Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury (VRTBI2012)
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| ClinicalTrials.gov Identifier: NCT01695577 |
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Recruitment Status :
Completed
First Posted : September 28, 2012
Last Update Posted : May 8, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Traumatic Brain Injury Brain Concussion Head Injury Dizziness | Other: Multidisciplinary evaluation and VR Other: Multidisciplinary evaluation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury. |
| Actual Study Start Date : | January 15, 2013 |
| Actual Primary Completion Date : | August 30, 2016 |
| Actual Study Completion Date : | August 30, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Multidisciplinary evaluation and VR
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.
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Other: Multidisciplinary evaluation and VR
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.
Other Name: Multidisciplinary evaluation and Vestibular rehabilitation |
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Active Comparator: Multidisciplinary evaluation and no VR
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
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Other: Multidisciplinary evaluation
Multidisciplinary assessment and evaluation.
Other Name: Multidisciplinary assessment and evaluation. |
- Dizziness Handicap Inventory (DHI) [ Time Frame: Up to 12 months post injury ]
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).
- High level mobility assessment tool for traumatic brain injury (HiMAT) [ Time Frame: Up to 12 months post injury ]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).
- Balance Error Scoring System (BESS). [ Time Frame: Up to 12 months post injury ]The Bess is a standardized balance testing system. It consists of three 20 second, standardized stances on a firm surface and on a foam surface with eyes closed. The stances are: double leg stance, single-leg stance and tandem stance. Errors are counted during each 20-second trial(Bell, 2011;Finnoff, 2009). The Bess has variable but satisfactory measurement properties and norms are developed (Bell, 2011).
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| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695577
| Norway | |
| Oslo University Hospital | |
| Oslo, Norway, 0424 | |
| Principal Investigator: | Ingerid Kleffelgård, MSc. | Oslo University Hospital |
| Responsible Party: | Ingerid Kleffelgård, Physical Therapist/ PhD student, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01695577 History of Changes |
| Other Study ID Numbers: |
OUSHIOA2012 2012/195b ( Other Identifier: REK ) 2012/1623 ( Other Identifier: Personvernombudet OUS ) |
| First Posted: | September 28, 2012 Key Record Dates |
| Last Update Posted: | May 8, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Ingerid Kleffelgård, Oslo University Hospital:
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Traumatic brain injury Dizziness Vestibular rehabilitation Balance rehabilitation |
Additional relevant MeSH terms:
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Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Craniocerebral Trauma Dizziness Vertigo Brain Concussion Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Sensation Disorders Neurologic Manifestations Signs and Symptoms Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Head Injuries, Closed Wounds, Nonpenetrating |