Recovery of Visual Acuity in People With Vestibular Deficits

NCT00411216 | Completed Results

• 2 other identifiers: IRB00000336R01DC003196
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. We hypothesize that the performance of specific adaptation and substitution exercises will result in an improvement in visual acuity during head movements while those patients performing placebo exercises will show no improvement.

Conditions

Vestibular Neuronitis; Vestibular Neuronitis, Bilateral; Vestibular Schwannoma

Keywords

vestibular rehabilitation; vestibular hypofunction

Outcome Measures

Primary Outcomes (2)

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

  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).

  pre-intervention and at discharge

• Subjective Complaints: (All Pre- and Post-intervention):

  questionnaire

  pre-intervention, 2 weeks, 4 weeks and at discharge

Secondary Outcomes (6)

• Disability Scale

  pre-intervention, 2 weeks, 4 weeks and at discharge

• Activities Specific Balance Confidence Scale

  pre-intervention, 2 weeks, 4 weeks and at discharge

• Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium

  pre-intervention, 2 weeks, 4 weeks and at discharge

• Balance and Gait

  pre-intervention, 2 weeks, 4 weeks and at discharge

• Fall Risk (Dynamic Gait Index)

  pre-intervention, 2 weeks, 4 weeks and at discharge

Study Arms (2)

exercises for gaze stabilization

EXPERIMENTAL

Experimental group performed vestibular adaptation and substitution exercises

Other: gaze stabilization exercises

Control exercises

PLACEBO COMPARATOR

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

Other: Control exercises

Interventions

Control exercises OTHER

saccadic eye movements against a plain background; no head movements

Control exercises

gaze stabilization exercises OTHER

adaptation and substitutin exercises encorporating retinal lsip and head movements

exercises for gaze stabilization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had to have either a unilateral vestibular or bilateral vestibular hypofunction defined as follows: Unilateral vestibular deficits were defined by a \> 25% difference in slow phase eye velocity between right and left sides on either the caloric or rotary chair test. Bilateral vestibular deficits were defined included refixation saccades made in response to unpredictable head thrusts to the right and left, a gain \< .1 on rotary chair step test and a peak slow phase eye movement of \<5 degrees/sec during irrigation of each ear on bithermal water caloric testing
• Healthy subjects with normal vestibular function test results
• must be able to complete DVA test

You may not qualify if:

• Patients with central lesions will be omitted from the study because vestibular adaptation or other compensatory mechanisms may be compromised and
• Patients with visual acuity when the head is stationary of 20/60 or worse.
• Patients on medication that suppress or facilitate vestibular function will not be excluded from the study but data will be analyzed to assess the effect of medication.
• Patient who do not understand the purpose of the study and what it involves

Sponsors & Collaborators

• Emory University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Center for Rehabilitation Medicine, Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (9)

• 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.

  PMID: 9831156 RESULT

• 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. doi: 10.1001/archotol.127.10.1205.

  PMID: 11587600 RESULT

• 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. doi: 10.1111/j.1749-6632.2001.tb03777.x. No abstract available.

  PMID: 11710496 RESULT

• 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. doi: 10.1097/00129492-200205000-00025.

  PMID: 11981398 RESULT

• 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. doi: 10.1001/archotol.129.8.819.

  PMID: 12925338 RESULT

• 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. doi: 10.1097/00129492-200401000-00013.

  PMID: 14724495 RESULT

• 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. doi: 10.1097/00129492-200409000-00017.

  PMID: 15354006 RESULT

• Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.

  PMID: 36809199 DERIVED

• 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. doi: 10.1001/archotol.133.4.383.

  PMID: 17438254 DERIVED

MeSH Terms

Conditions

Vestibular Neuronitis; Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Otorhinolaryngologic Neoplasms

Results Point of Contact

• Title: Susan J Herdman, PT, PhD
• Organization: Emory

sherdma@emory.edu

4047120612

Study Officials

• Susan J Herdman, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: August 1, 2000
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: August 7, 2015
• Results First Posted: July 21, 2014

Record last verified: 2015-07

Locations

US (1)