About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Motor Activation Physical Therapy for mTBI
Other interventionThe 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 interventionThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Patient Global Impression of Change (PGIC)
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).
Dizziness Handicap Inventory (DHI)
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.
Neurobehavioral Symptom Inventory (NSI)
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.
Quality of Life after Brain Injury (QOLIBRI)
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
University of Utah
Collaborator
Fort Sam Houston
Collaborator