Brain Injury Traumatic Mild, Concussion, Brain
Conditions
Brief summary
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.
Interventions
BEHAVIORALCognitive and Motor Dual-task Intervention
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.
Sponsors
Allina Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak velocity turns during Instrumented Stand and Walk Test | At baseline and after 6 weeks of intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak turning velocity during running an agility course | At baseline and after 6 weeks of intervention | Change in peak turning velocity during running an agility course in ST and DT conditions. |
| Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance | At baseline and after 6 weeks of intervention | Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance in ST and DT conditions. |
| Change in Beck Depression Inventory-II | At baseline and after 6 weeks of intervention | Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression. |
| Change in Beck Anxiety Inventory | At baseline and after 6 weeks of intervention | Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety. |
| Change in Patient-specific Functional Scale | At baseline and after 6 weeks of intervention | 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. |
| Change in Neurobehavioral Symptom Inventory (NSI) | At baseline and after 6 weeks of intervention | 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. |
| Change in peak turning velocity during walking a custom turning course | At baseline and after 6 weeks of intervention | Change in peak turning velocity during walking a custom turning course in ST and DT conditions. |
| Comprehensive Trails Making Test Score | Baseline | Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed |
| Verbal Fluency Test Score | Baseline | Verbal Fluency which tests verbal ability and executive control |
| NAB Digits Forward/Digits Backward Test Score | Baseline | NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory |
| Stroop Color-Word Test Score | Baseline | Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control. |
| Wide Range Achievement Test-4 Reading Score | Baseline | Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect |
| Rey Auditory Verbal Learning Test Score | At baseline | Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term) |
Countries
United States
Outcome results
None listed