Cerebral PalsyNCT06295419
The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy
A study testing dual task and single task in people with Cerebral Palsy, run by Igdir University.
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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- dual task and single task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be between the ages of 7-15,
- Not having a chronic disease.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy With Healthy Controls
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Cerebral Palsy
- Being tested
- dual task, single task
- Keywords
- cerebral Palsy, dual-task, manual ability, trunk control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual taskOther
cerebral palsy and healthy controls will be evaluated dual task conditions
single taskOther
cerebral palsy and healthy controls will be evaluated single task conditions
| Study group | Role | What they receive |
|---|---|---|
| cerebral palsy | Experimental | cerebral palsy will be evaluated single and dual task conditions Receives: Other: dual task; Other: single task |
| healthy controls | Experimental | Healthy controls will be evaluated single and dual task conditions Receives: Other: dual task; Other: single task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1minute
motor performance of manual skills (writing a paragraph) (single task)
the time will be recorded by asking to write a given paragraph.
Measured: 2minutes
motor performance of manual skills (single task)
the 9-Hole Peg Test will be applied and the time will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Bugusan Oruc, Igdir University
- Investigators
- Sema Büğüşan Oruç, PhD, Principal investigator, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295419
- Sponsor's protocol ID
- Igdir182
- Status last verified
- May 2024
- First submitted
- 28 Feb 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18452729Gathercole 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.
PubMed 14979759Pena 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.
PubMed 30621370Wollesen 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.
PubMed 35091209Rubsam 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.
PubMed 37941469
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy With Healthy Controls
- ClinicalTrials.gov ID
- NCT06295419
- Acronym / sponsor ID
- Igdir182
- Conditions
- Cerebral Palsy
- Keywords
- cerebral Palsy, dual-task, manual ability, trunk control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy | Experimental | Other: dual task, Other: single taskcerebral palsy will be evaluated single and dual task conditions |
| healthy controls | Experimental | Other: dual task, Other: single taskHealthy controls will be evaluated single and dual task conditions |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants must be between the ages of 7-15,
- Not having a chronic disease.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual taskcerebral palsy and healthy controls will be evaluated dual task conditions | Other | cerebral palsy, healthy controls |
| single taskcerebral palsy and healthy controls will be evaluated single task conditions | Other | cerebral palsy, healthy controls |
Primary outcome
Abilhand Kids
Time frame: 5minutes
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.
cognitive task (single task)
Time frame: 1minute
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.
motor performance of manual skills (writing a paragraph) (single task)
Time frame: 2minutes
the time will be recorded by asking to write a given paragraph.
motor performance of manual skills (single task)
Time frame: 2minutes
the 9-Hole Peg Test will be applied and the time will be recorded.
motor performance of manual skills (dual task)
Time frame: 2minutes
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.
motor performance of manual skills (writing a paragraph) (dual task)
Time frame: 2minutes
Dual task evaluations will be administered by giving a simultaneous cognitive task while writing a paragraph. And the time will be recorded.
The Body Control Measurement Scale
Time frame: 10minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 18452729Reilly 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.
- Background: PubMed 14979759Gathercole 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.
- Background: PubMed 30621370Pena 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.
- Background: PubMed 35091209Wollesen 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.
- Background: PubMed 37941469Rubsam 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.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sema Büğüşan Oruç, PhD principal investigator
Igdir University
Questions about this trial
What is this clinical trial studying?
A study testing dual task and single task in people with Cerebral Palsy, run by Igdir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sema Büğüşan Oruç, PhD (+90(476)2230010, semabugusan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abilhand Kids (time frame: 5minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295419, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.