- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04744597
Fitt's Law MI Experiment
Neural Aspects of Motor Learning Through Real Execution and Motor Imagery in Children
Study Overview
Status
Conditions
Detailed Description
Studies show changes in alpha (7.5 - 15 Hz) and beta (15 - 30 Hz) frequencies before and during motor tasks. However, researchers still disagree on the origin, timing, and direction of this. The neurophysiological mechanisms of motor learning are not yet fully understood. The authors note that event-related beta desynchronization is most commonly associated with motor learning. Reduced beta wave power can be observed in motor cortex, but it is still unclear whether this change is related to motor learning, performance, or movement repetition.
A comparative study of motor imagery and actual performance showed the occurrence of similar neurophysiological processes in the motor cortex. All the mentioned studies were conducted on adults and the results were mainly from the analysis of upper limb movements. In the present study, the investigators will comprehensively evaluate the upper and lower limb movements of children: from the recognition of visual stimuli to the generation of the motor program and the execution itself (behavioral data).
Forty-five children (year 2009) will be recruited from local primary schools. In a single-blinded design, children will be randomized into three groups (1st - real execution, 2nd - motor imagery, 3rd - control) and compared at baseline, immediately post-intervention and at follow-up 24 hours post-intervention. At pre-, post-, and follow-up assessments, participants will perform two different patterns of the Fitts Law task with the predefined difficulty: lower limbs/whole body and upper limbs/hands on an interactive whiteboard. The intervention period lasts approximately 10 minutes, during which participants perform the Fitts law task with different difficulty according to the intervention group to which they belong.
During the upper limb/hand tasks, brain activity will be recorded with electroencephalography (EEG).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- born in 2009
- no significant muscular, skeleton or nervous system damage
- the earlier-signed agreement to take part in the protocol.
Exclusion Criteria:
- Nervous system disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real execution group
The real execution group will perform the acute intervention by the actual performance of the Fitt's law task.
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Children will be training Fitts's law tasks of different difficulties.
Once each task will be solved, they will receive a new, more demanding task
Other Names:
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Experimental: Motor imagery group
The motor imagery group will perform the acute intervention by simulating (mental process) the Fitt's law task.
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Children will be training Fitts's law tasks of different difficulties, same as RE group but the exception of doing it mentally - motor imagery of Fitts's law tasks with eyes open.
Other Names:
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Active Comparator: Control group
The control group will perform skip counting.
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Children in SCg will silently count (one number per second) in the same working blocks as both experimental groups with a task of saying the number they reached during each block - control condition to keep them mentally active at very low mental engagement.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Movement related cortical potential at 24-yhours follow-up post intervention
Time Frame: Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
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Event related potential that are typically linked with updating of internal models, decision-making and motor preparation.
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Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Fitts's law task performance at 24-yhours follow-up post intervention
Time Frame: Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
|
Change in movement time (seconds) needed to solve Fitts's law tasks of different difficulites
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Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
|
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Change from baseline Fitts's law task performance at 24-yhours follow-up post intervention
Time Frame: Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
|
Accuracy, namely, a group of trials repeatedly hitting a narrow band (precise) but off the center of the target (inaccurate)
|
Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Uroš Marušič, PhD, Science and research center Koper
Publications and helpful links
General Publications
- Kiefer AW, Gualberto Cremades J, Myer GD. Train the Brain: Novel Electroencephalography Data Indicate Links between Motor Learning and Brain Adaptations. J Nov Physiother. 2014 Apr;4(2):198. doi: 10.4172/2165-7025.1000198.
- Thurer B, Stockinger C, Putze F, Schultz T, Stein T. Mechanisms within the Parietal Cortex Correlate with the Benefits of Random Practice in Motor Adaptation. Front Hum Neurosci. 2017 Aug 2;11:403. doi: 10.3389/fnhum.2017.00403. eCollection 2017.
- Wu J, Knapp F, Cramer SC, Srinivasan R. Electroencephalographic connectivity measures predict learning of a motor sequencing task. J Neurophysiol. 2018 Feb 1;119(2):490-498. doi: 10.1152/jn.00580.2017. Epub 2017 Nov 1.
- Ghasemian M, Taheri H, Saberi Kakhki A, Ghoshuni M. Electroencephalography Pattern Variations During Motor Skill Acquisition. Percept Mot Skills. 2017 Dec;124(6):1069-1084. doi: 10.1177/0031512517727404. Epub 2017 Aug 25.
- Ozdenizci O, Yalcin M, Erdogan A, Patoglu V, Grosse-Wentrup M, Cetin M. Electroencephalographic identifiers of motor adaptation learning. J Neural Eng. 2017 Aug;14(4):046027. doi: 10.1088/1741-2552/aa6abd.
- Sobierajewicz J, Przekoracka-Krawczyk A, Jaskowski W, Verwey WB, van der Lubbe R. The influence of motor imagery on the learning of a fine hand motor skill. Exp Brain Res. 2017 Jan;235(1):305-320. doi: 10.1007/s00221-016-4794-2. Epub 2016 Oct 6.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TwinBrainFittsLaw
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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