Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion

Study Overview
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Brief Summary
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Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations. The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

Detailed Description
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To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity. During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.

Official Title
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A Longitudinal Examination of Dynamic Balance Control, Vestibular/Ocular Motor Function, and Activity Participation Following Concussion

Conditions
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Brain Concussion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 12 and 40 years No history of concussion in the past year, and no lifetime history of more than 3 concussions Diagnosed with concussion within the past 21 days (concussion group only) Exclusion Criteria: Lower extremity deficiency or injury, which may affect normal balance or gait History of permanent memory loss Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concussion<br>Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they receive a diagnosis of concussion, defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. If they agree to participate, they will be placed in the concussion group and assessed at each visit to the clinic. No intervention will be administered. | |
| Control<br>Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they come to the clinic for an injury unrelated to brain function or a lower extremity function (which may affect normal gait patterns). If they agree to participate, they will be placed in the control group and assessed at each visit to the clinic. No intervention will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Balance Control | For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal/Distance Gait Measurements | Stride velocity, stride length, gait cycle time, turning duration/velocity, and anticipatory postural adjustments will help to quantify gait stability in different conditions | 1 year | 
| Vestibular-Ocular Motor Screen | The severity of symptom provocation in each condition of the vestibular-ocular motor test | 1 year | 
| Weekly physical and cognitive activity scores | Scores rated by the patient will be calculated across their duration of participation in the study and used to associate the amount of activity participated in with the duration of time to recovery | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Mild Traumatic Brain Injury, Post-Concussion Syndrome, Recovery of Function, Locomotion, Motor Activity