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

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.

Study Overview

• Status: Completed
• Conditions: Dizziness; Traumatic Brain Injury; Brain Concussion; Head Injury
• Intervention / Treatment: Other: Multidisciplinary evaluation and VR; Other: Multidisciplinary evaluation

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multidisciplinary evaluation and VR; 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.	Other: Multidisciplinary evaluation and VR; 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.; Other Names: Multidisciplinary evaluation and Vestibular rehabilitation
ACTIVE_COMPARATOR: Multidisciplinary evaluation and no VR; Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.	Other: Multidisciplinary evaluation; Multidisciplinary assessment and evaluation.; Other Names: Multidisciplinary assessment and evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 months post injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 months post injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Error Scoring System (BESS).	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).	Up to 12 months post injury

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Oslo University College
• Investigators: Principal Investigator: Ingerid Kleffelgård, MSc., Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2013
• Primary Completion (ACTUAL): August 30, 2016
• Study Completion (ACTUAL): August 30, 2016

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (ESTIMATE): September 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Dizziness; Vestibular rehabilitation; Balance rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Trauma, Nervous System; Vestibular Diseases; Sensation Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Vertigo; Dizziness; Craniocerebral Trauma; Brain Concussion
• Other Study ID Numbers: OUSHIOA2012; 2012/195b (OTHER: REK); 2012/1623 (OTHER: Personvernombudet OUS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED