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Clinical Trials/NCT05936372
NCT05936372
Recruiting
N/A

Study Protocol to Examine the Effects of Acute Exercise on Motor Learning and Brain Activity in Children With Developmental Coordination Disorder (ExLe-Brain-DCD)

Institut Nacional d'Educacio Fisica de Catalunya3 sites in 1 country120 target enrollmentFebruary 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Developmental Coordination Disorder
Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
Enrollment
120
Locations
3
Primary Endpoint
initial directional error
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
June 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
Responsible Party
Principal Investigator
Principal Investigator

Albert Busquets Faciaben

Principal Investigator

Institut Nacional d'Educacio Fisica de Catalunya

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

Outcomes

Primary Outcomes

initial directional error

Time Frame: 0, 1, and 24 hours, and 7 days

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

Time Frame: 0, 1, and 24 hours, and 7 days

Root mean square error (RMSE) will be calculated to represent the straightness of the movement between the ideal trajectory and the real joystick trajectory.

relative deoxyhemoglobin concentration ([HHb]) in the ventrolateral prefrontal cortex

Time Frame: 0, 1, and 24 hours, and 7 days

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

Time Frame: 0, 1, and 24 hours, and 7 days

Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration (\[HHb\]) measured by functional near-infrared spectroscopy (fNIRS).

initial rate of learning

Time Frame: 0, 1, and 24 hours, and 7 days

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

Time Frame: 0, 1, and 24 hours, and 7 days

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

Time Frame: 0, 1, and 24 hours, and 7 days

Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration (\[02Hb\]) measured by functional near-infrared spectroscopy (fNIRS).

Secondary Outcomes

  • travel distance(0, 1, and 24 hours, and 7 days)
  • reaction time(0, 1, and 24 hours, and 7 days)
  • movement time(0, 1, and 24 hours, and 7 days)

Study Sites (3)

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