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

Exploring the Role of Combined Cognitive and Motor 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.

Study Overview

• Status: Completed
• Conditions: Concussion, Brain; Brain Injury Traumatic Mild
• Intervention / Treatment: Behavioral: Cognitive and Motor Dual-task Intervention

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and after 6 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and after 6 weeks of intervention
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.	At baseline and after 6 weeks of intervention
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.	At baseline and after 6 weeks of intervention
Change in Beck Depression Inventory-II	Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.	At baseline and after 6 weeks of intervention
Change in Beck Anxiety Inventory	Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety.	At baseline and after 6 weeks of intervention
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.	At baseline and after 6 weeks of intervention
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.	At baseline and after 6 weeks of intervention
Rey Auditory Verbal Learning Test Score	Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)	At baseline
Comprehensive Trails Making Test Score	Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed	Baseline
Verbal Fluency Test Score	Verbal Fluency which tests verbal ability and executive control	Baseline
NAB Digits Forward/Digits Backward Test Score	NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory	Baseline
Stroop Color-Word Test Score	Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control.	Baseline
Wide Range Achievement Test-4 Reading Score	Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect	Baseline

Collaborators and Investigators

• Sponsor: Allina Health System
• Investigators: Principal Investigator: Margaret M Weightman, PT, PhD, Allina Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: CKMW-1701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No