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Brain Injury Therapy of Exercise and Enriched Environment (BITEEE Trial)
N/A
Waitlist Available
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 9 weeks.
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. A series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.
Eligible Conditions
- Brain Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 9 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 9 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Trail Making Part B
Secondary study objectives
Quality of Life in Brain Injury Questionnaire
Other study objectives
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
NIH Toolbox Standing Balance Test
Repeatable Battery for the Assessment of Neuropsychological Status
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Exercise and EnrichmentExperimental Treatment1 Intervention
Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.
Group II: ExerciseExperimental Treatment1 Intervention
Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.
Group III: Delayed ExerciseExperimental Treatment1 Intervention
Delayed Exercise Group will have exercise as intervention. People be tested before the start of, and after the end of the eight (8) weeks then after exercise intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820
Find a Location
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
314 Previous Clinical Trials
110,855 Total Patients Enrolled
Jean Peduzzi-Nelson, Ph.D.Study DirectorWayne State University I