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Exercises for Concussion (TECHS Trial)
N/A
Recruiting
Research Sponsored by Northeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ambulatory without pain or the assistance of walking devices
No brain bleeds
Must not have
Prior diagnosis of cognitive or physical disability
Not fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how two different types of physical exercise impact the brain, thinking abilities, and patient-reported outcomes after a mild traumatic brain injury in adults living in the community. The study will test
Who is the study for?
This trial is for adults living in the community who have experienced a mild traumatic brain injury (mTBI) or concussion. The study seeks participants to test exercise interventions aimed at improving brain and cognitive recovery.
What is being tested?
The study is testing two types of physical exercises: balance and aerobic exercises. Participants will follow a 3-month exercise protocol to see which type better aids recovery after mTBI.
What are the potential side effects?
While not explicitly mentioned, potential side effects may include muscle soreness, fatigue, dizziness, or exacerbation of any pre-existing conditions during physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk without pain or the need for help like canes or walkers.
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I have not had any bleeding in my brain.
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I have not been diagnosed with any neurological diseases.
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I had a concussion within the last year.
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I am between 18 and 55 years old.
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My vision is 20/20, with or without correction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a cognitive or physical disability.
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I am not fluent in English.
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I have had a stroke or brain bleed in the past.
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I regularly use a device to help me walk.
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I have a history of fainting spells.
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I have not had a heart attack or any heart surgery in the last year.
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I have a neurological condition like MS, Parkinson's, or dementia.
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I have a severe head injury or a skull fracture with bleeding in the brain.
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I am currently being treated for a heart condition or blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hopkins Verbal Learning Test
Letter and Category Fluency Test
Trail Making Test
Secondary study objectives
Brain Morphology
Cerebral Blood Flow
Daily Physical Activity Levels- Accelerometers
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise GroupExperimental Treatment1 Intervention
Group II: Balance Exercise GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1350
Find a Location
Who is running the clinical trial?
Northeastern UniversityLead Sponsor
99 Previous Clinical Trials
71,052 Total Patients Enrolled