Vestibular Rehabilitation and Dizziness in Geriatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00275392
First received: January 10, 2006
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: September 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Dizziness
Interventions: Behavioral: Vestibular rehabilitation
Behavioral: Placebo Vestibular rehabilitation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vestibular Rehabilitation

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

Placebo

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises


Participant Flow:   Overall Study
    Vestibular Rehabilitation     Placebo  
STARTED     20     19  
COMPLETED     20     17  
NOT COMPLETED     0     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vestibular Rehabilitation

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

Placebo

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

Total Total of all reporting groups

Baseline Measures
    Vestibular Rehabilitation     Placebo     Total  
Number of Participants  
[units: participants]
  20     17     37  
Age  
[units: years]
Mean ± Standard Deviation
  73.6  ± 6.5     74.5  ± 8.5     73.8  ± 7.5  
Gender  
[units: participants]
     
Female     17     11     28  
Male     3     6     9  
Study-Specific Measure [1]
[units: units on a scale]
Mean ± Standard Deviation
  14.2  ± 3.1     16.1  ± 2.6     15.1  ± 3.0  
Study-Specific Measure [2]
[units: LogMAR]
Mean ± Standard Deviation
  0.20  ± 0.08     0.14  ± 0.07     0.16  ± 0.08  
[1] The Dynamic Gait Index (DGI) measures the ability to adapt gait to external demands and also is used to assess fall risk while walking. The eight items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate risk for falling.
[2] Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity (0.00 LogMAR = 20/20).



  Outcome Measures
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1.  Primary:   Dynamic Gait Index   [ Time Frame: 6 weeks ]

2.  Secondary:   Dynamic Visual Acuity   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Courtney D. Hall, PhD
Organization: James H. Quillen VAMC
phone: 423-926-1171 ext 7518
e-mail: courtney.hall@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00275392     History of Changes
Other Study ID Numbers: C4168-P
Study First Received: January 10, 2006
Results First Received: September 17, 2014
Last Updated: October 9, 2014
Health Authority: United States: Federal Government