Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury

Study Overview
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Brief Summary
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The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance training on patients with dizziness and balance problems after traumatic brain injury.

Detailed Description
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8 000 to 10 000 persons are admitted to hospitals in Norway with traumatic brain injury (TBI)annually. Dizziness and balance problems have an incidence of 30-80% in this population. Studies show that dizziness and imbalance has the potential to restrict several aspects of personal and social life. Vestibular rehabilitation (VR) is an accepted and effective treatment for dizziness and imbalance. However there is lack of evidence/knowledge about its effect on TBI patients. The study is designed as a randomized controlled trial study (RCT). Patients aged 16-60 admitted to Oslo University Hospital with TBI and symptoms of dizziness and imbalance are included 8 weeks after the injury. The intervention and control group will receive multidisciplinary assessment and evaluation. The intervention group will in addition receive group training and a home exercise program by physiotherapists. The intervention will consist of a individually adapted Vestibular Rehabilitation and balance program. The main outcome measurement is the Dizziness Handicap Inventory (DHI). The study has several other self-report and performance based outcome measures. The outcome measures will be performed before and after the intervention and 6 months after the injury.

Official Title
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Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.

Conditions
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Traumatic Brain Injury, Brain Concussion, Head Injury, Dizziness

Intervention / Treatment
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* Other: Multidisciplinary evaluation and VR
* Other: Multidisciplinary evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TBI patients enrolled at Oslo University Hospital. persistent dizziness and/or balance problems 2 months post-injury. functionally and cognitively able to attend a group training program with vestibular rehabilitation and balance training as the main focus. Exclusion Criteria: severe psychiatric disorder, language problems, cognitive dysfunction that makes self-report difficult, extremity injuries, not being able to walk.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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: Multidisciplinary evaluation and VR<br>Vestibular rehabilitation and balance training. Twice a week for eight weeks.Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury. | Other: Multidisciplinary evaluation and VR<br>* Multidisciplinary assessment and evaluation and VR - Vestibular rehabilitation and balance training. Individually adjusted exercises in groups twice a week for two months. Home exercise program.<br>* Other names: Multidisciplinary evaluation and Vestibular rehabilitation;|
| Active Comparator: Multidisciplinary evaluation and no VR<br>Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury. | Other: Multidisciplinary evaluation<br>* Multidisciplinary assessment and evaluation.<br>* Other names: Multidisciplinary assessment and evaluation.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) | The Dizziness Handicap Inventory (DHI) was developed to measure the self-perceived level of handicap associated with the symptom of dizziness (Jacobson, 1990). The DHI is a 25 item self-report questionnaire with 3 response levels: yes = 4, sometimes = 2, no = 0. The total score is obtained by summing the ordinal scale responses obtained from the 3 response levels (0-100, higher score indicates worse handicap) (Jacobson, 1990). The DHI has been translated into Norwegian and has demonstrated satisfactory measurement properties (Tamber, 2009). | Up to 12 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High level mobility assessment tool for traumatic brain injury (HiMAT) | The HiMAT is a uni-dimensional performance-based measure of balance and mobility. It consists of 13 walking, running, skipping, hopping and stair items that are measured either by a stopwatch or tape-measure. Raw scores measured in times and distances are noted and converted to a score on a 5-point scale from 0-4, except the two dependent stair items that are rated on a 6- point scale from 0-5. A 0 corresponds to inability to perform the item, and 1 -4/5 represents increasing levels of ability. The sum score range is 0-54 (worst-best). A user/instruction manual for the testers describing the test in detail is developed. (Williams, 2006;Williams, 2006). | Up to 12 months post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, Dizziness, Vestibular rehabilitation, Balance rehabilitation