Recovery of Visual Acuity in People With Vestibular Deficits

NCT ID: NCT00411216

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2004-12-31

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.

Detailed Description

Decrements in visual acuity during head movement in patients with vestibular hypofunction are potentially serious problems. This deficit could contribute to decreased activity level, avoidance of driving with resultant diminished independence and, ultimately, limited social interactions and increased isolation. Oscillopsia occurs because of inadequate vestibulo-ocular reflex (VOR) gain and suggests that compensation for the vestibular loss has not occurred. The purpose of this study was to examine the effect of an exercise intervention on visual acuity during head movement in patients with unilateral and bilateral vestibular hypofunction. We hypothesized that 1) patients performing vestibular exercises would have improved visual acuity during head movement compared to patients performing placebo exercises; 2) there would be no correlation between dynamic visual acuity (DVA) and the patients' subjective complaints of oscillopsia; and 3) improvement in DVA would be reflected by changes in residual vestibular function as indicated by an increase in VOR gain.

Patients are assigned randomly to either the vestibular exercise or placebo exercise group. The randomization schedule is generated using a computer program for 2-sample randomization. The sequence was not concealed from the investigator who obtained consent from the subjects and supervised the exercises (SJH). The group assignment (vestibular exercise or placebo exercise) was concealed from the participants and from the investigator who performed the outcome measures.

The vestibular exercise group practiced exercises that consisted of adaptation exercises and eye-head exercises to targets (Table 1), which were designed to improve gaze stability 16. They also performed gait and balance exercises. The placebo exercise group performed exercises designed to be 'vestibular-neutral'.

Conditions

Vestibular Neuronitis; Vestibular Neuronitis, Bilateral; Vestibular Schwannoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

exercises for gaze stabilization

Experimental group performed vestibular adaptation and substitution exercises

Group Type: EXPERIMENTAL

gaze stabilization exercises

Intervention Type: OTHER

adaptation and substitutin exercises encorporating retinal lsip and head movements

Control exercises

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

Group Type: PLACEBO_COMPARATOR

Control exercises

Intervention Type: OTHER

saccadic eye movements against a plain background; no head movements

Interventions

Control exercises

saccadic eye movements against a plain background; no head movements

Intervention Type: OTHER

gaze stabilization exercises

adaptation and substitutin exercises encorporating retinal lsip and head movements

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Susan Herdman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan J Herdman, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Center for Rehabilitation Medicine, Emory University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 9831156 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11587600 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11710496 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11981398 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12925338 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14724495 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15354006 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36809199 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17438254 (View on PubMed)

Other Identifiers

R01DC003196

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00000336

Identifier Type: -

Identifier Source: org_study_id