NCT04744597

Brief Summary

The aim of our study is to investigate the acute effects of real execution (RE) and motor imagery (MI) of Fitts law tasks on near and far transfer of learning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

January 25, 2021

Last Update Submit

February 4, 2021

Conditions

Keywords

EEGMotor learningFitt's lawMotor imagery

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Movement related cortical potential at 24-yhours follow-up post intervention

    Event related potential that are typically linked with updating of internal models, decision-making and motor preparation.

    Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention

Secondary Outcomes (2)

  • Change from baseline Fitts's law task performance at 24-yhours follow-up post intervention

    Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention

  • Change from baseline Fitts's law task performance at 24-yhours follow-up post intervention

    Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention

Study Arms (3)

Real execution group

EXPERIMENTAL

The real execution group will perform the acute intervention by the actual performance of the Fitt's law task.

Behavioral: Real execution of Fitts's law tasks

Motor imagery group

EXPERIMENTAL

The motor imagery group will perform the acute intervention by simulating (mental process) the Fitt's law task.

Behavioral: Motor imagery of Fitts's law tasks

Control group

ACTIVE COMPARATOR

The control group will perform skip counting.

Behavioral: Skip counting

Interventions

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

Also known as: REg
Real execution group

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.

Also known as: MIg
Motor imagery group
Skip countingBEHAVIORAL

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.

Also known as: SCg
Control group

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • born in 2009
  • no significant muscular, skeleton or nervous system damage
  • the earlier-signed agreement to take part in the protocol.

You may not qualify if:

  • Nervous system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 25309823BACKGROUND
  • 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.

    PMID: 28824406BACKGROUND
  • 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.

    PMID: 29093171BACKGROUND
  • 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.

    PMID: 28840774BACKGROUND
  • 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.

    PMID: 28367834BACKGROUND
  • 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.

    PMID: 27714404BACKGROUND

Study Officials

  • Uroš Marušič, PhD

    Science and research center Koper

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luka Šlosar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: In a single-blind design children will be randomized into three groups: 1st - real execution, 2nd - motor imagery, 3rd - control (skip counting)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 9, 2021

Study Start

February 1, 2021

Primary Completion

May 10, 2021

Study Completion

June 1, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02