Athletic InjuriesNCT06748417
FITLIGHT Reliability and Acute Training Effects
A study testing Acute Cognitive Training and Non-stimulating Rest in people with Athletic Injuries, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Acute Cognitive Training and Non-stimulating Rest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 5 Sep 2025
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a Physical Activity Readiness Questionnaire
- BMI under 30
Who cannot join
- Color-blindness
- Fractures within the past year
- Musculoskeletal injury limiting sports activity within the past 6 months
- Anterior cruciate ligament (ACL) injuries within the past 5 years
- Medical conditions that do not have physician clearance to participate in exercise
- History of concussion
Show all 11Show fewer
- Diagnosed cognitive impairments
- Untreated attention deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)
- Prisoners
- Pregnant women
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of the FITLIGHT System and Acute Effects of Cognitive Training on Dual-task Performance in Hopping and Cutting Assessments
The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.
- Conditions
- Athletic Injuries
- Being tested
- Acute Cognitive Training, Non-stimulating Rest
- Keywords
- Reaction time, neurocognitive performance, Agility training
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Cognitive TrainingDevice
Also called FITLIGHT
Participants will receive the intervention in person once within in the study for 30 minutes. During the intervention, participants will receive a cognitive training session consisting of an upper extremity, lower extremity, and whole-body reaction time task. The device (5 LED) will be placed in front of participants in all tasks, and participants will be asked to deactivate lights that illuminate for a period of 30 seconds with 30 seconds of rest. For the upper and lower extremity tasks, these will be repeated on both limbs. The purpose of the tasks are to pre-train reaction time in an isolated fashion, requiring participants to use either hands or feet to deactivate the lights, as well as incorporate whole-body movement in the third task along with a decision-making (color-matching) component.
Non-stimulating RestOther
Participants will receive the intervention in person once within the study for 30 minutes. During the intervention, participants will watch, while seated, a 30-minute segment of a nature documentary. The purpose of this intervention is to ensure no additional cognitive or movement training that would improve performance on the dual-task test occurs during the intended rest period.
| Study group | Role | What they receive |
|---|---|---|
| Acute Cognitive Training Followed by Non-stimulating Rest Group | Experimental | Participants will be in this group for approximately 11-14 days Receives: Device: Acute Cognitive Training; Other: Non-stimulating Rest |
| Non-stimulating rest followed by acute cognitive training Group | Experimental | Participants will be in this group for approximately 11-14 days Receives: Device: Acute Cognitive Training; Other: Non-stimulating Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reaction Time
Will be measured in seconds (s)
Measured: Up to 5 minutes before and up to 5 minutes after intervention
Change in Percentage of Correct Responses in Cognitive-Motor Running T-test
Percentage of correct responses on cognitive-motor test
Measured: Up to 5 minutes before and up to 5 minutes after intervention
Change in Completion Time
Will be measured in seconds (s)
Measured: Up to 5 minutes before and up to 5 minutes after intervention
Change in Hop distance
Will be measured in meters (m)
Measured: Up to 10 minutes before and up to 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start18 Feb 2025
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Why it stopped: Software and hardware issues in data collection cannot be resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Ripic, University of Miami
- Investigators
- Zachary A Ripic, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748417
- Sponsor's protocol ID
- 20241122
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2024
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the FITLIGHT System and Acute Effects of Cognitive Training on Dual-task Performance in Hopping and Cutting Assessments
- ClinicalTrials.gov ID
- NCT06748417
- Acronym / sponsor ID
- 20241122
- Conditions
- Athletic Injuries
- Keywords
- Reaction time, neurocognitive performance, Agility training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Software and hardware issues in data collection cannot be resolved.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 27 Dec 2024 (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 purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Cognitive Training Followed by Non-stimulating Rest Group | Experimental | Device: Acute Cognitive Training, Other: Non-stimulating RestParticipants will be in this group for approximately 11-14 days |
| Non-stimulating rest followed by acute cognitive training Group | Experimental | Device: Acute Cognitive Training, Other: Non-stimulating RestParticipants will be in this group for approximately 11-14 days |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy as determined by a Physical Activity Readiness Questionnaire
- BMI under 30
Key exclusion criteria (11 listed)
- Color-blindness
- Fractures within the past year
- Musculoskeletal injury limiting sports activity within the past 6 months
- Anterior cruciate ligament (ACL) injuries within the past 5 years
- Medical conditions that do not have physician clearance to participate in exercise
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 |
|---|---|---|
| Acute Cognitive TrainingAlso: FITLIGHTParticipants will receive the intervention in person once within in the study for 30 minutes. During the intervention, participants will receive a cognitive training session consisting of an upper extremity, lower extremity, and whole-body reaction time task. The device (5 LED) will be placed in front of participants in all tasks, and participants will be asked to deactivate lights that illuminate for a period of 30 seconds with 30 seconds of rest. For the upper and lower extremity tasks, these will be repeated on both limbs. The purpose of the tasks are to pre-train reaction time in an isolated fashion, requiring participants to use either hands or feet to deactivate the lights, as well as incorporate whole-body movement in the third task along with a decision-making (color-matching) component. | Device | Acute Cognitive Training Followed by Non-stimulating Rest Group, Non-stimulating rest followed by acute cognitive training Group |
| Non-stimulating RestParticipants will receive the intervention in person once within the study for 30 minutes. During the intervention, participants will watch, while seated, a 30-minute segment of a nature documentary. The purpose of this intervention is to ensure no additional cognitive or movement training that would improve performance on the dual-task test occurs during the intended rest period. | Other | Acute Cognitive Training Followed by Non-stimulating Rest Group, Non-stimulating rest followed by acute cognitive training Group |
Primary outcome
Change in Reaction Time
Time frame: Up to 5 minutes before and up to 5 minutes after intervention
Will be measured in seconds (s)
Change in Percentage of Correct Responses in Cognitive-Motor Running T-test
Time frame: Up to 5 minutes before and up to 5 minutes after intervention
Percentage of correct responses on cognitive-motor test
Change in Completion Time
Time frame: Up to 5 minutes before and up to 5 minutes after intervention
Will be measured in seconds (s)
Change in Hop distance
Time frame: Up to 10 minutes before and up to 10 minutes after intervention
Will be measured in meters (m)
Results and safety
The study was stopped early (reason given: Software and hardware issues in data collection cannot be resolved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
Zachary A Ripic, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Cognitive Training and Non-stimulating Rest in people with Athletic Injuries, run by University of Miami at 1 site in United States.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 Sep 2025. 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 United States. 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 was stopped early (reason given: Software and hardware issues in data collection cannot be resolved.). Results are not available in the source record.
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?
Change in Reaction Time (time frame: Up to 5 minutes before and up to 5 minutes after intervention). The study lists 4 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 12 Sep 2025.