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

Not Applicable

Completed

• Conditions: Concussion, Brain; Brain Injury Traumatic Mild
• Interventions: Behavioral: Cognitive and Motor Dual-task Intervention

• Registration Number: NCT03478059
• Lead Sponsor: Allina Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-31
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Traumatic Brain Injury	Cognitive and Motor Dual-task Intervention	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.
Healthy Control	Cognitive and Motor Dual-task Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Rey Auditory Verbal Learning Test Score	At baseline	Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)
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

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States