Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury (VRTBI2012)
Primary Purpose
Traumatic Brain Injury, Brain Concussion, Head Injury
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multidisciplinary evaluation and VR
Multidisciplinary evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, Dizziness, Vestibular rehabilitation, Balance rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multidisciplinary evaluation and VR
Multidisciplinary evaluation and no VR
Arm Description
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.
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01695577
First Posted
September 19, 2012
Last Updated
May 7, 2018
Sponsor
Oslo University Hospital
Collaborators
Oslo University College
1. Study Identification
Unique Protocol Identification Number
NCT01695577
Brief Title
Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury
Acronym
VRTBI2012
Official Title
Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2013 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Oslo University College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Brain Concussion, Head Injury, Dizziness
Keywords
Traumatic brain injury, Dizziness, Vestibular rehabilitation, Balance rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary evaluation and VR
Arm Type
Experimental
Arm Description
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.
Arm Title
Multidisciplinary evaluation and no VR
Arm Type
Active Comparator
Arm Description
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary evaluation and VR
Other Intervention Name(s)
Multidisciplinary evaluation and Vestibular rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary evaluation
Other Intervention Name(s)
Multidisciplinary assessment and evaluation.
Intervention Description
Multidisciplinary assessment and evaluation.
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI)
Description
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).
Time Frame
Up to 12 months post injury
Secondary Outcome Measure Information:
Title
High level mobility assessment tool for traumatic brain injury (HiMAT)
Description
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).
Time Frame
Up to 12 months post injury
Other Pre-specified Outcome Measures:
Title
Balance Error Scoring System (BESS).
Description
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).
Time Frame
Up to 12 months post injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingerid Kleffelgård, MSc.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury
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