Back to resultsDual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Primary Purpose
Brain Injury Traumatic Mild, Concussion, Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive and Motor Dual-task Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury Traumatic Mild
Eligibility Criteria
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).
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mild Traumatic Brain Injury
Healthy Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Change in Beck Depression Inventory-II
Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.
Change in Beck Anxiety Inventory
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
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)
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
Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)
Comprehensive Trails Making Test Score
Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed
Verbal Fluency Test Score
Verbal Fluency which tests verbal ability and executive control
NAB Digits Forward/Digits Backward Test Score
NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory
Stroop Color-Word Test Score
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
Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03478059
Brief Title
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Official Title
Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allina Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury Traumatic Mild, Concussion, Brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild Traumatic Brain Injury
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and Motor Dual-task Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in peak velocity turns during Instrumented Stand and Walk Test
Description
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.
Time Frame
At baseline and after 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in peak turning velocity during walking a custom turning course
Description
Change in peak turning velocity during walking a custom turning course in ST and DT conditions.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in peak turning velocity during running an agility course
Description
Change in peak turning velocity during running an agility course in ST and DT conditions.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance
Description
Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance in ST and DT conditions.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in Beck Depression Inventory-II
Description
Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in Beck Anxiety Inventory
Description
Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in Patient-specific Functional Scale
Description
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.
Time Frame
At baseline and after 6 weeks of intervention
Title
Change in Neurobehavioral Symptom Inventory (NSI)
Description
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.
Time Frame
At baseline and after 6 weeks of intervention
Title
Rey Auditory Verbal Learning Test Score
Description
Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)
Time Frame
At baseline
Title
Comprehensive Trails Making Test Score
Description
Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed
Time Frame
Baseline
Title
Verbal Fluency Test Score
Description
Verbal Fluency which tests verbal ability and executive control
Time Frame
Baseline
Title
NAB Digits Forward/Digits Backward Test Score
Description
NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory
Time Frame
Baseline
Title
Stroop Color-Word Test Score
Description
Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control.
Time Frame
Baseline
Title
Wide Range Achievement Test-4 Reading Score
Description
Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M Weightman, PT, PhD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
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Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
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