Recovery of Visual Acuity in People With Vestibular Deficits

• Sponsor: Emory University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Exercises for Gaze Stabilization	Control Exercises
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

Baseline Characteristics

Arm/Group Title		Exercises for Gaze Stabilization	Control Exercises	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Change in Visual Acuity During Head Movement From Baseline to Discharge
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercises for Gaze Stabilization	Control Exercises
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):
Description	questionnaire
Time Frame	pre-intervention, 2 weeks, 4 weeks and at discharge

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Disability Scale
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
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
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
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)
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
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Exercises for Gaze Stabilization		Control Exercises
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	--/--		--/--
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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

Name/Title: Susan J Herdman, PT, PhD

Organization: Emory

Phone: 4047120612

EMail: sherdma@emory.edu

Publications of Results:

Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6.

Herdman SJ, Schubert MC, Tusa RJ. Role of central preprogramming in dynamic visual acuity with vestibular loss. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1205-10.

Schubert MC, Herdman SJ, Tusa RJ. Functional measure of gaze stability in patients with vestibular hypofunction. Ann N Y Acad Sci. 2001 Oct;942:490-1.

Schubert MC, Herdman SJ, Tusa RJ. Vertical dynamic visual acuity in normal subjects and patients with vestibular hypofunction. Otol Neurotol. 2002 May;23(3):372-7.

Herdman SJ, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in unilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):819-24.

Schubert MC, Das V, Tusa RJ, Herdman SJ. Cervico-ocular reflex in normal subjects and patients with unilateral vestibular hypofunction. Otol Neurotol. 2004 Jan;25(1):65-71.

Hall CD, Schubert MC, Herdman SJ. Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. Otol Neurotol. 2004 Sep;25(5):746-51.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Herdman SJ, Hall CD, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in bilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):383-9.

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