NeuroplasticityNCT05587907
Reaction Time, Cognitive Function and Physical Fitness of Children and Adolescent Soccer Players
A study testing FitLight Trainer in people with Neuroplasticity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Investigation of the effect of an exercise program with visual stimuli on reaction time, cognitive function and physical fitness of children and adolescent soccer players. Read more about this study
- Who is it for?
- Ages 10 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuroplasticity
- What is being tested?
- FitLight Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGreece
- Study dates
- 21 Apr 2021to 31 Aug 2022
- 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 10 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Inclusion Criteria: male sex, age 10-15 years, soccer experience ≥ 1year
Exclusion Criteria: None
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Sport Medicine, Department of Physical Education and Sports Sciences Aristotle University of Thessaloniki
Thessaloniki, 57001
About this study
Official title: The Effect of an Exercise Program With Visual Stimuli on Reaction Time, Cognitive Function and Physical Fitness of Children and Adolescent Soccer Players
Investigation of the effect of an exercise program with visual stimuli on reaction time, cognitive function and physical fitness of children and adolescent soccer players.
Read the detailed description
38 male soccer players aged 10-15 participate in the research voluntarily. A wireless reflex measurement system (FITLIGHT Trainer) is used to measure the response time, a cognitive function test (Cognitive Function Scanner Mobile) is used to assess cognitive function and an interactive virtual reality application (VR game) is used to estimate the visual field. Physical fitness is assessed using ALPHA-Fitness and the Eurofit test batteries. The screening takes place in the soccer field with portable devices. After the initial check, the participants were randomly divided into two equal groups using the program http://www.randomizer.org/.
18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The special training program includes training using illuminated units / disks. Each unit is activated alternately, and it is deactivated when the trainee passes in front of it or touches it with any part of his body as well as with another object / sports accessory. The remaining players continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
- Conditions
- Neuroplasticity
- Being tested
- FitLight Trainer
- Keywords
- Reaction Time, Cognitive Function, Physical Fitness, FITLIGHT Trainer, Visual Field, VR, soccer players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitLight TrainerDevice
Also called Cognitive Function Scanner Mobile, VR game, Eurofit Physical Fitness Test Battery, ALPHA-Fitness test battery
Evaluation of the reaction time before and after special training program using visual stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. Receives: Device: FitLight Trainer |
| Group 2 | No intervention | 20 soccer players follow a regular soccer training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (sec)
VR game, FITLIGHT Trainer
Measured: 6 months
Cognitive function (sec)
Cognitive Function Scanner Mobile
Measured: 6 months
Secondary outcomes (1)
Physical fitness
RFD (kg/sec), Hand grip test (kg), Sit \& reach flexibility (cm), Repeated Sprint (sec)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start21 Apr 2021
- Primary completion12 Dec 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroplasticityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Around half of the participants follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The other half of the participants will continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
- Investigators
- EVANGELIA KOUIDI, PhD, Study chair, Department of Physical Education and Sports Sciences Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587907
- Sponsor's protocol ID
- 68/2021
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Exercise Program With Visual Stimuli on Reaction Time, Cognitive Function and Physical Fitness of Children and Adolescent Soccer Players
- ClinicalTrials.gov ID
- NCT05587907
- Acronym / sponsor ID
- 68/2021
- Conditions
- Neuroplasticity
- Keywords
- Reaction Time, Cognitive Function, Physical Fitness, FITLIGHT Trainer, Visual Field, VR, soccer players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 20 Oct 2022 (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.
Investigation of the effect of an exercise program with visual stimuli on reaction time, cognitive function and physical fitness of children and adolescent soccer players.
Detailed description
38 male soccer players aged 10-15 participate in the research voluntarily. A wireless reflex measurement system (FITLIGHT Trainer) is used to measure the response time, a cognitive function test (Cognitive Function Scanner Mobile) is used to assess cognitive function and an interactive virtual reality application (VR game) is used to estimate the visual field. Physical fitness is assessed using ALPHA-Fitness and the Eurofit test batteries. The screening takes place in the soccer field with portable devices. After the initial check, the participants were randomly divided into two equal groups using the program http://www.randomizer.org/.
18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The special training program includes training using illuminated units / disks. Each unit is activated alternately, and it is deactivated when the trainee passes in front of it or touches it with any part of his body as well as with another object / sports accessory. The remaining players continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Around half of the participants follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The other half of the participants will continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: FitLight Trainer18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. |
| Group 2 | No intervention | –20 soccer players follow a regular soccer training program. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| FitLight TrainerAlso: Cognitive Function Scanner Mobile, VR game, Eurofit Physical Fitness Test Battery, ALPHA-Fitness test batteryEvaluation of the reaction time before and after special training program using visual stimuli. | Device | Group 1 |
Primary outcome
Reaction time (sec)
Time frame: 6 months
VR game, FITLIGHT Trainer
Cognitive function (sec)
Time frame: 6 months
Cognitive Function Scanner Mobile
1 secondary outcome
Physical fitness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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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.
EVANGELIA KOUIDI, PhD study chair
Department of Physical Education and Sports Sciences Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitLight Trainer in people with Neuroplasticity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (sec) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.