- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06136169
동종 시야 손실에 대한 알림 큐 스캐닝 훈련
동종 시야 손실이 있는 사람들을 위한 알림 신호 스캔 훈련
This study will evaluate a new approach to training people with visual field loss to scan when driving
연구 개요
상세 설명
Homonymous visual field loss is the loss of vision on the same side in both eyes. The most common types are hemianopia (the loss of one half of the field of vision) and quadrantanopia (the loss of one quarter of the field of vision). Hemianopia and quadrantanopia may cause difficulties in seeing objects on the side of the field loss. People with these types of field loss can compensate by scanning (looking) toward the side of the field loss. However, sometimes they might not scan sufficiently well resulting in delayed responses to hazards when driving. The purpose of this research study is to evaluate a new approach, "reminder-cue scanning training", to training people with homonymous visual field loss to scan when driving.
Participants will receive reminder-cue scanning training in the driving simulator.Typically there will be three training sessions within about a 2-week period. In addition, participants will complete an evaluation in the driving simulator before and after the training.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Schepens Eye Research Institute of Mass Eye and Ear
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Homonymous hemianopia or homonymous quadrantanopia for at least 3 months
- Binocular visual acuity of at least 20/40
- Prior or current driving experience
- Able to attend multiple study visits
- Able to communicate in English sufficiently to understand the study procedures
Exclusion Criteria:
- Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: StudyArm
Participants will receive reminder-cue scanning training in a driving simulator. |
Auditory reminders to scan when scanning to the side of the field loss is inadequate |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Early Large Head Scans to the Side of the Field Loss
기간: Pre-training, post-training (1 week)
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Percentage of intersections at which an early large head scan was made to the side of the field loss |
Pre-training, post-training (1 week)
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Detection Rate for Hazards on the Side of the Field Loss
기간: Pre-training, Post-training (1 week)
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Percentage of hazards detected out of the total number of hazards on the side of the field loss |
Pre-training, Post-training (1 week)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Head Scans to the Side of the Field Loss
기간: Pre-training, Post-training (1 week)
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Number of head scans per intersection to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 |
Pre-training, Post-training (1 week)
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Magnitude of Head Scans to the Side of the Field Loss
기간: Pre-training, Post-training (1 week)
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Mean magnitude (in degrees) of head scans to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). The magnitude is the lateral angular extent of the scan measured from the straight-ahead position to the furthest lateral position to the left or right. Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 |
Pre-training, Post-training (1 week)
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Response Times to Hazards on the Side of the Field Loss
기간: Pre-training, Post-training (1 week)
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Mean time (in seconds) between the hazard appearing and the horn-press response |
Pre-training, Post-training (1 week)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alex Bowers, PhD, Schepens Eye Research Institute of Mass Eye and Ear
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .