Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Dizziness; Brain Concussion; Head Injury; Traumatic Brain Injury
• Interventions: Other: Multidisciplinary evaluation; Other: Multidisciplinary evaluation and VR

• Registration Number: NCT01695577
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-28
• Study Start: 2013-01-15
• Primary Completion: 2016-08-30
• Study Completion: 2016-08-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidisciplinary evaluation and no VR	Multidisciplinary evaluation	Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
Multidisciplinary evaluation and VR	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.

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI)	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).

Secondary Outcome Measures

Name	Time	Method
High level mobility assessment tool for traumatic brain injury (HiMAT)	Up to 12 months post injury	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).

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway