Overview

This trial is active, not recruiting.

Conditions traumatic brain injury, brain concussion, head injury, dizziness
Treatments multidisciplinary evaluation and vr, multidisciplinary evaluation
Sponsor Oslo University Hospital
Collaborator Oslo University College
Start date September 2012
End date December 2016
Trial size 65 participants
Trial identifier NCT01695577, 2012/1623, 2012/195b, OUSHIOA2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
multidisciplinary evaluation and vr 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.
(Active Comparator)
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
multidisciplinary evaluation Multidisciplinary assessment and evaluation.
Multidisciplinary assessment and evaluation.

Primary Outcomes

Measure
Dizziness Handicap Inventory (DHI)
time frame: Up to 12 months post injury

Secondary Outcomes

Measure
High level mobility assessment tool for traumatic brain injury (HiMAT)
time frame: Up to 12 months post injury

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

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.

Additional Information

Official title Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
Principal investigator Ingerid Kleffelgård, MSc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.