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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05936372
Other study ID # PID2020-120453RB-I00
Secondary ID PID2020-120453RB
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date June 2025

Study information

Verified date February 2024
Source Institut Nacional d'Educacio Fisica de Catalunya
Contact Albert Busquets Faciaben, PhD
Phone +34934255445
Email albert.busquets@gencat.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 90 Months to 126 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acute intense aerobic exercise
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.

Locations

Country Name City State
Spain Escola Bosc de Montjuïc Barcelona
Spain Escola Ramon Casas Barcelona
Spain Escola Seat Barcelona

Sponsors (5)

Lead Sponsor Collaborator
Institut Nacional d'Educacio Fisica de Catalunya ICFO - The Institute of Photonic Sciences, Ministerio de Ciencia e Innovación, Spain, The University of Texas at Arlington, University of Stuttgart

Country where clinical trial is conducted

Spain, 

References & Publications (23)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Fuster JM. Executive frontal functions. Exp Brain Res. 2000 Jul;133(1):66-70. doi: 10.1007/s002210000401. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0, 1, and 24 hours, and 7 days
Primary 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. 0, 1, and 24 hours, and 7 days
Primary 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). 0, 1, and 24 hours, and 7 days
Primary 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). 0, 1, and 24 hours, and 7 days
Primary 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). 0, 1, and 24 hours, and 7 days
Primary 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). 0, 1, and 24 hours, and 7 days
Primary 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). 0, 1, and 24 hours, and 7 days
Secondary movement time Time spend moving the cursor from its initial position to its final position 0, 1, and 24 hours, and 7 days
Secondary travel distance Displacement of the cursor from its initial position to its final position 0, 1, and 24 hours, and 7 days
Secondary reaction time Reaction time will be defined as the time between target appearance and movement onset. 0, 1, and 24 hours, and 7 days
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