- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06748417
FITLIGHT Reliability and Acute Training Effects
September 6, 2025 updated by: Zachary Ripic, University of Miami
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy as determined by a Physical Activity Readiness Questionnaire
- BMI under 30
Exclusion Criteria:
- 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
- Diagnosed cognitive impairments
- Untreated attention deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)
- Prisoners
- Pregnant women
- Smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acute Cognitive Training Followed by Non-stimulating Rest Group
Participants will be in this group for approximately 11-14 days
|
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.
Other Names:
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.
|
|
Experimental: Non-stimulating rest followed by acute cognitive training Group
Participants will be in this group for approximately 11-14 days
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Reaction Time
Time Frame: Up to 5 minutes before and up to 5 minutes after intervention
|
Will be measured in seconds (s)
|
Up to 5 minutes before and up to 5 minutes after intervention
|
|
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
|
Up to 5 minutes before and up to 5 minutes after intervention
|
|
Change in Completion Time
Time Frame: Up to 5 minutes before and up to 5 minutes after intervention
|
Will be measured in seconds (s)
|
Up to 5 minutes before and up to 5 minutes after intervention
|
|
Change in Hop distance
Time Frame: Up to 10 minutes before and up to 10 minutes after intervention
|
Will be measured in meters (m)
|
Up to 10 minutes before and up to 10 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zachary A Ripic, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2025
Primary Completion (Actual)
September 5, 2025
Study Completion (Actual)
September 5, 2025
Study Registration Dates
First Submitted
December 19, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
December 27, 2024
Study Record Updates
Last Update Posted (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 6, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20241122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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