Trial Outcomes & Findings for Virtual Reality Mobility Training System for Veterans With Vision Loss (NCT NCT00333879)

Results Overview

Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me. Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject. The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

4 trials over 30 minutes after 30 minutes of training

Results posted on

2013-12-16

Participant Flow

The 4 totally blind Participants were recruited over three months (April - June) 2009 from the Atlanta Center for Visual Impairment.

All 4 subjects were accepted for the study. None were excluded.

Participant milestones

Participant milestones
Measure	Virtual Sound System Efficacy of using a virtual sound system to simulate street crossing conditions.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality Mobility Training System for Veterans With Vision Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Sound System n=4 Participants Efficacy of using a virtual sound system to simulate street crossing conditions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 trials over 30 minutes after 30 minutes of training

Population: Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.

Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me. Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject. The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant.

Outcome measures

Outcome measures
Measure	Virtual Sound System n=4 Participants Efficacy of using a virtual sound system to simulate street crossing conditions.
Accuracy in Judging Direction of Traffic at Traffic Intersection	0 participants

SECONDARY outcome

Timeframe: 4 trials over 30 minutes after 30 minutes of training

Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion. The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject.

Outcome measures

Outcome measures
Measure	Virtual Sound System n=4 Participants Efficacy of using a virtual sound system to simulate street crossing conditions.
Accuracy in Selecting Appropriate Time to Cross Street	0 participants

Adverse Events

Virtual Sound System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Ross

Atlanta VA Rehab R&D Center

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place