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Clinical Trials/NCT03478059
NCT03478059
Completed
Not Applicable

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

Allina Health System1 site in 1 country24 target enrollmentOctober 31, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injury Traumatic Mild
Sponsor
Allina Health System
Enrollment
24
Locations
1
Primary Endpoint
Change in peak velocity turns during Instrumented Stand and Walk Test
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2017
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret Weightman

Senior Scientific Advisor

Allina Health System

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Change in peak turning velocity during walking a custom turning course(At baseline and after 6 weeks of intervention)
  • Change in peak turning velocity during running an agility course(At baseline and after 6 weeks of intervention)
  • Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance(At baseline and after 6 weeks of intervention)
  • Change in Beck Depression Inventory-II(At baseline and after 6 weeks of intervention)
  • Change in Beck Anxiety Inventory(At baseline and after 6 weeks of intervention)
  • Change in Patient-specific Functional Scale(At baseline and after 6 weeks of intervention)
  • Change in Neurobehavioral Symptom Inventory (NSI)(At baseline and after 6 weeks of intervention)
  • Rey Auditory Verbal Learning Test Score(At baseline)
  • Comprehensive Trails Making Test Score(Baseline)
  • Verbal Fluency Test Score(Baseline)
  • NAB Digits Forward/Digits Backward Test Score(Baseline)
  • Stroop Color-Word Test Score(Baseline)
  • Wide Range Achievement Test-4 Reading Score(Baseline)

Study Sites (1)

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