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| Tracking Information | |||||
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| First Received Date ICMJE | December 12, 2006 | ||||
| Last Updated Date | December 12, 2006 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Visual acuity during head movement: Computerized Dynamic Visual Acuity test; measurement taken before intervention, at 2 and 4 weeks during intervention at at end of intervention | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Recovery of Visual Acuity in People With Vestibular Deficits | ||||
| Official Title ICMJE | Recovery of Visual Acuity in Vestibular Deficits | ||||
| 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. |
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| 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’. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 98 | ||||
| Completion Date | December 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00411216 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | RO1-DC 03196, NIH (NIDCD)ID:RO1-DC 03196, IRB ID:501-2000 | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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