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Effects of Acute Exercise on Motor Learning and Brain Activity in Children With DCD (ExLeBrainDCD)

Primary Purpose

Developmental Coordination Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Acute intense aerobic exercise
Sponsored by
Institut Nacional d'Educacio Fisica de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder focused on measuring Visuomotor adaptation, Attention, Physical exercise, Functional near-infrared spectroscopy (fNIRS), Cortical activation, Prefrontal cortex, Children

Eligibility Criteria

90 Months - 126 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Movement assessment battery for children - second edition (MABC-2) score: developmental coordination disorder (DCD) group score <15% and typically developed (TD) group score >25% An average or better cognitive ability tested through the Test of Nonverbal Intelligence version 4 (TONI-4) A parent-report history to confirm that, according to the child's pediatrician, motor difficulties showed by their child cannot be explained by any other neurological, developmental, and/or severe psychosocial problem. Comorbid attention deficit hyperactivity disorder, attention deficit disorder, and dyslexia will be acceptable in order to better represent the DCD population since data population-based studies suggest that almost 40% of the children with DCD have combined problems related to learning and/or attentional disorders. Exclusion Criteria: Participant health status do not allow hem/her to participate in physical activities (Physical Activity Readiness Questionnaire, PAR-Q) Other comorbidities than attention deficit hyperactivity disorder, attention deficit disorder, and/or dyslexia Reported neurological, developmental, and/or severe psychosocial problem that could explain the motor development problem Participant that takes medication that could affect results Uncorrected 20/20 vision

Sites / Locations

  • Escola Bosc de MontjuïcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

EX-TD

CON-TD

EX-DCD

CON-DCD

Arm Description

Typical developed children that perform acute exercise prior to the learning task

Typical developed children that not perform acute exercise prior to the learning task

Children with developmental coordination disorder (DCD) that perform acute exercise prior to the learning task

Children with developmental coordination disorder (DCD) that not perform acute exercise prior to the learning task

Outcomes

Primary Outcome Measures

initial directional error
Initial directional error (IDE) will be calculated as the absolute angular difference between the ideal trajectory, a linear vector from the center to the target, and the early real trajectory, defined by the linear vector from the center to the cursor position at the time of 80 ms after movement onset.
root mean square error
Root mean square error (RMSE) will be calculated to represent the straightness of the movement between the ideal trajectory and the real joystick trajectory.
initial rate of learning
The initial rate of learning (RL) will be computed as the first derivative of the first half of the function and evaluated at epoch 1 for both error variables initial directional error (RL-IDE) and root mean square error (RL-RMSE).
relative oxyhemoglobin concentration ([02Hb]) in the ventrolateral prefrontal cortex
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
relative oxyhemoglobin concentration ([02Hb]) in the dorsolateral prefrontal cortex
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
relative deoxyhemoglobin concentration ([HHb]) in the ventrolateral prefrontal cortex
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
relative deoxyhemoglobin concentration ([HHb]) in the dorsolateral prefrontal cortex
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).

Secondary Outcome Measures

movement time
Time spend moving the cursor from its initial position to its final position
travel distance
Displacement of the cursor from its initial position to its final position
reaction time
Reaction time will be defined as the time between target appearance and movement onset.

Full Information

First Posted
June 9, 2023
Last Updated
June 30, 2023
Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
Collaborators
ICFO - The Institute of Photonic Sciences, Ministerio de Ciencia e Innovación, Spain, University of Stuttgart, The University of Texas at Arlington
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1. Study Identification

Unique Protocol Identification Number
NCT05936372
Brief Title
Effects of Acute Exercise on Motor Learning and Brain Activity in Children With DCD
Acronym
ExLeBrainDCD
Official Title
Study Protocol to Examine the Effects of Acute Exercise on Motor Learning and Brain Activity in Children With Developmental Coordination Disorder (ExLe-Brain-DCD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
Collaborators
ICFO - The Institute of Photonic Sciences, Ministerio de Ciencia e Innovación, Spain, University of Stuttgart, The University of Texas at Arlington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the impact of an acute intense physical exercise bout on the learning ability of children with typical motor development (TD) and children with developmental coordination disorder (DCD). The effects will be studied during the learning and in the short- (1 hour), medium- (24 hours), and long-terms (7 days) after the initial learning. Participants will be divided into 4 groups: children with typical development who will exercise (EX-TD), children with developmental coordination disorder who will exercise (EX-DCD), children with typical development who will not exercise (CON-TD), and children with developmental coordination disorder who will not exercise (CON-DCD). Participants will be enrolled for 4 different sessions: Session 1: First, participants will do a test to asses their cognitive ability and their height and weight will be measured. Then, participants will run a race test to assess their level of physical condition and to calculate high and moderate intensities of the exercise bout. The test will consist of running from one side to the other of a 20 m long track, while following the rhythm set by a sound. Session 2: at least 48 hours after the first one, the participants will do an exercise bout running from side to side of a 20 m long track alternating high and moderate intensities during 13 min. The members of the control groups (CON-TD and CON-DCD) will not perform this exercise and, instead, will remain at rest for a time equivalent to the exercise of the other groups. On the other hand, participants will perform a learning task involving hand-eye coordination, in which participants will control the movements of a circle on a computer screen using a joystick. The objective of this task will be to move the circle to target points that will appear on the screen with the maximum accuracy and speed possible. Participants will be asked to practice this task for approximately 8 min. Then, after a 1-hour rest period, the participants will be asked to perform the learning task again (only 3.5 min) to check the level of retention of the initial learning. A headcap will be adjusted on the head of the participants during the motor task performance to measure the activity of the brain through infrared light. Sessions 3 and 4: participants will complete two retention tests of the learning task (one in each session) 24 hours and 7 days after the second session, respectively. Participants will also wear the headcap for the brain activity measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
Keywords
Visuomotor adaptation, Attention, Physical exercise, Functional near-infrared spectroscopy (fNIRS), Cortical activation, Prefrontal cortex, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EX-TD
Arm Type
Experimental
Arm Description
Typical developed children that perform acute exercise prior to the learning task
Arm Title
CON-TD
Arm Type
No Intervention
Arm Description
Typical developed children that not perform acute exercise prior to the learning task
Arm Title
EX-DCD
Arm Type
Experimental
Arm Description
Children with developmental coordination disorder (DCD) that perform acute exercise prior to the learning task
Arm Title
CON-DCD
Arm Type
No Intervention
Arm Description
Children with developmental coordination disorder (DCD) that not perform acute exercise prior to the learning task
Intervention Type
Behavioral
Intervention Name(s)
Acute intense aerobic exercise
Intervention Description
The acute intense aerobic exercise bout (iE) will consist of a 13-minute 20-meter shuttle run. During this exercise bout two speeds, based on a percentage of the estimated maximal oxygen consumption (VO2max), will be combined: a fast-paced speed (fast: 85% of VO2max) and a slow-paced speed (slow: 60% VO2max). A total of 3 series of 3 min of the fast-paced speed will be carried interspersed with 2 series of 2 min of the slow-paced speed. Prior to the iE start, a warm-up protocol consisting of 2 min slow and 1 min fast will be done with the objective to familiarize participants with the iE speeds. A 5-minute rest period will be guaranteed before starting the iE. Transition time between iE and the rotational visuomotor adaptation task (rVMA) will be 4 min.
Primary Outcome Measure Information:
Title
initial directional error
Description
Initial directional error (IDE) will be calculated as the absolute angular difference between the ideal trajectory, a linear vector from the center to the target, and the early real trajectory, defined by the linear vector from the center to the cursor position at the time of 80 ms after movement onset.
Time Frame
0, 1, and 24 hours, and 7 days
Title
root mean square error
Description
Root mean square error (RMSE) will be calculated to represent the straightness of the movement between the ideal trajectory and the real joystick trajectory.
Time Frame
0, 1, and 24 hours, and 7 days
Title
initial rate of learning
Description
The initial rate of learning (RL) will be computed as the first derivative of the first half of the function and evaluated at epoch 1 for both error variables initial directional error (RL-IDE) and root mean square error (RL-RMSE).
Time Frame
0, 1, and 24 hours, and 7 days
Title
relative oxyhemoglobin concentration ([02Hb]) in the ventrolateral prefrontal cortex
Description
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
0, 1, and 24 hours, and 7 days
Title
relative oxyhemoglobin concentration ([02Hb]) in the dorsolateral prefrontal cortex
Description
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
0, 1, and 24 hours, and 7 days
Title
relative deoxyhemoglobin concentration ([HHb]) in the ventrolateral prefrontal cortex
Description
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
0, 1, and 24 hours, and 7 days
Title
relative deoxyhemoglobin concentration ([HHb]) in the dorsolateral prefrontal cortex
Description
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
0, 1, and 24 hours, and 7 days
Secondary Outcome Measure Information:
Title
movement time
Description
Time spend moving the cursor from its initial position to its final position
Time Frame
0, 1, and 24 hours, and 7 days
Title
travel distance
Description
Displacement of the cursor from its initial position to its final position
Time Frame
0, 1, and 24 hours, and 7 days
Title
reaction time
Description
Reaction time will be defined as the time between target appearance and movement onset.
Time Frame
0, 1, and 24 hours, and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
90 Months
Maximum Age & Unit of Time
126 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Movement assessment battery for children - second edition (MABC-2) score: developmental coordination disorder (DCD) group score <15% and typically developed (TD) group score >25% An average or better cognitive ability tested through the Test of Nonverbal Intelligence version 4 (TONI-4) A parent-report history to confirm that, according to the child's pediatrician, motor difficulties showed by their child cannot be explained by any other neurological, developmental, and/or severe psychosocial problem. Comorbid attention deficit hyperactivity disorder, attention deficit disorder, and dyslexia will be acceptable in order to better represent the DCD population since data population-based studies suggest that almost 40% of the children with DCD have combined problems related to learning and/or attentional disorders. Exclusion Criteria: Participant health status do not allow hem/her to participate in physical activities (Physical Activity Readiness Questionnaire, PAR-Q) Other comorbidities than attention deficit hyperactivity disorder, attention deficit disorder, and/or dyslexia Reported neurological, developmental, and/or severe psychosocial problem that could explain the motor development problem Participant that takes medication that could affect results Uncorrected 20/20 vision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Busquets Faciaben, PhD
Phone
+34934255445
Ext
213
Email
albert.busquets@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Blai Ferrer Uris, PhD
Phone
+34934255445
Ext
213
Email
bferrer@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Busquets Faciaben, PhD
Organizational Affiliation
Institut Nacional d'Educació Física de Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa M Angulo Barroso, PhD
Organizational Affiliation
Institut Nacional d'Educació Física de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Bosc de Montjuïc
City
Barcelona
ZIP/Postal Code
08038
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta
Phone
934414224
Email
a8003491@xtec.cat

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only after finishing the study and with the express authorization of the Department of Education of the Generalitat of Catalonia, the data processed and anonymized will be stored in a specialized repository for research purposes. The data in this repository will be placed under the Creative Commons Attribution-Non Comercial-Share Alike (CC BY-NC-SA) license. They will only be used for scientific purposes and after requesting permission from the authors and under the same conditions that we have established. The following data will not be made publicly available: Personal data and other data that can be tracked to participants identity. Data that compromises the protection of a partner(s) intellectual property. The level of data made available will also be considered, for example, pre-processed data will not be provided unless there is a clear reason for doing so. Datasets which cannot be shared because of legal and contractual reasons.
IPD Sharing Time Frame
After finishing the study
IPD Sharing Access Criteria
Once processing, quality control, organisation, analysis, and publication are complete, the data will be made accessible by deposition in open access repositories (https://b2share.eudat.eu). Members of the research team will form a data access committee. This committee will oversee that openly accessible data respect ethical and data security aspects, including intellectual property requirements. The possibilities of accessing the data in the specialized repository will always be decided in consultation with our collaborators and the Department of Education of the Generalitat de Catalunya.
Citations:
PubMed Identifier
34482014
Citation
Smits-Engelsman B, Verbecque E. Pediatric care for children with developmental coordination disorder, can we do better? Biomed J. 2022 Apr;45(2):250-264. doi: 10.1016/j.bj.2021.08.008. Epub 2021 Sep 2.
Results Reference
background
PubMed Identifier
25193246
Citation
Adams IL, Lust JM, Wilson PH, Steenbergen B. Compromised motor control in children with DCD: a deficit in the internal model?-A systematic review. Neurosci Biobehav Rev. 2014 Nov;47:225-44. doi: 10.1016/j.neubiorev.2014.08.011. Epub 2014 Sep 1.
Results Reference
background
PubMed Identifier
10933211
Citation
Fuster JM. Executive frontal functions. Exp Brain Res. 2000 Jul;133(1):66-70. doi: 10.1007/s002210000401.
Results Reference
background
PubMed Identifier
31590737
Citation
Fuster JM. The prefrontal cortex in the neurology clinic. Handb Clin Neurol. 2019;163:3-15. doi: 10.1016/B978-0-12-804281-6.00001-X.
Results Reference
background
PubMed Identifier
22191933
Citation
Goto K, Hoshi Y, Sata M, Kawahara M, Takahashi M, Murohashi H. Role of the prefrontal cortex in the cognitive control of reaching movements: near-infrared spectroscopy study. J Biomed Opt. 2011 Dec;16(12):127003. doi: 10.1117/1.3658757.
Results Reference
background
PubMed Identifier
9084599
Citation
Jueptner M, Stephan KM, Frith CD, Brooks DJ, Frackowiak RS, Passingham RE. Anatomy of motor learning. I. Frontal cortex and attention to action. J Neurophysiol. 1997 Mar;77(3):1313-24. doi: 10.1152/jn.1997.77.3.1313.
Results Reference
background
PubMed Identifier
36114001
Citation
Kumar N, Sidarta A, Smith C, Ostry DJ. Ventrolateral Prefrontal Cortex Contributes to Human Motor Learning. eNeuro. 2022 Sep 29;9(5):ENEURO.0269-22.2022. doi: 10.1523/ENEURO.0269-22.2022. Print 2022 Sep-Oct.
Results Reference
background
PubMed Identifier
17553994
Citation
Hampshire A, Duncan J, Owen AM. Selective tuning of the blood oxygenation level-dependent response during simple target detection dissociates human frontoparietal subregions. J Neurosci. 2007 Jun 6;27(23):6219-23. doi: 10.1523/JNEUROSCI.0851-07.2007.
Results Reference
background
PubMed Identifier
10933215
Citation
Passingham RE, Toni I, Rushworth MF. Specialisation within the prefrontal cortex: the ventral prefrontal cortex and associative learning. Exp Brain Res. 2000 Jul;133(1):103-13. doi: 10.1007/s002210000405.
Results Reference
background
PubMed Identifier
12867532
Citation
Bunge SA, Kahn I, Wallis JD, Miller EK, Wagner AD. Neural circuits subserving the retrieval and maintenance of abstract rules. J Neurophysiol. 2003 Nov;90(5):3419-28. doi: 10.1152/jn.00910.2002. Epub 2003 Jul 16.
Results Reference
background
PubMed Identifier
22171930
Citation
Blank R, Smits-Engelsman B, Polatajko H, Wilson P; European Academy for Childhood Disability. European Academy for Childhood Disability (EACD): recommendations on the definition, diagnosis and intervention of developmental coordination disorder (long version). Dev Med Child Neurol. 2012 Jan;54(1):54-93. doi: 10.1111/j.1469-8749.2011.04171.x. No abstract available.
Results Reference
background
PubMed Identifier
29523049
Citation
Ferrer-Uris B, Busquets A, Angulo-Barroso R. Adaptation and Retention of a Perceptual-Motor Task in Children: Effects of a Single Bout of Intense Endurance Exercise. J Sport Exerc Psychol. 2018 Feb 1;40(1):1-9. doi: 10.1123/jsep.2017-0044. Epub 2018 Mar 9.
Results Reference
background
PubMed Identifier
31555181
Citation
Angulo-Barroso R, Ferrer-Uris B, Busquets A. Enhancing Children's Motor Memory Retention Through Acute Intense Exercise: Effects of Different Exercise Durations. Front Psychol. 2019 Aug 28;10:2000. doi: 10.3389/fpsyg.2019.02000. eCollection 2019.
Results Reference
background
PubMed Identifier
15585900
Citation
Kagerer FA, Bo J, Contreras-Vidal JL, Clark JE. Visuomotor adaptation in children with developmental coordination disorder. Motor Control. 2004 Oct;8(4):450-60. doi: 10.1123/mcj.8.4.450.
Results Reference
background
PubMed Identifier
17011655
Citation
Kagerer FA, Contreras-Vidal JL, Bo J, Clark JE. Abrupt, but not gradual visuomotor distortion facilitates adaptation in children with developmental coordination disorder. Hum Mov Sci. 2006 Oct;25(4-5):622-33. doi: 10.1016/j.humov.2006.06.003. Epub 2006 Oct 2.
Results Reference
background
PubMed Identifier
21584627
Citation
King BR, Kagerer FA, Harring JR, Contreras-Vidal JL, Clark JE. Multisensory adaptation of spatial-to-motor transformations in children with developmental coordination disorder. Exp Brain Res. 2011 Jul;212(2):257-65. doi: 10.1007/s00221-011-2722-z. Epub 2011 May 17.
Results Reference
background
PubMed Identifier
28473761
Citation
Lundbye-Jensen J, Skriver K, Nielsen JB, Roig M. Acute Exercise Improves Motor Memory Consolidation in Preadolescent Children. Front Hum Neurosci. 2017 Apr 20;11:182. doi: 10.3389/fnhum.2017.00182. eCollection 2017.
Results Reference
background
PubMed Identifier
27481937
Citation
Preston N, Magallon S, Hill LJ, Andrews E, Ahern SM, Mon-Williams M. A systematic review of high quality randomized controlled trials investigating motor skill programmes for children with developmental coordination disorder. Clin Rehabil. 2017 Jul;31(7):857-870. doi: 10.1177/0269215516661014. Epub 2016 Aug 1.
Results Reference
background
PubMed Identifier
14624830
Citation
Smits-Engelsman BC, Wilson PH, Westenberg Y, Duysens J. Fine motor deficiencies in children with developmental coordination disorder and learning disabilities: an underlying open-loop control deficit. Hum Mov Sci. 2003 Nov;22(4-5):495-513. doi: 10.1016/j.humov.2003.09.006.
Results Reference
background
PubMed Identifier
18709366
Citation
Wilmut K, Wann J. The use of predictive information is impaired in the actions of children and young adults with Developmental Coordination Disorder. Exp Brain Res. 2008 Dec;191(4):403-18. doi: 10.1007/s00221-008-1532-4. Epub 2008 Aug 16.
Results Reference
background
PubMed Identifier
14624831
Citation
Wilson PH, Maruff P, Lum J. Procedural learning in children with developmental coordination disorder. Hum Mov Sci. 2003 Nov;22(4-5):515-26. doi: 10.1016/j.humov.2003.09.007.
Results Reference
background
PubMed Identifier
23106668
Citation
Wilson PH, Ruddock S, Smits-Engelsman B, Polatajko H, Blank R. Understanding performance deficits in developmental coordination disorder: a meta-analysis of recent research. Dev Med Child Neurol. 2013 Mar;55(3):217-28. doi: 10.1111/j.1469-8749.2012.04436.x. Epub 2012 Oct 29.
Results Reference
background
PubMed Identifier
22705270
Citation
Zwicker JG, Missiuna C, Harris SR, Boyd LA. Developmental coordination disorder: a review and update. Eur J Paediatr Neurol. 2012 Nov;16(6):573-81. doi: 10.1016/j.ejpn.2012.05.005. Epub 2012 Jun 15.
Results Reference
background

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Effects of Acute Exercise on Motor Learning and Brain Activity in Children With DCD

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