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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Center of Pressure (COP) control
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.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,214 Total Patients Enrolled
David J. Clark, DScPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
121 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to participate in this experiment?
"Candidates for this medical trial must be aged between 50 and 65, and have a history of traumatic brain injury. 70 patients are required to complete the study's requirements."
Answered by AI
Are candidates of legal age accepted for enrollment in this trial?
"For enrollment in this trial, patients must be 50-65 years old. Other trials targeting minors and seniors constitute 61 studies for those under 18 and 227 for over 65s respectively."
Answered by AI
Are there any openings to enroll in this experiment currently?
"According to clinicaltrials.gov, this study is no longer recruiting participants since it was last updated on February 7th 2023. Nevertheless, 309 other trials are open for enrolment at present."
Answered by AI
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