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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

pre-intervention and at discharge

Results posted on

2015-08-07

Participant Flow

Participant milestones

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

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

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 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).

Outcome measures

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 discharge

questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, 2 weeks, 4 weeks and at discharge

questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, 2 weeks, 4 weeks and at discharge

questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, 2 weeks, 4 weeks and at discharge

visual analoque scales

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, 2 weeks, 4 weeks and at discharge

gait speed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, 2 weeks, 4 weeks and at discharge

performance test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre- and post-treatment

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

Outcome measures

Outcome data not reported

Adverse Events

Exercises for Gaze Stabilization

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Exercises

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Susan J Herdman, PT, PhD

Emory

Phone: 4047120612

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place