- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02310880
Efficacy of Enhancing Low Vision Mobility Thru Visual Training in Virtual World
2015년 5월 25일 업데이트: University of Alabama at Birmingham
Low vision patients have difficulty acquiring sufficient visual information in a timely manner for the purpose of performing challenging daily tasks, such as traveling independently and safely through busy streets.
The advance of virtual reality techniques has provided a potential platform for training low vision patients to use their remaining vision more efficiently, but the key issue is always whether the patient's visual experiences in a virtual world can be transferred to the real world.
The proposed study is designed to provide definite answer to this question.
연구 개요
상태
완전한
정황
상세 설명
NEI's National Plan for Eye and Vision Research has identified Low Vision and Blindness Rehabilitation as one of the most pressing needs and opportunities in vision research.
Since most low vision (LV) patients nowadays have useable vision, an important aspect of LV rehabilitation is to maximize the use of the patient's remaining vision.
Visual skills are especially important in tasks such as traveling independently through busy streets, in which distant, rapidly changing events have direct impact on the patient's task efficiency and safety.
The patient has to learn new information acquisition skills to compensate for their impaired vision.
Current LV training for such skills is done on real streets in a one-on-one, trainer/trainee sessions.
This way of training, however, usually does not expose clients to all the circumstances that they need to deal with, usually does not provide graded levels of task difficulty and repeatable conditions that facilitate learning, and cannot meet the needs of the majority of LV patients because of the shortage and the high cost of LV trainers.
The advances of virtual reality (VR) technology have made it possible and affordable to realistically simulate complex and dynamic visual and auditory environments to facilitate LV rehabilitation.
However, the most important first step in applying VR technologies to LV rehabilitation is to determine whether the visual experiences of a LV person can be transferred to the real world.
Only when a positive transfer of visual skills is confirmed, can subsequent development of comprehensive VR training systems for all aspects of LV rehabilitation become worthwhile.
The purpose of this study is to accomplish this first step.
A set of visual skills for a most visually challenging task, crossing a signal-controlled street, is selected from standard orientation and mobility curriculum to study virtual experience transfer.
Existing technology are used to build a desktop computer-based VR simulator that can generate virtual street intersection scenarios that contain visual and auditory information required for practicing the skills to be studied.
Computer generated street intersections with pedestrians, traffic and control signals are projected to a large screen for the participant to view, like a movie.
Twenty LV persons are recruited from a university LV rehabilitation facility.
They are randomly assigned to practicing the selected visual skills at real or virtual street intersections.
Their skill levels are evaluated at real intersections before and immediately after their scheduled training.
The primary outcome of interest is the mean change of visual skills between pre- and post-training evaluations in the two groups.
The training is not a rehabilitation intervention because only the changes in visual/audio information gathering skills are trained and observed.
The participants are trained and evaluated on the sidewalks of the real and virtual street.
They are never allowed to step down the curb to avoid exposure to any danger.
The long-term goal is to develop interactive VR training systems that have multiple sensory and motor input and output modules and that incorporate the collective experiences of the LV rehabilitation profession.
Adding such systems to LV curriculum can greatly improve the affordability, accessibility, efficiency and the scope of LV rehabilitation.
연구 유형
관찰
등록 (실제)
35
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35294
- The Clinical Eye Research Facility
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
19년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Low vision participants will be recruited from the patient populations of the Clinics of UAB School of Optometry and UAB Center for Low Vision Rehabilitation
설명
Inclusion Criteria:
- Ambulatory and have independent traveling as one of their rehabilitation goals.
- Participants with central field loss should have best corrected binocular visual acuity between 20/200 and 20/1000, but with relatively intact peripheral visual field (>80o).
- Participants with peripheral visual field loss should have >20/63 visual acuity and no more than 20 deg diameter but not less than 8 deg diameter visual field in the better eye.
Exclusion Criteria:
- Participants who have a mixture of central and peripheral field loss.
- Previous or current recipient of O&M training.
- Participants who have plans to receive O&M training during the study period.
- Age younger than 19 or older than 81.
- Significant cognitive impairment as determined with the Short Portable Mental Status Questionnaire (≥2 errors); inability to understand and speak English.
- Severe hearing impairment that interferes with interactions with O&M specialists.
- Inability or unwillingness to make visits required by the study.
- Not living in the Birmingham-Jefferson county area.
- Persons who have a history of epilepsy or who are prone to motion sickness or simulator aftereffect, determined by an epileptic seizure history inquiry and a Motion Sickness History Questionnaire.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Low vision (virtual street training)
Low vision subjects trained in virtual streets and observed in real streets
|
|
Low vision (real street training)
Low vision subjects trained in real streets and observed in real streets
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The percentage of dangerous street crossing decisions and the street crossing decision safety scores
기간: 3-5 1-hour visits
|
The percentage of dangerous street crossing decisions is determined at real street corners during pre- and post-training evaluation sessions.
The subject is asked to say "GO" when she feels it is the safest time to cross the street.
A crossing decision is scored as dangerous if it is initiated in the red traffic light cycle or if there is < 25% of the "WALK" cycle left.
The percentage is the total number of dangerous decisions divided by the total number of crossing decisions made during one evaluation session.
The safety of a crossing decision is further quantified by recording the decision timing using a stopwatch and by converting the recorded time to a safety score.
The safety score is a continuous scale between 0 and 1.0.
The larger the safety score, the safer is the crossing decision.
A statistically significant reduction in the percentage dangerous crossing decisions and an increase in the safety scores after training is an indication of successful skill learning and transfer.
|
3-5 1-hour visits
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 9월 1일
기본 완료 (실제)
2015년 3월 1일
연구 완료 (실제)
2015년 3월 1일
연구 등록 날짜
최초 제출
2014년 12월 3일
QC 기준을 충족하는 최초 제출
2014년 12월 4일
처음 게시됨 (추정)
2014년 12월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 25일
마지막으로 확인됨
2014년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .