Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

Study Overview
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Brief Summary
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This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.

Official Title
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Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

Conditions
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Concussion, Brain, Brain Injury Traumatic Mild

Intervention / Treatment
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* Behavioral: Cognitive and Motor Dual-task Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria-healthy control: Adults aged 18-34 years of age. Strong history of athletic participation including high school and collegiate varsity and/or club sports Current sport or recreational sport participation at least 3 days per week Willingness to participate in 3 times a week 60 minute exercise program conducted at Courage Kenny Research Center (CKRC). Exclusion Criteria-healthy control: History of concussion. History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson's Disease, etc.) interfering with subject's ability to exercise Unwilling to exercise. At risk for cardiopulmonary disease as defined by the American College of Sports Medicine. Active medical contraindications by self-report after explanation of dual-task exercise program. Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis) by self-report. Inclusion criteria-subjects with mTBI residual symptoms: Adults aged 18-50 years of age. Self-report of some consistent exercise or activity a minimum of 2-3 days per week. 3 weeks to 24 months post most recent concussion seeking treatment at Courage Kenny Rehabilitation Institute (CKRI) clinics Willingness to participate in 3 times a week 60 minute exercise program conducted at CKRC. Exclusion Criteria- subjects with mTBI residual symptoms: History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson Disease, etc.) interfering with subject's ability to exercise Unwilling to exercise. At risk for cardiopulmonary disease as defined by the American College of Sports Medicine. Active medical contraindications by self-report after explanation of dual-task exercise program, Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Traumatic Brain Injury<br>60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Subjects with mTBI residuals will be gently progressed through exercise stations in an individually tailored fashion. | Behavioral: Cognitive and Motor Dual-task Intervention<br>* The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.<br>|
| Other: Healthy Control<br>60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. In addition to providing comparison data, the healthy control, athletic 18-34 year old subjects will be used to identify levels and intensity of progressions of dual-task training stations appropriate for highly trained athletes and military personnel recovering from concussion. | Behavioral: Cognitive and Motor Dual-task Intervention<br>* The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak velocity turns during Instrumented Stand and Walk Test | Change in peak velocity during 180 degree turns during Instrumented Stand and Walk Test in single task (ST) and dual-task (DT) conditions. DT condition involves grid memorization task. | At baseline and after 6 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak turning velocity during walking a custom turning course | Change in peak turning velocity during walking a custom turning course in ST and DT conditions. | At baseline and after 6 weeks of intervention | 
| Change in peak turning velocity during running an agility course | Change in peak turning velocity during running an agility course in ST and DT conditions. | At baseline and after 6 weeks of intervention | 
| Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance | Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance in ST and DT conditions. | At baseline and after 6 weeks of intervention | 
| Change in Beck Depression Inventory-II | Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression. | At baseline and after 6 weeks of intervention | 
| Change in Beck Anxiety Inventory | Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety. | At baseline and after 6 weeks of intervention | 
| Change in Patient-specific Functional Scale | Change in Patient-specific Functional Scale -quantifies the amount of functional limitation secondary to symptoms in up to 3 activities that are relevant to the individual patient. 0 to 10 scale, where 0 = unable to perform activity and 10 = able to perform activity at same level as before injury or problem. | At baseline and after 6 weeks of intervention | 
| Change in Neurobehavioral Symptom Inventory (NSI) | Change in Neurobehavioral Symptom Inventory (NSI): Self-report of residual symptoms in last 2 weeks, a measure of post-TBI symptom severity, 0-4 scale on 22 symptom questions. | At baseline and after 6 weeks of intervention | 
| Rey Auditory Verbal Learning Test Score | Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term) | At baseline | 
| Comprehensive Trails Making Test Score | Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed | Baseline | 
| Verbal Fluency Test Score | Verbal Fluency which tests verbal ability and executive control | Baseline | 
| NAB Digits Forward/Digits Backward Test Score | NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory | Baseline | 
| Stroop Color-Word Test Score | Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control. | Baseline | 
| Wide Range Achievement Test-4 Reading Score | Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect | Baseline |