Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motor Activation Physical Therapy for mTBI, Standard of Care Physical Therapy for mTBI.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury (mTBI), Concussion, Mild Traumatic Brain Injury. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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]
Secondary outcome measures (12)
- Patient Global Impression of Change (PGIC) [Time frame: Week 7 only]
- Dizziness Handicap Inventory (DHI) [Time frame: Weeks 0 and 7]
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Weeks 0 and 7]
- Quality of Life after Brain Injury (QOLIBRI) [Time frame: Weeks 0 and 7]
- Activities-specific Balance Confidence Scale (ABC) [Time frame: Weeks 0 and 7]
- PROMIS - Satisfaction with Participation in Social Roles [Time frame: Weeks 0 and 7]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Weeks 0 and 7]
- Modified Clinical Test of Sensory Integration on Balance (mCTSIB) [Time frame: Weeks 0 and 7]
- Complex Turning Course (CTC) [Time frame: Weeks 0 and 7]
- Complex Uneven Turning Course (CUTC) [Time frame: Weeks 0 and 7]
- 10-Meter Walk Test (10MWT) [Time frame: Weeks 0 and 7]
- Timed Tandem Gait [Time frame: Weeks 0 and 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- OHSU Balance Disorders Laboratory — Portland
- University of Utah Neuromechanics and Applied Locomotion Laboratory — Salt Lake City
Identifiers
NCT: NCT07549529 · IRB#28652 · HT9425-25-1-0748