Overview

This trial is active, not recruiting.

Condition dizziness
Treatments standard balance rehabilitation, gaze stability, control
Sponsor VA Office of Research and Development
Start date November 2012
End date September 2016
Trial size 97 participants
Trial identifier NCT01729039, E7613-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
standard balance rehabilitation plus vestibular-specific exercises
standard balance rehabilitation
All subjects will perform balance and gait exercises in addition to the eye movement exercises and will be provided a written home exercise program (HEP) consisting of balance and gait exercises designed to improve postural stability and mobility with progressively more challenging tasks. Balance exercises will include maintaining stability in standing with vision and somatosensory cues altered, dynamic weight shifting and performing ankle, hip and step strategies. Gait activities will include negotiating uneven terrains and obstacles, gait with slow head turns focusing on objects, varied speed (speeding up and slowing down), and unpredictable starts and stops. Walking for endurance will be included in the HEP. Each participant will receive a customized balance and gait HEP based on identified impairments and will be progressed according to ability and level of assistance at home as is standard in PT.
gaze stability
Vestibular adaptation and substitution exercises were designed originally based on the error signals (retinal slip) that induce changes in gain in the vestibular system and 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. Substitution exercises specifically attempt to facilitate use of alternative strategies, rather than teaching the specific strategies. 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.
(Placebo Comparator)
standard balance rehabilitation plus placebo eye exercises
standard balance rehabilitation
All subjects will perform balance and gait exercises in addition to the eye movement exercises and will be provided a written home exercise program (HEP) consisting of balance and gait exercises designed to improve postural stability and mobility with progressively more challenging tasks. Balance exercises will include maintaining stability in standing with vision and somatosensory cues altered, dynamic weight shifting and performing ankle, hip and step strategies. Gait activities will include negotiating uneven terrains and obstacles, gait with slow head turns focusing on objects, varied speed (speeding up and slowing down), and unpredictable starts and stops. Walking for endurance will be included in the HEP. Each participant will receive a customized balance and gait HEP based on identified impairments and will be progressed according to ability and level of assistance at home as is standard in PT.
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.

Primary Outcomes

Measure
symptoms of dizziness
time frame: baseline, discharge from PT, 1 and 6 months post-PT

Secondary Outcomes

Measure
gaze stability
time frame: baseline, discharge from PT, 1 and 6 months post-PT
fall risk
time frame: baseline, discharge from PT, 1 and 6 months post-PT
Activities-specific balance confidence (ABC)
time frame: baseline, discharge from PT, 1 and 6 months post-PT
Gait speed
time frame: baseline, discharge from PT, 1 and 6 months post-PT

Eligibility Criteria

Male or female participants at least 50 years old.

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)

Additional Information

Official title Vestibular Rehabilitation and Dizziness in Geriatric Patients
Principal investigator Courtney D Hall, PhD PT
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.