Clinical trial NCT03478059: Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Official title: Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury Traumatic Mild
Concussion, Brain
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change in peak velocity turns during Instrumented Stand and Walk Test
timeFrame: At baseline and after 6 weeks of intervention
Secondary outcomes:
measure: Change in peak turning velocity during walking a custom turning course
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in peak turning velocity during running an agility course
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in Beck Depression Inventory-II
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in Beck Anxiety Inventory
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in Patient-specific Functional Scale
timeFrame: At baseline and after 6 weeks of intervention
measure: Change in Neurobehavioral Symptom Inventory (NSI)
timeFrame: At baseline and after 6 weeks of intervention
measure: Rey Auditory Verbal Learning Test Score
timeFrame: At baseline
measure: Comprehensive Trails Making Test Score
timeFrame: Baseline
measure: Verbal Fluency Test Score
timeFrame: Baseline
measure: NAB Digits Forward/Digits Backward Test Score
timeFrame: Baseline
measure: Stroop Color-Word Test Score
timeFrame: Baseline
measure: Wide Range Achievement Test-4 Reading Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Margaret M Weightman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: