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Completed

NCT Number: NCT03478059

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

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.

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Key information

Conditions

Brain Injury Traumatic Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Brain Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive and Motor Dual-task Intervention

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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