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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

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03478059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Rey Auditory Verbal Learning Test Score [ Time Frame: At baseline ]
    Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)
  • Comprehensive Trails Making Test Score [ Time Frame: Baseline ]
    Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed
  • Verbal Fluency Test Score [ Time Frame: Baseline ]
    Verbal Fluency which tests verbal ability and executive control
  • NAB Digits Forward/Digits Backward Test Score [ Time Frame: Baseline ]
    NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Official Title  ICMJE Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injury Traumatic Mild
  • Concussion, Brain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Cognitive and Motor Dual-task Intervention
  • 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.

    Intervention: Behavioral: Cognitive and Motor Dual-task Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Margaret M Weightman, PT, PhD 612-863-6525 margaret.weightman@allina.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03478059
Other Study ID Numbers  ICMJE CKMW-1701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret Weightman, Allina Health System
Study Sponsor  ICMJE Allina Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margaret M Weightman, PT, PhD Allina Health
PRS Account Allina Health System
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP