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Vestibular Rehabilitation and Dizziness (DZO)

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ClinicalTrials.gov Identifier: NCT01729039
Recruitment Status : Active, not recruiting
First Posted : November 20, 2012
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

November 13, 2012
November 20, 2012
February 23, 2017
November 1, 2012
September 30, 2016   (Final data collection date for primary outcome measure)
symptoms of dizziness [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
The subject's perception of dizziness and imbalance during ambulation and during sitting will be assessed using visual analogue scales.
symptoms of dizziness [ Time Frame: up to 6 months ]
The subject's perception of dizziness and imbalance during ambulation and during sitting will be assessed using visual analogue scales.
Complete list of historical versions of study NCT01729039 on ClinicalTrials.gov Archive Site
  • gaze stability [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
    visual acuity during head movements
  • fall risk [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
    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 ]
    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 ]
    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.
  • gaze stability [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
    visual acuity during head movements
  • fall risk [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
    fall risk is determined by dynamic gait index
  • Activities-specific balance confidence [ Time Frame: baseline, discharge from PT, 1 and 6 months post-PT ]
    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 ]
    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.
Not Provided
Not Provided
 
Vestibular Rehabilitation and Dizziness
Vestibular Rehabilitation and Dizziness in Geriatric Patients
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Dizziness
  • 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.
  • 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.
  • Experimental: gaze stability
    standard balance rehabilitation plus vestibular-specific exercises
    Interventions:
    • Behavioral: standard balance rehabilitation
    • Behavioral: gaze stability
  • Placebo Comparator: control
    standard balance rehabilitation plus placebo eye exercises
    Interventions:
    • Behavioral: standard balance rehabilitation
    • Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
97
Same as current
April 2017
September 30, 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01729039
E7613-R
No
Not Provided
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Courtney D Hall, PhD PT Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
VA Office of Research and Development
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP