The goal of this study is to learn whether a home-based rhythmic auditory stimulation (RAS) program using the MR-001 device can help improve walking, balance, and other health outcomes in adults with moderate to severe traumatic brain injury (TBI). The study will also look at how safe and feasible it is for people with TBI to use this device at home. The purpose is to determine the safety, feasibility, and adherence of a home-based, music-guided RAS intervention and to explore preliminary effects on mobility, cognition, mood, enjoyment, perceived change, and cortical excitation.
The main questions this study aims to answer are:
1. Does training with the MR-001 device improve walking endurance, gait speed, and balance? 2. Does the intervention improve cognition, mood, fatigue, and participants' impression of change? 3. How enjoyable is the training experience for participants? 4. How does the brain respond to walking with versus without rhythmic auditory stimulation?
Researchers will compare the MR-001 intervention to a waitlist control group to see whether the device leads to improvements beyond usual activity.
Participants will:
1. Use the MR-001 device at home for 30 minutes, three times per week for eight weeks 2. Complete walking, balance, cognitive, and questionnaire assessments 3. Participate in two lab sessions using functional near-infrared spectroscopy (fNIRS) to measure brain activity during walking 4. Provide two fasting blood samples to measure BDNF, a biomarker related to neuroplasticity 5. Complete study visits at baseline, after eight weeks, and (for the waitlist group) after their treatment period
This study will help determine whether a home-based, music-guided walking program can support long-term mobility and recovery after TBI.
have a moderate to severe TBI that required inpatient rehabilitation;
able to ambulate independently, with or without an assistive device.;
ambulating < 1.4 m/s (comfortable walking speed)
demonstrate a reciprocal gait pattern;
Uncontrolled cardiopulmonary, metabolic, or infectious disorder;
history of orthopedic or additional neurological disorder that limited motor function before TBI;
any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns;
uncontrolled seizure disorder;
Sequential
Home-Based Rhythmic Auditory Stimulation
DeviceParticipants will complete baseline tests, then be randomly assigned to start training right away or after an eight-week waitlist period. Those in the treatment group will learn to use the MR-001 device and train at home for 30 minutes, three times per week for eight weeks, with weekly check-ins for support and safety. The waitlist group will repeat testing after eight weeks, then complete the same training program. All participants will complete enjoyment surveys, two fNIRS sessions to measure brain activity while walking with and without the device, and two fasting blood draws to measure BDNF levels.
Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate
Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate to assess for safety, feasibility, and adherence.
10MWT
The 10-Meter Walk Test (10MWT) is a standardized measure of gait speed. This test demonstrates excellent test-retest and interrater reliability, with interclass correlation coefficients (ICC) of 0.95 and 0.99 , respectively in individuals with TBI. An MCID of 0.15 meters/second in comfortable walking speed has been reported.
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14-task performance measure that objectively assesses static and dynamic balance and fall risk in adults. Item-level scores range from 0-4 with higher total scores indicating better balance. BBS has excellent test-retest reliability (ICC = 0.99) in TBI and a standard error of measurement of 1.65.
6minWT
The 6-Minute Walk Test (6MWT) measures distance walked (in meters) over 6 minutes as a sub-maximal test of aerobic capacity and endurance. This test shows excellent test re-test reliability (ICC = 0.94) for the TBI population. The MCID is 34.4 meters for the stroke population.
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a ten-task dynamic balance assessment with item-level scores ranging from 0-3 and higher scores indicating greater balance. The FGA has excellent intra-rater (ICC = 0.94) and interrater reliability (ICC = 0.97).
Brief Test of Adult Cognition by Telephone (BTACT)
The Brief Test of Adult Cognition by Telephone (BTACT) assesses multiple cognitive dimensions central for effective functioning across adulthood: episodic memory, working memory, reasoning, verbal fluency, and executive function. Although originally designed for telephone use, evidence establishing construct validity has been published in a subsample of individuals with TBI who were tested in person.
Brief Symptom Inventory-18 (BSI 18)
The Brief Symptom Inventory-18 (BSI 18) is a brief self-report measure of psychological distress assessing somatization, depression, and anxiety, with a Global Severity Index (GSI) as the primary outcome. It has low burden (\~3-5 minutes) and strong psychometric support. Across populations, the GSI demonstrates excellent reliability (α≈0.91), with acceptable subscale reliability. In traumatic brain injury (TBI), the GSI shows strong internal consistency (α=0.84-0.91) and good construct validity
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) has 21 items rated on a 5-point scale with total scores ranging from 0-84 (higher score indicates greater fatigue). The mFIS assesses the perceived impact of fatigue on physical, cognitive and psychosocial functioning over the past 4 weeks. It has excellent internal consistency, good test-rest reliability and a minimally important difference of 4.00. This pencil and paper survey takes 2-10 minutes to complete.
Participant Global Impression of Change (PGIC)
Participant Global Impression of Change (PGIC) scales have been recommended for use as a core outcome measure in rehabilitation studies to improve the applicability of information from clinical trials to clinical practice. We will utilize a 7-point scale: "With respect to walking and balance function, how would you describe yourself compared to before the treatment began?" with -3 representing very much worse, 0 representing unchanged, and +3 representing very much better.
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Craig Hospital
Lead sponsor
MedRhythms, Inc.
Collaborator
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