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

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ClinicalTrials.gov Identifier: NCT03478059
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Margaret Weightman, 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.

Condition or disease Intervention/treatment Phase
Brain Injury Traumatic Mild Concussion, Brain Behavioral: Cognitive and Motor Dual-task Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Mild Traumatic Brain Injury

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
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.

Healthy Control

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
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 Measures :
  1. Change in peak velocity turns during Instrumented Stand and Walk Test [ Time Frame: 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 :
  1. Change in peak turning velocity during walking a custom turning course [ Time Frame: At baseline and after 6 weeks of intervention ]
    Change in peak turning velocity during walking a custom turning course in ST and DT conditions.

  2. Change in peak turning velocity during running an agility course [ Time Frame: At baseline and after 6 weeks of intervention ]
    Change in peak turning velocity during running an agility course in ST and DT conditions.

  3. Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance [ Time Frame: 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.

  4. Change in Beck Depression Inventory-II [ Time Frame: At baseline and after 6 weeks of intervention ]
    Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.

  5. Change in Beck Anxiety Inventory [ Time Frame: 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.

  6. Change in Patient-specific Functional Scale [ Time Frame: 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.

  7. Change in Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 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.

  8. Rey Auditory Verbal Learning Test Score [ Time Frame: At baseline ]
    Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)

  9. Comprehensive Trails Making Test Score [ Time Frame: Baseline ]
    Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed

  10. Verbal Fluency Test Score [ Time Frame: Baseline ]
    Verbal Fluency which tests verbal ability and executive control

  11. NAB Digits Forward/Digits Backward Test Score [ Time Frame: Baseline ]
    NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory

  12. Stroop Color-Word Test Score [ Time Frame: Baseline ]
    Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control.

  13. Wide Range Achievement Test-4 Reading Score [ Time Frame: Baseline ]
    Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478059


Contacts
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Contact: Margaret M Weightman, PT, PhD 612-863-6525 margaret.weightman@allina.com

Locations
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United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Margaret Weightman, PT, PhD         
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Margaret M Weightman, PT, PhD Allina Health

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Responsible Party: Margaret Weightman, Senior Scientific Advisor, Allina Health System
ClinicalTrials.gov Identifier: NCT03478059     History of Changes
Other Study ID Numbers: CKMW-1701
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Concussion
Wounds and Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases