Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care

April 23, 2026 updated by: Laurie King, Oregon Health and Science University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Laurie A King, PhD
  • Phone Number: 503-418-2602
  • Email: kingla@ohsu.edu

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Balance Disorders Laboratory
        • Contact:
        • Contact:
          • Laurie King, PhD, PT, MCR
          • Phone Number: 503-418-2602
          • Email: kingla@ohsu.edu
        • Principal Investigator:
          • Laurie King, PhD, PT, MCR
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • University of Utah Neuromechanics and Applied Locomotion Laboratory
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Peter Fino, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed mTBI (concussion)
  • 18-60 years of age
  • More than 2 weeks from the date of the most recent mTBI
  • Less than 6 months from the most recent mTBI
  • Persisting symptoms from the mTBI

Exclusion Criteria:

  • Injury, medical, or neurological illness that could explain balance issues
  • Moderate to severe substance abuse in the past month
  • Display behavior that would interfere with safety during data collection
  • Significant pain during the study period (> 7/10)
  • Pregnancy
  • Persistent use of medications that cause balance impairment during the study
  • Active in physical therapy services for mTBI symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants with motor physical therapy for mTBI
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
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.
Active Comparator: Standard of care physical therapy treatment 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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Instrumented, Modified Push & Release Test (I-mP&R) - Time to Stability
Time Frame: Weeks 0 and 7 of study
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.
Weeks 0 and 7 of study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change (PGIC)
Time Frame: Week 7 only
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).
Week 7 only
Dizziness Handicap Inventory (DHI)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Neurobehavioral Symptom Inventory (NSI)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Quality of Life after Brain Injury (QOLIBRI)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Activities-specific Balance Confidence Scale (ABC)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
PROMIS - Satisfaction with Participation in Social Roles
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Weeks 0 and 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.
Weeks 0 and 7
Modified Clinical Test of Sensory Integration on Balance (mCTSIB)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Complex Turning Course (CTC)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Complex Uneven Turning Course (CUTC)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
10-Meter Walk Test (10MWT)
Time Frame: Weeks 0 and 7
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
Weeks 0 and 7
Timed Tandem Gait
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Dynamic Visual Acuity (DVA)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Vestibular Ocular Motor Screening (VOMS)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Hybrid Assessment of Mobility (HAM-4)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Automated Neuropsychological Assessment Metric (ANAM)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Gold-Standard Laboratory Assessments: Central Sensorimotor Integration Test (CSMI)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Patient Health Questionnaire-2 (PHQ-2)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Brief Resilience Scale (BRS)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Neck Disability Index (NDI)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Convergence Insufficiency Symptom Survey (CISS)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Fear Avoidance after Concussion Tool (FACT)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Modified Fatigue Impact Scale (MFIS)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Lower Extremity Functional Scale (LEFS)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Dual-Task Questionnaire (DTQ)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Balance Recovery Confidence (BRC) Scale
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
Uneven 10-Meter Walk Test (U10MWT)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
1-Minute Walk Test (1MWT)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
1-Minute Walk Dual-Task (Serial 3s)
Time Frame: Weeks 0 and 7
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.
Weeks 0 and 7
The Visual Vertigo Analogue Scale-6 (VVAS-6)
Time Frame: Week 0 and Week 7
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.
Week 0 and Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Utah
Fort Sam Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurie A King, PhD, PT, MCR, Oregon Health and Science University
  • Principal Investigator: Peter Fino, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#28652
  • HT9425-25-1-0748 (Other Grant/Funding Number: Department of the Army)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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