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Recovery of Visual Acuity in People With Vestibular Deficits

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ClinicalTrials.gov Identifier: NCT00411216
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : July 21, 2014
Last Update Posted : August 7, 2015
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Susan Herdman, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Vestibular Neuronitis
Vestibular Neuronitis, Bilateral
Vestibular Schwannoma
Interventions Other: Control exercises
Other: gaze stabilization exercises
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exercises for Gaze Stabilization Control Exercises
Hide Arm/Group Description

Experimental group performed vestibular adaptation and substitution exercises

gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements

Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements

Control exercises: saccadic eye movements against a plain background; no head movements

Period Title: Overall Study
Started 13 10
Completed 13 8
Not Completed 0 2
Reason Not Completed
Ten participants were entered into the c             0             2
Arm/Group Title Exercises for Gaze Stabilization Control Exercises Total
Hide Arm/Group Description Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
65.2  (16.5) 64.9  (16.2) 65.1  (16.3)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  46.2%
5
  50.0%
11
  47.8%
>=65 years
7
  53.8%
5
  50.0%
12
  52.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
9
  69.2%
6
  60.0%
15
  65.2%
Male
4
  30.8%
4
  40.0%
8
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 10 participants 23 participants
13 10 23
Visual acuity during head movements  
Mean (Standard Deviation)
Unit of measure:  LogMAR
Number Analyzed 13 participants 10 participants 23 participants
.372  (.155) .323  (.117) .348  (.136)
1.Primary Outcome
Title Change in Visual Acuity During Head Movement From Baseline to Discharge
Hide Description

visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.

The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention).

Time Frame pre-intervention and at discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercises for Gaze Stabilization Control Exercises
Hide Arm/Group Description:

Experimental group performed vestibular adaptation and substitution exercises

gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements

Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements

Control exercises: saccadic eye movements against a plain background; no head movements

Overall Number of Participants Analyzed 13 8
Mean (Standard Deviation)
Unit of Measure: LogMAR
0.198  (0.101) .296  (.122)
2.Primary Outcome
Title Subjective Complaints: (All Pre- and Post-intervention):
Hide Description questionnaire
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Disability Scale
Hide Description questionnaire
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Activities Specific Balance Confidence Scale
Hide Description questionnaire
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
Hide Description visual analoque scales
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Balance and Gait
Hide Description gait speed
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Fall Risk (Dynamic Gait Index)
Hide Description performance test
Time Frame pre-intervention, 2 weeks, 4 weeks and at discharge
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Eye Movements: Scleral Search Coil
Hide Description eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field
Time Frame pre- and post-treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exercises for Gaze Stabilization Control Exercises
Hide Arm/Group Description Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
All-Cause Mortality
Exercises for Gaze Stabilization Control Exercises
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exercises for Gaze Stabilization Control Exercises
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercises for Gaze Stabilization Control Exercises
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/8 (0.00%)    
Nervous system disorders     
falls   0/13 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan J Herdman, PT, PhD
Organization: Emory
Phone: 4047120612
EMail: sherdma@emory.edu
Layout table for additonal information
Responsible Party: Susan Herdman, Emory University
ClinicalTrials.gov Identifier: NCT00411216     History of Changes
Other Study ID Numbers: IRB00000336
R01DC003196 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2006
First Posted: December 13, 2006
Results First Submitted: December 20, 2013
Results First Posted: July 21, 2014
Last Update Posted: August 7, 2015