An interventional study of Motor Activation Physical Therapy for mTBI and Standard of Care Physical Therapy for mTBI in Mild Traumatic Brain Injury (mTBI) and Concussion, Mild Traumatic Brain Injury, sponsored by Oregon Health and Science University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
This work will address an important gap in physical therapy rehabilitation after concussion. Physical therapy usually focuses on how the brain processes sensory information such as inner ear and vision for balance rehabilitation, but our recent research shows that people with imbalance more often have a problem with how they can respond to imbalance (i.e., motor activation). While there are complex laboratory tools to test motor activation for balance, these tests are not practical for the clinic. The goal of this study is to create both an exercise intervention focused on motor activation after concussion and simple, but objective and instrumented (wearable sensors), clinical measures of motor activation. Objectives: This research study has three aims. 1) The investigators and study team will develop an exercise program to improve the problems with how one's body responds to imbalance (i.e., improve motor activation) after a concussion. The study team will use a Community Based Participatory Research (CBPR) approach by collaborating with a team of people with a broad range of experience related to concussion. The study team will form a Community Advisory Board (CAB) that will include patients who have had a concussion, healthcare professionals with expertise in concussion, and healthcare administrators. The CAB will contain people working in the military and civilians. 2) The investigators will compare our new motor-focused physical therapy intervention to the standard sensory focused balance intervention. The goal is to determine which intervention program is more effective in treating balance problems after a concussion. The investigators hypothesize that the motor-focused program will help patients more compared to the sensory program. 3) The investigators and study team will create and test several balance tests that can be used in the clinical without expensive research equipment to our standard research-based motor activation tests. This aim will allow the study team to determine if the clinical tests perform as well as the research-grade tests. To make the test useful to clinicians, the study team will use simpler technology like smart-phone applications, wearable sensors, and virtual reality goggles that are both affordable and practical for healthcare providers.
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Exclusion Criteria:
Participants in this arm of the study will receive physical therapy focused on reactive and dynamic balance exercises to improve motor activation for stability.
Other: Motor Activation Physical Therapy for mTBI
This arm of the study will receive physical therapy in accordance with current clinical practice guidelines for mTBI treatment.
Other: Standard of Care Physical Therapy for mTBI
The motor activation program will complete approximately 12 rehabilitation sessions involving a novel physical therapy program with exercises targeted to improve dynamic and reactive balance.
This arm of the study will complete approximately 12 rehabilitation sessions involving the the current clinical practice guidelines for mTBI treatment including exercises for aerobic tolerance, neck pain, balance, and movement.
Instrumented, Modified Push & Release Test (I-mP&R) - Time to Stability
The Instrumented, Modified Push \& Release (I-mP\&R) test quantifies reactive balance and motor activation by measuring the time required to regain stability following a controlled loss of balance. Participants are leaned just beyond their limit of stability, instructed to close their eyes, and then released unexpectedly. Wearable inertial sensors placed on the lumbar spine and bilateral feet are used to determine the instant of release and the first instant of stability, defined as lumbar acceleration magnitude less than 1.07 times gravity and angular velocity magnitude less than 14 degrees per second. The test is performed in four directions (forward, backward, left, right), and the median Time to Stability across all directions is retained as the primary outcome.
Time frame: Weeks 0 and 7 of study
Patient Global Impression of Change (PGIC)
A single-item, seven-point Likert scale in which participants rate their perceived overall change in health status following intervention. Scores range from 1 (no change) to 7 (a great deal of change).
Time frame: Week 7 only
Dizziness Handicap Inventory (DHI)
A 25-item self-report questionnaire assessing the self-perceived dizziness-related problems. Items are scored from 0 to 4, where 0 indicates no problems, and 4 indicates problems occurring always. Total scores range from 0-100, with higher scores indicating greater perceived dizziness-related problems.
Time frame: Weeks 0 and 7
Neurobehavioral Symptom Inventory (NSI)
A 22-item self-report questionnaire assessing the severity of post-concussive symptoms. Each item is rated from 0 (none) to 4 (very severe), with higher total scores indicating greater symptom burden.
Time frame: Weeks 0 and 7
Quality of Life after Brain Injury (QOLIBRI)
A 37-item questionnaire assessing quality of life across six domains including cognition, emotions, daily life and autonomy, social relationships, feelings, and physical problems. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Time frame: Weeks 0 and 7
Activities-specific Balance Confidence Scale (ABC)
A self-report questionnaire that assesses an individual's confidence in performing 16 everyday activities without losing balance or becoming unsteady. Each item is rated from 0% (no confidence) to 100% (complete confidence). The total score is calculated as the mean of all items, with lower scores indicating reduced balance confidence.
Time frame: Weeks 0 and 7
PROMIS - Satisfaction with Participation in Social Roles
A self-report questionnaire assessing participants' perceived satisfaction with their ability to engage in usual social roles and activities over the past 7 days. Items are rated on a Likert scale, with higher scores indicating greater satisfaction with participation.
Time frame: Weeks 0 and 7
Generalized Anxiety Disorder-7 (GAD-7)
A 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past two weeks. Each item is scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Time frame: Weeks 0 and 7
Modified Clinical Test of Sensory Integration on Balance (mCTSIB)
This test assesses the relative contributions of visual, vestibular, and somatosensory inputs to postural control during standing. Participants stand with feet together under four conditions: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam surface, and eyes closed on a foam surface. Performance is evaluated based on the ability to maintain balance for up to 30 seconds per condition. When wearable sensors are used, postural sway measures may also be derived.Total time across all conditions is recorded, with longer durations indicating better balance performance.
Time frame: Weeks 0 and 7
Complex Turning Course (CTC)
Evaluates walking performance along a prescribed path involving multiple turns of 135, 90, and 45 degree angles. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived.Lap completion time and total completion time are recorded.
Time frame: Weeks 0 and 7
Complex Uneven Turning Course (CUTC)
A clinical mobility assessment designed to evaluate walking and turning performance under increased balance demands. Participants walk a prescribed path involving multiple turns of 45, 90, 135 degree angles on an uneven walking surface. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived.Performance is quantified using completion time, with faster times indicating better mobility and balance performance.
Time frame: Weeks 0 and 7
10-Meter Walk Test (10MWT)
A clinical assessment of gait speed measured over a 10-meter level walkway at a self-selected pace. Time is recorded after the participants foot crosses two meters and is recording is stopped after the participant crosses 8 meters. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived. Three trials are completed
Time frame: Weeks 0 and 7
Timed Tandem Gait
A clinical assessment requiring heel-to-toe walking along a 3-meter line with the goal of keeping heel and toe together and not stepping off the line as accurately and quickly as possible. Once the participant crosses the end of the 3 m line, they quickly turn 180° and return to the starting point using the same gait. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived. Time to completion is recorded, with shorter times indicating better performance.
Time frame: Weeks 0 and 7
Dynamic Visual Acuity (DVA)
This test assesses gaze stability during active head movements by measuring the loss of visual acuity relative to static visual acuity. Participants read an eye chart (ETDRS in this study) while performing horizontal head rotations at a standardized frequency. The change in the number of lines read compared to static visual acuity is recorded, with a loss of three or more lines considered clinically significant. Smaller losses indicate better vestibulo-ocular function.
Time frame: Weeks 0 and 7
Vestibular Ocular Motor Screening (VOMS)
A clinician-administered screening tool that evaluates symptom provocation associated with vestibular and ocular motor function. Baseline symptoms (headache, dizziness, nausea, fogginess) are rated on a 0-10 scale. After each task (smooth pursuits, saccades, near point of convergence, vestibulo-ocular reflex, and visual motion sensitivity), participants re-rate symptoms on the same scale. Total and change scores are calculated, with higher scores indicating greater symptom provocation.
Time frame: Weeks 0 and 7
Hybrid Assessment of Mobility (HAM-4)
A performance-based mobility assessment that combines multiple challenging gait and balance tasks, including fast walking, backward walking, pivot turn, and walking with head turns. Performance is scored across four components, with a maximum total score of 14. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived.Higher scores indicate better overall mobility and balance performance.
Time frame: Weeks 0 and 7
Automated Neuropsychological Assessment Metric (ANAM)
A computerized neurocognitive assessment battery used to evaluate cognitive domains commonly affected following mild traumatic brain injury, including attention, processing speed, working memory, and reaction time. The assessment is administered on a computer or tablet, and performance metrics are automatically recorded. Higher scores and faster reaction times generally indicate better cognitive performance, depending on the specific subtest.
Time frame: Weeks 0 and 7
Gold-Standard Laboratory Assessments: Central Sensorimotor Integration Test (CSMI)
A laboratory-based balance assessment using pseudorandom stimuli including surface and/or visual tilt to quantify sensory weighting, motor activation parameters (stiffness and damping), and feedback time delay during standing balance.
Time frame: Weeks 0 and 7
Patient Health Questionnaire-2 (PHQ-2)
A 2-item self-report questionnaire used to assess the severity of depressive symptoms over the past two weeks. Each item is scored on a 3-point Likert scale from 0 (not at all) to 3 (nearly every day), yielding a total score range of 0 to 6. Higher scores indicate greater severity of depressive symptoms.
Time frame: Weeks 0 and 7
Brief Resilience Scale (BRS)
A 6-item self-report questionnaire designed to assess an individual's ability to recover or "bounce back" from stress. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores are averaged across items, with higher scores indicating greater resilience.
Time frame: Weeks 0 and 7
Neck Disability Index (NDI)
A 10-item self-report questionnaire that assesses neck-related disability during daily activities. Each item is scored from 0 (no disability) to 5 (complete disability), resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. Scores may also be expressed as a percentage of the maximum score.
Time frame: Weeks 0 and 7
Convergence Insufficiency Symptom Survey (CISS)
A 15-item self-report questionnaire assessing symptoms associated with convergence insufficiency during near-vision activities. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (always), with total scores ranging from 0 to 60. Higher scores indicate greater symptom severity, and scores of 21 or higher are suggestive of convergence insufficiency.
Time frame: Weeks 0 and 7
Fear Avoidance after Concussion Tool (FACT)
A 28-item self-report questionnaire that assesses fear-avoidance beliefs and behaviors related to physical activity, symptom exacerbation, and return to activity following concussion. The measure evaluates the extent to which individuals avoid movement or activities due to fear of worsening symptoms or re-injury. Higher scores indicate greater fear-avoidance.
Time frame: Weeks 0 and 7
Modified Fatigue Impact Scale (MFIS)
A self-report questionnaire that assesses the perceived impact of fatigue on physical, cognitive, and psychosocial functioning over the past 4 weeks. The scale consists of 21 items rated on a Likert scale from 0 (never) to 4 (almost always). Total scores range from 0 to 84, with higher scores indicating greater fatigue impact.
Time frame: Weeks 0 and 7
Lower Extremity Functional Scale (LEFS)
A self-report questionnaire assessing perceived difficulty performing everyday activities that require lower extremity function. The scale consists of 20 items; each scored from 0 (extreme difficulty or unable to perform activity) to 4 (no difficulty). Total scores range from 0 to 80, with higher scores indicating better lower extremity function.
Time frame: Weeks 0 and 7
Dual-Task Questionnaire (DTQ)
A self-report measure with 10 items assessing participants' perceived difficulty performing activities that require simultaneous motor and cognitive demands (dual-tasking) in daily life. Items are scored from 0 (never) to 4 (very often and there is also the ability to select no applicable (N/A). Participants are asked to rate how challenging it is to walk, balance, or move while performing an additional cognitive task (e.g., talking, thinking, or concentrating). Higher scores indicate greater perceived dual-task difficulty.
Time frame: Weeks 0 and 7
Balance Recovery Confidence (BRC) Scale
A self-report questionnaire that assesses an individual's confidence in their ability to recover balance to prevent a fall across a range of everyday situations. The scale consists of 19 scenario-based items, each describing a potential loss-of-balance situation (e.g., slips, trips, perturbations during walking or standing). Participants rate their confidence in recovering balance for each scenario on an 11-point numeric scale from 0 to 10, where 0 indicates cannot do at all, and 10 indicates highly certain can do. Total and average scores are calculated, with higher scores indicating greater balance recovery confidence.
Time frame: Weeks 0 and 7
Uneven 10-Meter Walk Test (U10MWT)
Evaluates walking performance over a 10-meter uneven walking surface. Participants are instructed to walk at a self-selected comfortable pace. Performance is quantified using the time required to complete the walkway, with shorter times indicating better gait performance under increased balance demands. Time is recorded after the participants foot crosses two meters and is recording is stopped after the participant crosses 8 meters. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived. Three trials are completed.
Time frame: Weeks 0 and 7
1-Minute Walk Test (1MWT)
An over-ground walking performance and functional mobility; Participants are instructed to walk continuously for one minute at a self-selected comfortable pace along a defined walking course. Performance is quantified using distance walked during the one-minute period. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived. Greater distance indicates better walking performance.
Time frame: Weeks 0 and 7
1-Minute Walk Dual-Task (Serial 3s)
Assesses walking performance under divided attention. Participants are instructed to walk continuously for one minute at a self-selected comfortable pace while simultaneously performing a cognitive task consisting of serial subtraction by 3's. Walking performance is quantified using distance covered during the one-minute period. When wearable sensors are used, spatiotemporal gait, and/or postural sway measures may also be derived. Reduced walking distance and/or altered gait parameters reflect greater dual-task interference.
Time frame: Weeks 0 and 7
The Visual Vertigo Analogue Scale-6 (VVAS-6)
A self-report questionnaire that assesses how dizzy a person would feel in different situations. The participant is asked to rate how dizzy they would feel from 0-10. This questionnaire is six items and there is also an option to select that the situation would not apply to the participant as well. A higher score indicates more impairment with total score ranging from 0-60, those that score 37 and above are considered to have vestibular impairment.
Time frame: Week 0 and Week 7
Plan to share: Undecided — We do not have a plan in place to share IPD. However, if there is a request for IPD, the PI will review this request and initiate the appropriate data use agreements between institutions.
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