Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury (VRTBI2012)

University of Oslo (UIO)

Status: Completed

Conditions: Head Injury; Traumatic Brain Injury; Dizziness; Brain Concussion

Treatments: Other: Multidisciplinary evaluation; Other: Multidisciplinary evaluation and VR

Study type: Interventional

Funder types: Other

Identifiers

NCT01695577

OUSHIOA2012

2012/195b (Other Identifier)

2012/1623 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Multidisciplinary evaluation and VR

Experimental group

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.

Treatment:

Other: Multidisciplinary evaluation and VR

Multidisciplinary evaluation and no VR

Active Comparator group

Description:

Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.

Treatment:

Other: Multidisciplinary evaluation