual-task conditions: children with cerebral palsy. Arch Phys Med Rehabil. 2008 May;89(5):834-42. doi: 10.1016/j.apmr.2007.10.023.

    PMID: 18452729BACKGROUND
  • Gathercole SE, Pickering SJ, Ambridge B, Wearing H. The structure of working memory from 4 to 15 years of age. Dev Psychol. 2004 Mar;40(2):177-90. doi: 10.1037/0012-1649.40.2.177.

    PMID: 14979759BACKGROUND
  • Pena GM, Pavao SL, Oliveira MF, de Campos AC, Rocha NA. Dual-task effects in children with neuromotor dysfunction: a systematic review. Eur J Phys Rehabil Med. 2019 Apr;55(2):281-290. doi: 10.23736/S1973-9087.19.05556-4. Epub 2019 Jan 8.

    PMID: 30621370BACKGROUND
  • Wollesen B, Janssen TI, Muller H, Voelcker-Rehage C. Effects of cognitive-motor dual task training on cognitive and physical performance in healthy children and adolescents: A scoping review. Acta Psychol (Amst). 2022 Apr;224:103498. doi: 10.1016/j.actpsy.2022.103498. Epub 2022 Jan 25.

    PMID: 35091209BACKGROUND
  • Rubsam M, Girolami GL, Bhatt T. Heterogeneity of Tasks and Outcome Measures in Dual Tasking Studies in Children With Cerebral Palsy: A Scoping Review. Phys Ther. 2024 Jan 1;104(1):pzad151. doi: 10.1093/ptj/pzad151.

    PMID: 37941469BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sema Büğüşan Oruç, PhD

    Igdir University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sema Büğüşan Oruç, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

October 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share