Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury (VRTBI2012)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Brain Concussion Head Injury Dizziness |
Other: Multidisciplinary evaluation and VR Other: Multidisciplinary evaluation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury. |
- Dizziness Handicap Inventory (DHI) [ Time Frame: Up to 12 months post injury ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
Active Comparator: Multidisciplinary evaluation and no VR
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
|
Other: Multidisciplinary evaluation
Multidisciplinary assessment and evaluation.
Other Name: Multidisciplinary assessment and evaluation.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01695577
| Contact: Ingerid Kleffelgard, MSc | +4799010874 | uxinff@ous-hf.no | |
| Contact: Helene Lundgaard Soberg, PhD | h.l.soberg@medisin.uio.no |
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway, 0424 | |
| Contact: Ingerid Kleffelgård, MSc. +47 99010874 | |
| Principal Investigator: Ingerid Kleffelgård, MSc. | |
| Principal Investigator: | Ingerid Kleffelgård, MSc. | Oslo University Hospital |
More Information
No publications provided
| 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, 2012/1623 |
| Study First Received: | September 19, 2012 |
| Last Updated: | October 16, 2014 |
| Health Authority: | Norway: Regional Ethics Commitee Norway: Data Protection Authority |
Keywords provided by Oslo University Hospital:
|
Traumatic brain injury Dizziness Vestibular rehabilitation Balance rehabilitation |
Additional relevant MeSH terms:
|
Dizziness Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases |
Neurologic Manifestations Sensation Disorders Signs and Symptoms Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on March 03, 2015