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Vestibular Rehabilitation and Dizziness (DZO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01729039
First received: November 13, 2012
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Dizziness
Behavioral: standard balance rehabilitation
Behavioral: gaze stability
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation and Dizziness in Geriatric Patients

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • symptoms of dizziness [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ] [ Designated as safety issue: No ]
    The subject's perception of dizziness and imbalance during ambulation and during sitting will be assessed using visual analogue scales.


Secondary Outcome Measures:
  • gaze stability [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ] [ Designated as safety issue: No ]
    visual acuity during head movements

  • fall risk [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ] [ Designated as safety issue: No ]
    fall risk is determined by dynamic gait index

  • Activities-specific balance confidence (ABC) [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ] [ Designated as safety issue: No ]
    The ABC was developed to measure the subject's confidence with their balance across a continuum of activities.

  • Gait speed [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ] [ Designated as safety issue: No ]
    Subjects are asked to walk at their preferred gait speed. The time it takes to walk 20 feet is recorded using a calibrated stopwatch and gait speed is calculated.


Estimated Enrollment: 97
Study Start Date: November 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gaze stability
standard balance rehabilitation plus vestibular-specific exercises
Behavioral: 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.
Behavioral: 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: control
standard balance rehabilitation plus placebo eye exercises
Behavioral: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729039

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Tennessee
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, United States, 37684
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Courtney D Hall, PhD PT Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01729039     History of Changes
Other Study ID Numbers: E7613-R 
Study First Received: November 13, 2012
Last Updated: September 13, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
rehabilitation
aged
aged, 80 and over
vestibular diseases

Additional relevant MeSH terms:
Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016