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Clinical Trials/NCT01695577
NCT01695577
Completed
N/A

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

Oslo University Hospital1 site in 1 country65 target enrollmentJanuary 15, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Oslo University Hospital
Enrollment
65
Locations
1
Primary Endpoint
Dizziness Handicap Inventory (DHI)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2013
End Date
August 30, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ingerid Kleffelgård

Physical Therapist/ PhD student

Oslo University Hospital

Eligibility 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.

Outcomes

Primary Outcomes

Dizziness Handicap Inventory (DHI)

Time Frame: 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 Outcomes

  • High level mobility assessment tool for traumatic brain injury (HiMAT)(Up to 12 months post injury)

Study Sites (1)

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