Trial Outcomes & Findings for Recovery of Visual Acuity in People With Vestibular Deficits (NCT NCT00411216)
NCT ID: NCT00411216
Last Updated: 2015-08-07
Results Overview
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).
COMPLETED
NA
23 participants
pre-intervention and at discharge
2015-08-07
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Ten participants were entered into the c
|
0
|
2
|
Baseline Characteristics
Recovery of Visual Acuity in People With Vestibular Deficits
Baseline characteristics by cohort
| Measure |
Exercises for Gaze Stabilization
n=13 Participants
Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
|
Control Exercises
n=10 Participants
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
64.9 years
STANDARD_DEVIATION 16.2 • n=107 Participants
|
65.1 years
STANDARD_DEVIATION 16.3 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
10 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Visual acuity during head movements
|
.372 LogMAR
STANDARD_DEVIATION .155 • n=99 Participants
|
.323 LogMAR
STANDARD_DEVIATION .117 • n=107 Participants
|
.348 LogMAR
STANDARD_DEVIATION .136 • n=206 Participants
|
PRIMARY outcome
Timeframe: pre-intervention and at dischargevisual 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).
Outcome measures
| Measure |
Exercises for Gaze Stabilization
n=13 Participants
Experimental group performed vestibular adaptation and substitution exercises
gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements
|
Control Exercises
n=8 Participants
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
|
|---|---|---|
|
Change in Visual Acuity During Head Movement From Baseline to Discharge
|
0.198 LogMAR
Standard Deviation 0.101
|
.296 LogMAR
Standard Deviation .122
|
PRIMARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargequestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargequestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargequestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargevisual analoque scales
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargegait speed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-intervention, 2 weeks, 4 weeks and at dischargeperformance test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre- and post-treatmenteye 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
Outcome measures
Outcome data not reported
Adverse Events
Exercises for Gaze Stabilization
Control Exercises
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercises for Gaze Stabilization
n=13 participants at risk
Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
|
Control Exercises
n=8 participants at risk
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
|
|---|---|---|
|
Nervous system disorders
falls
|
0.00%
0/13
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place