NCT07549529 · Oregon Health and Science University
Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care
What this study is about
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).
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- Persistent use of medications that cause balance impairment during the study
- Active in physical therapy services for mTBI symptoms
Where
- Portland, Oregon
- Salt Lake City, Utah
Collaborators
University of Utah, Fort Sam Houston
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations