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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478059
• Other study ID #: CKMW-1701
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Concussion, Brain
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rey Auditory Verbal Learning Test Score	Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)	At baseline
Secondary	Comprehensive Trails Making Test Score	Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed	Baseline
Secondary	Verbal Fluency Test Score	Verbal Fluency which tests verbal ability and executive control	Baseline
Secondary	NAB Digits Forward/Digits Backward Test Score	NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory	Baseline
Secondary	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
Secondary	Wide Range Achievement Test-4 Reading Score	Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect	Baseline