Traumatic Brain InjuryVRTBI2012NCT01695577
Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury
A study testing Multidisciplinary evaluation and VR and Multidisciplinary evaluation in people with Traumatic Brain Injury and Brain Concussion, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Brain Concussion, Head Injury
- What is being tested?
- Multidisciplinary evaluation and VR and Multidisciplinary evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2013to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- severe psychiatric disorder,
- language problems,
- cognitive dysfunction that makes self-report difficult,
- extremity injuries,
- not being able to walk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Brain Concussion, Head Injury, Dizziness
- Being tested
- Multidisciplinary evaluation and VR, Multidisciplinary evaluation
- Keywords
- Traumatic brain injury, Dizziness, Vestibular rehabilitation, Balance rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Craniocerebral Trauma, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary evaluation and VROther
Also called Multidisciplinary evaluation and Vestibular rehabilitation
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.
Multidisciplinary evaluationOther
Also called Multidisciplinary assessment and evaluation.
Multidisciplinary assessment and evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary evaluation and VR | Experimental | 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. Receives: Other: Multidisciplinary evaluation and VR |
| Multidisciplinary evaluation and no VR | Active comparator | Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury. Receives: Other: Multidisciplinary evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months post injury
Secondary outcomes (1)
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).
Measured: Up to 12 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study start15 Jan 2013
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University College
- Responsible party
- Principal investigator, Ingerid Kleffelgård, Oslo University Hospital
- Investigators
- Ingerid Kleffelgård, MSc., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695577
- Sponsor's protocol ID
- OUSHIOA2012
- Other IDs
- 2012/195b, 2012/1623
- Acronym
- VRTBI2012
- Status last verified
- May 2018
- First submitted
- 19 Sep 2012
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT01695577
- Acronym / sponsor ID
- VRTBI2012 / OUSHIOA2012
- Conditions
- Traumatic Brain Injury, Brain Concussion, Head Injury, Dizziness
- Keywords
- Traumatic brain injury, Dizziness, Vestibular rehabilitation, Balance rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Oslo University College
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary evaluation and VR | Experimental | Other: Multidisciplinary evaluation and VRVestibular 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 and no VR | Active comparator | Other: Multidisciplinary evaluationMultidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- severe psychiatric disorder,
- language problems,
- cognitive dysfunction that makes self-report difficult,
- extremity injuries,
- not being able to walk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary evaluation and VRAlso: Multidisciplinary evaluation and Vestibular rehabilitationMultidisciplinary 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 | Multidisciplinary evaluation and VR |
| Multidisciplinary evaluationAlso: Multidisciplinary assessment and evaluation.Multidisciplinary assessment and evaluation. | Other | Multidisciplinary evaluation and no VR |
Primary outcome
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).
1 secondary outcome
High level mobility assessment tool for traumatic brain injury (HiMAT)
Time frame: Up to 12 months post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingerid Kleffelgård, MSc. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary evaluation and VR and Multidisciplinary evaluation in people with Traumatic Brain Injury and Brain Concussion, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: Up to 12 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.