Clinical trial NCT01695577: Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury
Official title: Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Brain Concussion
Head Injury
Dizziness
Keywords: Traumatic brain injury
Dizziness
Vestibular rehabilitation
Balance rehabilitation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University College
First posted: 2012-09-28
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Up to 12 months post injury
Secondary outcomes:
measure: High level mobility assessment tool for traumatic brain injury (HiMAT)
timeFrame: Up to 12 months post injury
Other outcomes:
measure: Balance Error Scoring System (BESS).
timeFrame: Up to 12 months post injury
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Ingerid Kleffelgård, MSc.
role: PRINCIPAL_INVESTIGATOR
References: