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

NCT07549529 | Not Yet Recruiting

• 2 other identifiers: IRB#28652HT9425-25-1-0748
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

mTBI; concussion; motor activation; reaction time; physical therapy; vestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 0 and 7 of study

Secondary Outcomes (30)

• Patient Global Impression of Change (PGIC)

  Week 7 only

• Dizziness Handicap Inventory (DHI)

  Weeks 0 and 7

• Neurobehavioral Symptom Inventory (NSI)

  Weeks 0 and 7

• Quality of Life after Brain Injury (QOLIBRI)

  Weeks 0 and 7

• Activities-specific Balance Confidence Scale (ABC)

  Weeks 0 and 7

Study Arms (2)

Participants with motor physical therapy for mTBI

EXPERIMENTAL

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

Standard of care physical therapy treatment for mTBI

ACTIVE COMPARATOR

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

Interventions

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.

Standard of care physical therapy treatment for mTBI

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.

Participants with motor physical therapy for mTBI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed mTBI (concussion)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Utah: collaborator
• Fort Sam Houston: collaborator

Study Sites (2)

OHSU Balance Disorders Laboratory

Portland, Oregon, 97239, United States

Location

University of Utah Neuromechanics and Applied Locomotion Laboratory

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Laurie A King, PhD, PT, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Peter Fino, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie E Stojak, MS

CONTACT

971-420-4351; concussionresearch@ohsu.edu

Laurie A King, PhD

CONTACT

503-418-2602; kingla@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person performing the statistical analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (2)