Vestibular Rehabilitation and Dizziness

NCT ID: NCT01729039

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-01
• Study Completion Date: 2017-02-28

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.

Conditions

Dizziness

Study Design

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

Study Groups

gaze stability

standard balance rehabilitation plus vestibular-specific exercises

Group Type: EXPERIMENTAL

standard balance rehabilitation

Intervention Type: BEHAVIORAL

All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.

gaze stability

Intervention Type: BEHAVIORAL

Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.

control

standard balance rehabilitation plus placebo eye exercises

Group Type: PLACEBO_COMPARATOR

standard balance rehabilitation

Intervention Type: BEHAVIORAL

All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.

Control

Intervention Type: BEHAVIORAL

The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.

Interventions

standard balance rehabilitation

All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.

Intervention Type: BEHAVIORAL

gaze stability

Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.

Intervention Type: BEHAVIORAL

Control

The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtney D Hall, PhD PT

Role: PRINCIPAL_INVESTIGATOR

Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Mountain Home, Tennessee, United States

Countries

United States

Other Identifiers

E7613-R

Identifier Type: -

Identifier Source: org_study_id