HealthyNCT04744597
Fitt's Law MI Experiment
A study testing Real execution of Fitts's law tasks, Motor imagery of Fitts's law tasks and Skip counting in people with Healthy, run by Science and Research Centre Koper.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real execution of Fitts's law tasks, Motor imagery of Fitts's law tasks and Skip counting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born in 2009
- no significant muscular, skeleton or nervous system damage
- the earlier-signed agreement to take part in the protocol.
Who cannot join
- Nervous system disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neural Aspects of Motor Learning Through Real Execution and Motor Imagery in Children
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Real execution of Fitts's law tasks, Motor imagery of Fitts's law tasks, Skip counting
- Keywords
- EEG, Motor learning, Fitt's law, Motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real execution of Fitts's law tasksBehavioural
Also called REg
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
Motor imagery of Fitts's law tasksBehavioural
Also called MIg
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.
Skip countingBehavioural
Also called SCg
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.
| Study group | Role | What they receive |
|---|---|---|
| Real execution group | Experimental | The real execution group will perform the acute intervention by the actual performance of the Fitt's law task. Receives: 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. Receives: Behavioral: Motor imagery of Fitts's law tasks |
| Control group | Active comparator | The control group will perform skip counting. Receives: Behavioral: Skip counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in movement time (seconds) needed to solve Fitts's law tasks of different difficulites
Measured: 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
Accuracy, namely, a group of trials repeatedly hitting a narrow band (precise) but off the center of the target (inaccurate)
Measured: Assessed at baseline, immediately post intervention and at 24-yhours follow-up post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion10 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a single-blind design children will be randomized into three groups: 1st - real execution, 2nd - motor imagery, 3rd - control (skip counting)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste, University of Franche-Comté
- Responsible party
- Sponsor
- Investigators
- Uroš Marušič, PhD, Principal investigator, Science and research center Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744597
- Sponsor's protocol ID
- TwinBrainFittsLaw
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25309823Thurer 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.
PubMed 28824406Wu 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.
PubMed 29093171Ghasemian 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.
PubMed 28840774Ozdenizci 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.
PubMed 28367834Sobierajewicz 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.
PubMed 27714404
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Aspects of Motor Learning Through Real Execution and Motor Imagery in Children
- ClinicalTrials.gov ID
- NCT04744597
- Acronym / sponsor ID
- TwinBrainFittsLaw
- Conditions
- Healthy
- Keywords
- EEG, Motor learning, Fitt's law, Motor imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University of Trieste, University of Franche-Comté
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In a single-blind design children will be randomized into three groups: 1st - real execution, 2nd - motor imagery, 3rd - control (skip counting)
| Arm | Type | Receives |
|---|---|---|
| Real execution group | Experimental | Behavioral: Real execution of Fitts's law tasksThe real execution group will perform the acute intervention by the actual performance of the Fitt's law task. |
| Motor imagery group | Experimental | Behavioral: Motor imagery of Fitts's law tasksThe motor imagery group will perform the acute intervention by simulating (mental process) the Fitt's law task. |
| Control group | Active comparator | Behavioral: Skip countingThe control group will perform skip counting. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born in 2009
- no significant muscular, skeleton or nervous system damage
- the earlier-signed agreement to take part in the protocol.
Key exclusion criteria (1 listed)
- Nervous system disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real execution of Fitts's law tasksAlso: REgChildren will be training Fitts's law tasks of different difficulties. Once each task will be solved, they will receive a new, more demanding task | Behavioural | Real execution group |
| Motor imagery of Fitts's law tasksAlso: MIgChildren 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. | Behavioural | Motor imagery group |
| Skip countingAlso: SCgChildren 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. | Behavioural | Control group |
Primary outcome
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
Event related potential that are typically linked with updating of internal models, decision-making and motor preparation.
2 secondary outcomes
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 25309823Kiefer 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.
- Background: PubMed 28824406Thurer 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.
- Background: PubMed 29093171Wu 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.
- Background: PubMed 28840774Ghasemian 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.
- Background: PubMed 28367834Ozdenizci 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.
- Background: PubMed 27714404Sobierajewicz 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.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uroš Marušič, PhD principal investigator
Science and research center Koper
Questions about this trial
What is this clinical trial studying?
A study testing Real execution of Fitts's law tasks, Motor imagery of Fitts's law tasks and Skip counting in people with Healthy, run by Science and Research Centre Koper.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luka Šlosar, PhD (0038640612132, luka.slosar@zrs-kp.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744597, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.