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Complex Balance Tasks for Traumatic Brain Injury
N/A
Recruiting
Led By David J. Clark, DSc
Research Sponsored by VA Office of Research and Development
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 cop control, measured immediately following a single intervention session (the session will include 30 minutes)
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore how a moderate TBI in early/middle adulthood can affect brain health/function in older age, with the goal of designing interventions to preserve brain health in TBI survivors.
Who is the study for?
This trial is for individuals aged 50-65 who had a moderate traumatic brain injury (TBI) at least 15 years ago, consider themselves fully recovered, and can travel to the research site. They must have good balance confidence and cognitive function scores. People with severe health issues like uncontrolled hypertension or diabetes, recent cancer treatment (except certain skin cancers), substance abuse, or other conditions affecting balance or cognition cannot join.
What is being tested?
The study tests how well people who had a TBI in the past perform on complex balance tasks and cognitive tests despite feeling recovered. It aims to understand aging effects after TBI and develop future rehabilitative interventions for maintaining brain health.
What are the potential side effects?
Since this trial involves practice-based learning of complex balance tasks rather than medication or invasive procedures, side effects are minimal but may include fatigue or muscle soreness from physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline cop control, measured immediately following a single intervention session (the session will include 30 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline cop control, measured immediately following a single intervention session (the session will include 30 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Center of Pressure (COP) control
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Balance InterventionExperimental Treatment1 Intervention
Participants with TBI history and without TBI history will both complete the same intervention.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,427,218 Total Patients Enrolled
David J. Clark, DScPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
161 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a moderate brain injury from a closed-head impact over 15 years ago.My BMI is over 35, indicating severe obesity.I have a neurological condition, but it's not a moderate traumatic brain injury.I am currently experiencing severe PTSD symptoms.I have diabetes that is not well-controlled.I am currently in physical therapy for leg function.I have not had a heart attack or major heart surgery in the last year.I have completed the OSU TBI-ID test confirming I had a traumatic brain injury.I haven't taken certain medications in the last 6 months.I regularly use steroid medications.I do not have health issues affecting my balance, thinking, or eye movements.I am between 50 and 65 years old.I am confident in my balance for various activities.I live at home and can travel to the study location.I do not have an uncontrolled major depressive episode or a severe psychiatric illness not related to TBI.My heart condition is not stable.I haven't had cancer treatment in the past year, except for non-dangerous skin cancers.I am on dialysis for kidney failure.My blood pressure is high and not controlled by medication.My severe arthritis affects my ability to move or balance.I need extra oxygen to breathe properly.I have had a bone fracture in the last year.I do not have hip replacements or metal implants that could affect medical assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Balance Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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