Automated Orientation & Mobility Training in Virtual Reality for Low Vision Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Pre-Training Proportion of Success
研究概览
简要总结
The human subject research is a randomized, controlled training trial that tests the effectiveness of three Virtual Reality-based Intelligent Orientation and Mobility Specialists (VR-IOMSs) in teaching orientation and mobility (O&M) task skills to low vision patients. It will be conducted on two sites, University of Alabama at Birmingham (UAB) and Alabama Institute for Deaf and Blind (AIDB). The same protocol will be used on both sites. UAB will be the sIRB for the trial.
Three O&M tasks will be studied, timing to cross a signalized street using the near lane parallel traffic surge skill, timing to cross an uncontrolled street using the traffic gap judgment skill and learning outdoor numbering system. A VR-IOMS will be develop for each task. The training does not involve research subjects walking into street traffic.
Low vision subjects who have difficulties with these O&M tasks due to their impaired vision will be randomized into three groups, learning the task from a VR-IOMS (experimental group), from a human Certified Orientation & Mobility Specialist (COMS) in real streets (active control group) and not learning the task but spending the same amount of time watching low vision education videos (placebo group). All subjects will be evaluated by COMSs in real streets around the two study sites before training (pre-training), within 3 days after the completion of training (post-training) and 3 months after the completion of training (follow up). Their ability to perform the O&M tasks will be assess quantitatively using objective methods. COMSs who conduct these evaluations will be blinded for subject training assignment.
The primary outcome measure is the training effect, the difference in task performance between the pre-training and post-training real street evaluations. The training effects of the 3 groups will be compared to determine the training effectiveness of the VR-IOMS relative to human COMS. Secondary outcome measures include the retainment of the training effect. Objective assessment of the VR-IOMS training process and trainee subjective evaluation of the VR-IOMS training will also be analyzed.
详细描述
The human subject research is a randomized, controlled training trial that tests the effectiveness of three Virtual Reality-based Intelligent Orientation and Mobility Specialists (VR-IOMSs) in teaching orientation and mobility (O&M) task skills to individuals with low vision (LV). It will be conducted on two sites, University of Alabama at Birmingham (UAB) and Alabama Institute for Deaf and Blind (AIDB). The same protocol will be used on both sites. UAB will be the sIRB for the trial.
Three O&M tasks will be studied, timing to cross a signalized street using the near lane parallel traffic surge skill (Task NLPT), timing to cross an uncontrolled street using the traffic gap judgment skill (Task TGJ) and learning outdoor numbering system (Task ONS). A VR-IOMS will be developed and validated for each task. The training does not involve research subjects walking into street traffic.
Low vision subjects who have difficulties with these O&M tasks due to their impaired vision will be recruited from UAB and AIDB according to procedures approved by UAB IRB. Specifically, clinicians of UAB Center for Low Vision Rehabilitation will identify potential study subjects from records of existing patients and from new patient population. Recruitment letters from the clinicians will be sent to potential subjects. Patients who are interested in participating will initiate contact with UAB research team for initial evaluation and scheduling an enrollment visit. Certified O&M specialist (COMS) faculty of AIDB's School for the Blind, the Gentry Facility and Alabama Freedom Center for the Blind will identify potential study subjects from new students/clients and will use a recruitment script to inform them about the study. Students/clients who are interested will contact the AIDB team to arrange initial evaluation and enrollment session.
Initial evaluation includes inquiries of visual and hearing impairment, mental status and O&M training history. Potential subjects who pass the initial evaluation will attend an enrollment session where demographic information will be collect, visual and hearing functions will be assessed, if necessary and functional vision and ability to perform the study O&M tasks will be evaluated by COMS on real streets. Informed consent/assent material approved by UAB IRB will be presented to potential subjects who meet the inclusion criteria and/or their legally authorized representatives. Research activity will not begin until written informed consent/assent is obtained according to approved procedure.
Enrolled subjects will be randomized into three groups, learning the task from a VR-IOMS (experimental group), from a human COMS in real streets (active control group) and not learning the task but spending the same amount of time watching LV education videos (placebo group). All subjects will be evaluated by COMSs in real streets around the two study sites before training (pre-training), within 3 days after the completion of training (post-training) and 3 months after the completion of training (follow up). Their ability to perform the O&M tasks in real streets will be assessed quantitatively using objective methods. Specifically, in Task NLPT, the performance is measured by a safety score, which is determined by the time of the onset of the steady pedestrian WALK signal, the time when the first straight going car in the same direction as the traveler's crossing direction entering the street intersection and the time when the subject decides to start crossing (say GO). These times will be measured by the COMS using a stopwatch. The safety score, ranges from 0 to 1, represents the proportion of the duration of the pedestrian phase after the subject says GO. A larger score indicate a larger portion of pedestrian phase is available for the subject to walk across the street and is thus safer. A GO call in the steady DON'T WALK phase will be recorded as a negative number and is unsafe. This safety score was developed and used in the investigators' pilot research. The rule of thumb used by COMSs, start crossing within 7 seconds after the onset of the pedestrian WALK signal, will also be used. In Task TGJ, the performance is measured by a safety margin, which is the traffic gap width in seconds (the time interval in seconds between the first and second car passing in front of the traveler) minus the delay of the subject's crossing decision (say GO) and minus the time needed for the subject to walk across the street at the participant's preferred walking speed. Validated objective methods to measure the three times involved in safety margin determination have been used in previous studies of low vision patient TGJ performance and will be used in this research. A positive safety margin represents the time left of the traffic gap when the subject has reached the opposite side of the road, thus indicates a safe crossing decision. A negative safety margin represents the time when the subject is still in the road after the traffic gap has closed. It indicates an exposure of the subject to the traffic and thus indicates an unsafe decision. In Task ONS, the performance is measured by the correctness of the subject's plan to reach a destination in the neighborhood. The subject earns two points for making no error in the direction and the side of street of the destination, earns 1 point for getting one wrong and earns no point for getting both wrong. The subject will not walk into the traffic in any of the task evaluations in real streets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Separate Certified Orientation & Mobility Specialists (COMS) conduct training and outcome evaluation
入排标准
- 年龄范围
- 13 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have stable, late-onset visual impairment.
- •Not have had formal O&M training. Potential participants will be taken to real streets by COMS and their performance on the 3 studied tasks will be evaluated.
- •Following visual function requirements for the three studied O&M tasks
- •Task NLPT: best corrected visual acuity of 20/650 or worse
- •Task TGJ:
- •central vision loss - acuity 20/100-20/300, radius of field 50-80 deg
- •peripheral vision loss - acuity 20/15-20/100, radius of field 5-55 deg
- •Task ONS: visual function requirements for both Tasks NLPT & TGJ
- •Possess sufficient functional vision to learn the O&M tasks (evaluated by COMS in real streets)
- •Have O&M as a rehabilitation goal
- •Normal or corrected to normal hearing
- •No cognitive impairment (Montreal Cognitive Assessment (MoCA) or MoCA-blind (MoCA-B) score exceeds education-adjusted cutoffs)
- •Dexterity to operate a pointing mouse or a joystick
- •Physical stamina to walk a few street blocks under guidance of COMSs and to stand or sit for 30-min training sessions on the street or in the VR simulator
排除标准
- •Patients in the rapid progression phase of ocular diseases, such as wet macular degeneration
- •Patients under aggressive treatment of ocular diseases, such as VEGF injection for retinal diseases
- •Patients with congenital visual impairment will be excluded.
- •Participants will be excluded from the training for the skills that they already master.
- •Participants who have a history of epileptic seizure or are prone to motion sickness will be excluded.
- •Have difficulty in verbal communication in English.
研究组 & 干预措施
Orientation and Mobility Training with VR-IOMSs
Low vision subjects with Orientation and Mobility (O&M) difficulties learning O&M skills from Virtual Reality-base Intelligent O&M Specialists (VR-IOMSs). VR-IOMSs are intelligent, computer-controlled automatic O&M skill training programs in virtual streets.
干预措施: Orientation and Mobility Training with VR-IOMSs (Behavioral)
No Orientation and Mobility Training
Low vision subjects with Orientation and Mobility (O&M) difficulties watching low vision education videos and discuss low vision issues not related to O&M with COMSs.
干预措施: No Orientation and Mobility Training (Behavioral)
Orientation and Mobility Training with COMS
Low vision subjects with Orientation and Mobility (O&M) difficulties learning O&M skills from human Certified O&M Specialists (COMS) in real streets
干预措施: Orientation and Mobility Training with COMS (Behavioral)
结局指标
主要结局
Pre-Training Proportion of Success
时间窗: Within 3 days before commencement of Orientation and Mobility training
Proportion of O\&M Task Success (In NLPT training, a success is a safe timing to cross street; in MBC, a success is a safe decision to cross or no cross a street; in ODNS, a success is a good trip plan to visit an unfamiliar address). Numbers are all between 0 and 1.
Post-Training Proportion of Success
时间窗: Within 1 week after completion of Orientation and Mobility training
Proportion of O\&M Task Success (In NLPT training, a success is a safe timing to cross street; in MBC, a success is a safe decision to cross or no cross a street; in ODNS, a success is a good trip plan to visit an unfamiliar address). Numbers are all between 0 and 1.
次要结局
- Number of Participants That Completed the Subjective Learning Experience With VR-IOMS(Within 30 minutes after completion of VR-IOMS training)
- Number of Participant Reponses to the Post VR-IOMS Training Experience Survey(Within 30 minutes after completion of VR-IOMS training)
- Training Course Completion Duration (the Time Between the Start of the Training Course to the End. Measured by Computer or by Watch)(From the commencement of orientation & mobility training to its completion (may spread in multiple days) / within one week)
研究者
Lei Liu
Professor
University of Alabama at Birmingham
