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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT07549529
Status
Not Yet Recruiting

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Conditions

  • Concussion, Mild Traumatic Brain Injury
  • Mild Traumatic Brain Injury (mTBI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Motor Activation Physical Therapy for mTBI — OTHER
    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.
  • Standard of Care Physical Therapy for mTBI — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Instrumented, Modified Push & Release Test (I-mP&R) - Time to Stability [ Time Frame: Weeks 0 and 7 of study ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OHSU Balance Disorders LaboratoryPortlandOregon97239
Maggie Stojak, MS
971-420-4351
Laurie King, PhD, PT, MCR
503-418-2602
Laurie King, PhD, PT, MCR (PRINCIPAL_INVESTIGATOR)
University of Utah Neuromechanics and Applied Locomotion LaboratorySalt Lake CityUtah84106
Peter Fino, PhD
(801) 410-0875
Peter Fino, PhD (SUB_INVESTIGATOR)

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