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Vestibular Rehabilitation and Dizziness in Geriatric Patients

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ClinicalTrials.gov Identifier: NCT00275392
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : October 17, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dizziness
Interventions Behavioral: Vestibular rehabilitation
Behavioral: Placebo
Enrollment 39

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vestibular Rehabilitation Placebo
Hide Arm/Group Description

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

Period Title: Overall Study
Started 20 19
Completed 20 17
Not Completed 0 2
Arm/Group Title Vestibular Rehabilitation Placebo Total
Hide Arm/Group Description

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

Total of all reporting groups
Overall Number of Baseline Participants 20 17 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 17 participants 37 participants
73.6  (6.5) 74.5  (8.5) 73.8  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 37 participants
Female
17
  85.0%
11
  64.7%
28
  75.7%
Male
3
  15.0%
6
  35.3%
9
  24.3%
Dynamic Gait Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 17 participants 37 participants
14.2  (3.1) 16.1  (2.6) 15.1  (3.0)
[1]
Measure Description: 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.
Dynamic Visual Acuity   [1] 
Mean (Standard Deviation)
Unit of measure:  LogMAR
Number Analyzed 20 participants 17 participants 37 participants
0.20  (0.08) 0.14  (0.07) 0.16  (0.08)
[1]
Measure Description: 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).
1.Primary Outcome
Title Dynamic Gait Index
Hide Description Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analyses (i.e., only subjects who completed the intervention were included).
Arm/Group Title Vestibular Rehabilitation Placebo
Hide Arm/Group Description:

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Discharge (6 weeks) 18.9  (1.8) 18.9  (3.0)
Baseline 14.2  (3.1) 16.1  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vestibular Rehabilitation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments Interaction effect
Method RM ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vestibular Rehabilitation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments main effect of time
Method RM ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vestibular Rehabilitation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments main effect of group
Method RM ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Dynamic Visual Acuity
Hide Description Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vestibular Rehabilitation Placebo
Hide Arm/Group Description:

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: LogMAR
Discharge (6 weeks) 0.14  (0.07) 0.19  (0.08)
Baseline 0.20  (0.08) 0.21  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vestibular Rehabilitation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.05
Comments Interaction effect
Method RM ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vestibular Rehabilitation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .016
Comments main effect of time
Method RM ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments Main effect of Group
Method RM ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vestibular Rehabilitation Placebo
Hide Arm/Group Description

vestibular exercises plus standard balance and gait exercises

Vestibular rehabilitation: vestibular adaptation and substitution exercises

placebo exercises plus standard balance and gait exercises

Placebo Vestibular rehabilitation: placebo vestibular exercises

All-Cause Mortality
Vestibular Rehabilitation Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vestibular Rehabilitation Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vestibular Rehabilitation Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00275392     History of Changes
Other Study ID Numbers: C4168-P
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: September 17, 2014
Results First Posted: October 17, 2014
Last Update Posted: December 9, 2014