Stationary Bike Study

Study Overview
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Brief Summary
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Investigators will use a stationary bike protocol to investigate whether patients with post concussion syndrome benefit from adding exertion training to a vestibular rehabilitation program. Investigators examine the effect of aerobic exercise testing and training on individuals with concussion who are currently experiencing symptoms and examine the effect of aerobic exercise in combination with traditional vestibular rehabilitation.

Detailed Description
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This is a randomized controlled single blind pilot study testing the hypothesis that the combination of aerobic exercise plus vestibular rehabilitation will result in greater reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.

Official Title
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The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion

Conditions
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Vertigo, Concussion, Dizziness

Intervention / Treatment
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* Other: Vestibular Rehabilitation + Aerobic Exercise
* Other: Vestibular Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of concussion >14 days, <6 months One or more of the following symptoms after most recent head injury: headache, dizziness, fatigue, irritability, insomnia, concentration or memory difficulty) Age range - 18-70 Access to stationary bicycle Ability to read and write sixth grade English Exclusion Criteria: Inability to participate in aerobic exercise for any reason Pre-existing or current neurological or autonomic disease including persistent symptoms form previous concussion Major depressive disorder Litigation Increased cardiac risk Currently taking, Beta Blockers, or Anticonvulsants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular Rehabilitation + Areobic Exercise<br> | Other: Vestibular Rehabilitation + Aerobic Exercise<br>* Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.<br>|
| Active Comparator: Vestibular Rehabilitation<br> | Other: Vestibular Rehabilitation<br>* The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual Analog Scale (VAS) of Dizziness Score |  | change in VAS of Dizziness Score from initial evaluation to week 6 | 
| Changes in Dizziness Handicap Inventory (DHI) Score | 25-item scale that addresses the functional, emotional, and physical components of dizziness. Higher scores indicate greater handicap (range, 0 - 100) | change in DHI Score from initial evaluation to week 6 | 
| Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool |  | change in symptoms from initial evaluation to week 6 | 
| Changes in balance Error Scoring System (BESS) score | requires participants to maintain balance with eyes closed with their hands on their iliac crests under six different surface conditions. Number of errors in each trial are added together to obtain a total score (out of 60). | change in (BESS) Score from initial evaluation to week 6 | 
| Changes in Dynamic Visual Acuity (DVA) Score | instrumented, objective assessment of vestibulo-ocular reflex (VOR) function in response to head movement. The Dynamic Visual Acuity Test assesses visual acuity during head movement relative to baseline static visual acuity | change in DVA Score from initial evaluation to week 6 | 
| Changes in Sport Concussion Assessment Tool (SCAT-3) Score | 22 item postconcussion symptom scale using a seven point Likert rating. This scale provides an assessment of symptoms endorsed, along with a severity score. The maximum symptom score is 22, the symptom severity score is obtained by summing the rated symptom score for each symptom (maximum score 132). | change in (SCAT-3) from initial evaluation to week 6 | 
| Functional Gait Assessment | 10-item test that measures gait with a narrow base of support, gait with eyes closed, ambulating backwards, as well as ambulation with head turns. The maximum score is 30. Higher scores indicate better performance. | change in gait from initial evaluation to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular, Rehabilitation