Completed

VRTBI2012Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.

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What is being tested

Multidisciplinary evaluation and VR

+ Multidisciplinary evaluation

Other
Who is being recruted

Brain Diseases+13

+ Brain Injuries

+ Central Nervous System Diseases

From 16 to 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorOslo University Hospital
Last updated: May 8, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2013

Actual date on which the first participant was enrolled.

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.

NCT01695577
Principal SponsorOslo University Hospital
Last updated: May 8, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

65 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain InjuriesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesWounds, NonpenetratingHead Injuries, ClosedTrauma, Nervous SystemBrain Injuries, TraumaticBrain ConcussionDizzinessCraniocerebral Trauma

Criteria

3 inclusion criteria required to participate
TBI patients enrolled at Oslo University Hospital
functionally and cognitively able to attend a group training program with vestibular rehabilitation and balance training as the main focus
persistent dizziness and/or balance problems 2 months post-injury
5 exclusion criteria prevent from participating
cognitive dysfunction that makes self-report difficult
extremity injuries
language problems
not being able to walk
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Oslo University Hospital

Oslo, NorwayOpen Oslo University Hospital in Google Maps
CompletedOne Study Center