Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
NCT ID: NCT05062148
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-09-30
2022-06-07
Brief Summary
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Detailed Description
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Phase I - Initial Injury: High school aged athletes will be recruited from a WVU clinic in the acute phase of the athletes injury. Severe cases such as those with hemorrhaging and memory loss will be excluded from the study.
Phase II - Pre-intervention: Patients will be randomly assigned using R software (https://www.r-project.org) to three groups - Float-REST, PBM, or no intervention. Upon each subjects' first visit to Rockefeller Neuroscience Institute (RNI) a brief health questionnaire regarding the mechanism of injury will be administered (see below), the Rivermead Postconcussive Symptom Inventory (Rivermead), and the pre-intervention testing battery. All subjects will be instructed to complete the Rivermead as a daily log on a smartphone to monitor symptoms and follow the physician's orders for recovery (limited screen time, decreased homework load, etc.). Subjects will also be given a wearable sleep tracking device and instructed to wear it each night. Float-REST subjects will be shown the float tanks and will be given the opportunity to float for 5-10 minutes to become familiar with the sensation. PBM subjects will be shown the PBM bed and be permitted to test the brightness of the device. All subjects wishing to test either the PBM or the Float-REST will be required to take the SCAT5 Symptom Checklist first and not meet the exclusionary criteria contained in the Data Monitoring Plan.
Phase III - Intervention: All subjects will return to RNI three times per week. Subjects receiving Float-REST will float for 60 minutes, those receiving PBM will undergo a 20-minute therapy session, and both will complete the weekly testing (Table 1) afterwards. Subjects in the no intervention group will complete the weekly testing only. This will continue until the subjects' physicians clear them to return to play. The duration for return to play is an outcome measure of interest as it will expectedly vary subject to subject. If a recovery intervention is capable of shortening the time an athlete takes to return to competition, that particular intervention may be considered an effective strategy for accelerating recovery periods after sustaining a sports-related concussion.
Phase IV - Post-intervention: Once a subject has been cleared to return to play, the subject will come to RNI one final time and complete the post-concussion battery (Table 1). Upon completion, all patient's scores will be analyzed using R software (https://www.r-project.org). It is expected that those receiving Float-REST and/or PBM will have a greater improvement of cognitive scores than those just following physician orders.
End of Study: When the physician provides a medical clearance for the athlete to return to competition that will subsequently cease further data collection for that individual for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
All subjects will return to RNI three times per week (intervention visits). Subjects receiving Float-REST will float for 60 minutes, those receiving PBM will undergo a 20-minute therapy session, and both will complete the weekly testing afterwards. Subjects in the no intervention group will complete the weekly testing only. This will continue until the subjects' physicians clear them to return to play.
BASIC_SCIENCE
NONE
Study Groups
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Standard of Care
Subjects will follow the standard of care, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
No interventions assigned to this group
Float-REST
Subjects will do Flotation Restricted Environmental Stimulation Therapy, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Float-REST
Subjects receiving Float-REST will float for 60 minutes three times a week.
Photobiomodulation
Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Photobiomodulation
Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.
Interventions
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Float-REST
Subjects receiving Float-REST will float for 60 minutes three times a week.
Photobiomodulation
Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
17 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Responsible Party
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Locations
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Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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1904545091
Identifier Type: -
Identifier Source: org_study_id