Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411216
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2006-12-12
Brief Title:
Recovery of Visual Acuity in People With Vestibular Deficits
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Recovery of Visual Acuity in Vestibular Deficits
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DC003196 | NIH | None | httpsreporternihgovquickSearchR01DC003196 |