Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury

NCT ID: NCT01695577

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-15
• Study Completion Date: 2016-08-30

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.

Conditions

Traumatic Brain Injury; Brain Concussion; Head Injury; Dizziness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multidisciplinary evaluation and VR

Intervention Type: OTHER

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.

Multidisciplinary evaluation and no VR

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

Group Type: ACTIVE_COMPARATOR

Multidisciplinary evaluation

Intervention Type: OTHER

Multidisciplinary assessment and evaluation.

Interventions

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.

Intervention Type: OTHER

Multidisciplinary evaluation

Multidisciplinary assessment and evaluation.

Intervention Type: OTHER

Other Intervention Names

Multidisciplinary evaluation and Vestibular rehabilitation; Multidisciplinary assessment and evaluation.

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University College

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingerid Kleffelgård

Physical Therapist/ PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingerid Kleffelgård, MSc.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2012/195b

Identifier Type: OTHER

Identifier Source: secondary_id

2012/1623

Identifier Type: OTHER

Identifier Source: secondary_id

OUSHIOA2012

Identifier Type: -

Identifier Source: org_study_id