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

NCT ID: NCT03478059

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive and Motor Dual-task Intervention

Intervention Type: 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

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.

Group Type: OTHER

Cognitive and Motor Dual-task Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• 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

• 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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Margaret Weightman

Senior Scientific Advisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret M Weightman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Allina Health

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CKMW-1701

Identifier Type: -

Identifier Source: org_study_id