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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06295419
Other study ID # Igdir182
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date August 1, 2024

Study information

Verified date March 2024
Source Igdir University
Contact Sema Bügüsan Oruç, PhD
Phone +90(476)2230010
Email semabugusan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In the literature, balance or walking postural tasks are mostly used in dual-task studies for children and young people with Cerebral Palsy (CP). However, dual task tasks performed during manual skills in daily life have not been adequately researched. 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. Although studies on this subject in the world are limited. MATERIAL AND METHOD: 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. 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. - 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. 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. The Turkish validity and reliability of the survey was conducted. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria: - Participants must be between the ages of 7-15, - Not having a chronic disease. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
dual task
cerebral palsy and healthy controls will be evaluated dual task conditions
single task
cerebral palsy and healthy controls will be evaluated single task conditions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Igdir University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary motor performance of manual skills (writing a paragraph) (single task) the time will be recorded by asking to write a given paragraph. 2minutes
Primary motor performance of manual skills (single task) the 9-Hole Peg Test will be applied and the time will be recorded. 2minutes
Primary 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
Primary 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
Primary 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
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