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

NCT03478059 | Completed

• 1 other identifier: CKMW-1701
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury Traumatic Mild; Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

Mild Traumatic Brain Injury

EXPERIMENTAL

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

Healthy Control

OTHER

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

Interventions

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.

Healthy Control; Mild Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Adults aged 18-50 years of age.
• Self-report of some consistent exercise or activity a minimum of 2-3 days per week.
• 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.
• 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).

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Margaret M Weightman, PT, PhD

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientific Advisor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: October 31, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

US (1)