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Clinical Trials/NCT01729039
NCT01729039CompletedNot Applicable

Vestibular Rehabilitation and Dizziness in Geriatric Patients

VA Office of Research and Development2 sites in 1 country49 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
49
Locations
2
Primary Endpoint
Visual Analog Scale - Head Movement

Study Overview

Brief Summary

The purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.

Detailed Description

Dizziness is among the most prevalent complaints for which people seek medical help and the incidence increases with advancing age. Dizziness represents a diagnostic and treatment challenge because it is a subjective sensation, refers to a variety of symptoms (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential contributory factors. Dizziness is often related to vestibular disease which is treated effectively with vestibular exercises. Successful management of dizziness is critical because dizziness is a major risk factor for falls in older adults.

There are parallels between the effects of age-related versus disease-related loss of vestibular function - in complaints of dizziness and increased risk for falls. The investigators' question, then, is whether the same exercises that are beneficial for patients with vestibular pathology are beneficial for older patients with dizziness but normal vestibular function.

Older adults with dizziness who have been referred to Audiology for vestibular evaluation will be randomized to receive either standard balance rehabilitation plus placebo eye exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS). Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity, postural stability as measured by sensory organization test, fall risk as measured by dynamic gait index, and gait speed. Assessment will occur at baseline, discharge from physical therapy (PT), 1 and 6 months post-PT.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •at least 50 years of age
  • •documented balance or mobility problems
  • •normal vestibular function, including otolith function

Exclusion Criteria

  • •cognitive impairment
  • •progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy)
  • •dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV)

Arms & Interventions

gaze stability

Experimental

standard balance rehabilitation plus vestibular-specific exercises

Intervention: standard balance rehabilitation (Behavioral)

gaze stability

Experimental

standard balance rehabilitation plus vestibular-specific exercises

Intervention: gaze stability (Behavioral)

control

Placebo Comparator

standard balance rehabilitation plus placebo eye exercises

Intervention: standard balance rehabilitation (Behavioral)

control

Placebo Comparator

standard balance rehabilitation plus placebo eye exercises

Intervention: Control (Behavioral)

Outcomes

Primary Outcomes

Visual Analog Scale - Head Movement

Time Frame: 6 weeks

This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.

Visual Analog Scale - Disequilibrium

Time Frame: 6 weeks

This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.

Secondary Outcomes

  • Dynamic Gait Index(6 weeks)
  • Activities-specific Balance Confidence Scale(6 weeks)
  • 10 Meter Walk Test(6 weeks)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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