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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC003196 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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'.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercises for gaze stabilization | Experimental | Experimental group performed vestibular adaptation and substitution exercises |
|
| Control exercises | Placebo Comparator | Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control exercises | Other | saccadic eye movements against a plain background; no head movements |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Scale | questionnaire | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Activities Specific Balance Confidence Scale | questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Herdman, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Rehabilitation Medicine, Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9831156 | Result | 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. | |
| 11587600 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercises for Gaze Stabilization | Experimental group performed vestibular adaptation and substitution exercises gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements |
| FG001 | Control Exercises | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercises for Gaze Stabilization | Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements |
| BG001 | Control Exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | LogMAR | pre-intervention and at discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercises for Gaze Stabilization | Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| falls | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan J Herdman, PT, PhD | Emory | 4047120612 | sherdma@emory.edu |
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| ID | Term |
|---|---|
| D020338 | Vestibular Neuronitis |
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| gaze stabilization exercises | Other | adaptation and substitutin exercises encorporating retinal lsip and head movements |
|
| pre-intervention, 2 weeks, 4 weeks and at discharge |
| Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium | visual analoque scales | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Balance and Gait | gait speed | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Fall Risk (Dynamic Gait Index) | performance test | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Eye Movements: Scleral Search Coil | 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 | pre- and post-treatment |
| 11710496 | 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. |
| 11981398 | 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. |
| 12925338 | 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. |
| 14724495 | 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. |
| 15354006 | 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. |
| 36809199 | Derived | 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. |
| 17438254 | 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. |
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Visual acuity during head movements | Mean | Standard Deviation | LogMAR |
|
| Control Exercises |
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 |
|
|
| Primary | Subjective Complaints: (All Pre- and Post-intervention): | questionnaire | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Disability Scale | questionnaire | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Activities Specific Balance Confidence Scale | questionnaire | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium | visual analoque scales | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Balance and Gait | gait speed | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Fall Risk (Dynamic Gait Index) | performance test | Not Posted | pre-intervention, 2 weeks, 4 weeks and at discharge |
| Secondary | Eye Movements: Scleral Search Coil | 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 | Not Posted | pre- and post-treatment |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Control Exercises | Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements | 0 | 8 | 0 | 8 |
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| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |