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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Oslo University Hospital
Sponsor:
Collaborator:
Oslo University College
Information provided by (Responsible Party):
Ingerid Kleffelgård, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01695577
First received: September 19, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Brain Concussion
Head Injury
Dizziness
Other: Multidisciplinary evaluation and VR
Other: Multidisciplinary evaluation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Dizziness Handicap Inventory (DHI) [ Time Frame: Up to 6 months post injury ] [ Designated as safety issue: No ]

    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:
  • High level mobility assessment tool for traumatic brain injury (HiMAT) [ Time Frame: Up to 6 months post injury ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Balance Error Scoring System (BESS)on a force plate. [ Time Frame: Up to 6 months post injury ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Multidisciplinary assessment and 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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695577

Contacts
Contact: Ingerid Kleffelgard, MSc +4799010874 uxinff@ous-hf.no
Contact: Helene Lundgaard Soberg, PhD h.l.soberg@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Ingerid Kleffelgård, MSc.    +47 99010874      
Principal Investigator: Ingerid Kleffelgård, MSc.         
Sponsors and Collaborators
Oslo University Hospital
Oslo University College
Investigators
Principal Investigator: Ingerid Kleffelgård, MSc. Oslo University Hospital
  More Information

No publications provided

Responsible Party: Ingerid Kleffelgård, Physical Therapist/ PhD student, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01695577     History of Changes
Other Study ID Numbers: OUSHIOA2012, 2012/195b, 2012/1623
Study First Received: September 19, 2012
Last Updated: October 17, 2013
Health Authority: Norway: Regional Ethics Commitee
Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
Traumatic brain injury
Dizziness
Vestibular rehabilitation
Balance rehabilitation

Additional relevant MeSH terms:
Brain Concussion
Dizziness
Vertigo
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014