NCT01695577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

3.6 years

First QC Date

September 19, 2012

Last Update Submit

May 7, 2018

Conditions

Traumatic Brain InjuryBrain ConcussionHead InjuryDizziness

Keywords

Traumatic brain injuryDizzinessVestibular rehabilitationBalance rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Dizziness Handicap Inventory (DHI)

    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).

    Up to 12 months post injury

Secondary Outcomes (1)

  • High level mobility assessment tool for traumatic brain injury (HiMAT)

    Up to 12 months post injury

Other Outcomes (1)

  • Balance Error Scoring System (BESS).

    Up to 12 months post injury

Study Arms (2)

Multidisciplinary evaluation and VR

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.

Other: Multidisciplinary evaluation and VR

Multidisciplinary evaluation and no VR

ACTIVE COMPARATOR

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

Other: Multidisciplinary evaluation

Interventions

Multidisciplinary evaluation and VROTHER

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.

Also known as: Multidisciplinary evaluation and Vestibular rehabilitation
Multidisciplinary evaluation and VR
Multidisciplinary evaluationOTHER

Multidisciplinary assessment and evaluation.

Also known as: Multidisciplinary assessment and evaluation.
Multidisciplinary evaluation and no VR

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • severe psychiatric disorder,
  • language problems,
  • cognitive dysfunction that makes self-report difficult,
  • extremity injuries,
  • not being able to walk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain ConcussionCraniocerebral TraumaDizziness

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, NonpenetratingSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ingerid Kleffelgård, MSc.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist/ PhD student

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 28, 2012

Study Start

January 15, 2013

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

NO(1)