- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07809243
Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population
Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population: Study Protocol for a Randomized Clinical Trial
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ke Zhang
- 전화번호: 852+53748502
- 이메일: ke.zhang@cevr.hk
연구 장소
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Hong Kong, 홍콩
- Units 901-903, 9/F, Building 17W, 17 Science Park West Avenue, Hong Kong Science Park, Pak Shek Kok, Shatin
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연락하다:
- Ke Zhang
- 전화번호: 852+53748502
- 이메일: ke.zhang@cevr.hk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Humphrey visual field analyzer (HFA) visual field loss (mean deviation of ≤-6 dB)
Exclusion Criteria:
- Comprehension disorder that does not allow understanding of tests or training (e.g., in severe aphasia)
- Currently under other PL treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Virtual Reality-based Perceptual Learning Training
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Prior to the training session, participants' visual fields will be assessed using standard automated perimetry (e.g., Humphrey Field Analyzer, 30-2 or 24-2 grid). Based on the decibel (dB) sensitivity maps from the clinical results, each participant's visual field will be classified into three functional zones: the intact zone (normal sensitivity), the absolute blind zone (<0 dB), and the transition zone or "gray area" (1~20 dB; relative scotoma characterized by reduced but present sensitivity). One training session will be 20 ~30 minutes for each task. Participants will be asked to complete a total of 6 training sessions. In each training session, the participant will be asked to complete two tasks (i.e., ecological multiple object tracking task and dual task) which will take approximately one hour. Training sessions will be spaced at intervals of 1~7 days. |
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간섭 없음: No-intervention Control
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Area Improvement
기간: Within one week after the training ends
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Primary outcome is the visual area measured using the HVF (24-2, SITA-standard), where sensitivity increased by 6 dB or more relative to baseline in the defective hemifield or whole field.
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Within one week after the training ends
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pre/post-intervention assessments of visual search
기간: Within one week after the training ends
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Visual search: Perceptual processing efficiency will be assessed using a visual search task - spatial configuration search task (Wolfe et al., 2010).
In this task, participants were instructed to fixate on the centre of the screen and to locate a target.
Each trial began with a short tone, followed after 500 ms by a search display.
Participants pressed a key to report whether the target was present (in 50% of trials) or absent, responding as quickly and accurately as possible.
Feedback-indicating response correctness-appeared for 500 ms after each trial.
Trials were separated by a 1000-ms inter-trial interval.
Set size was systematically varied across two conditions-6 items (1 target + 5 distractors) and 18 items (1 target + 17 distractors)-to quantify search efficiency.
For each participant, reaction time (RT) was regressed on set size, and the resulting slope served as the primary index of perceptual processing efficiency: shallower slopes indicate higher efficiency.
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Within one week after the training ends
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Pre/post-intervention assessments of balance ability
기간: Within one week after the training ends
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Balance: The Bertec Balance Advantage™ system is used to assess participants' balance before and after training.
During the test, participants are asked to stand under different challenging conditions.
Balance-challenging conditions include (1) standing on a firm or foam surface (Fi/Fo); (2) standing surface with backward or forward translation (BT/FT); and (3) standing with their eyes close (EC).
Outcome measures, including root mean square sway of the center of pressure in the anterior - posterior and medial -lateral directions (mm/s), total sway path length (mm), and maximum CoP displacement in the AP and ML directions (mm)
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Within one week after the training ends
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Pre/post-intervention assessments of fear of fall
기간: Within one week after the training ends
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Fear of fall: The English & Chinese version of the Falls Efficacy Scale-International (FES-I) is a validated and reliable questionnaire used to assess fear of falling in everyday life.
The FES-I total score ranges from 16 to 64.
Higher scores indicate greater concern about falling and therefore a worse outcome.
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Within one week after the training ends
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Pre/post-intervention assessments of quality of life (a)
기간: Within one week after the training ends
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The National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25), English and Chinese versions.
The NEI VFQ-25 scores range from 0 to 100.
Higher scores indicate better visual functioning and better vision-related quality of life and therefore represent a better outcome.
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Within one week after the training ends
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Pre/post-intervention assessments of quality of life (b)
기간: Within one week after the training ends
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The Chinese version of the Low Vision Quality of Life Questionnaire (CLVQOL) is used to assess vision-related quality of life.
The CLVQOL contains 25 items, each scored from 0 to 5, resulting in a theoretical total score ranging from 0 to 125.
Higher scores indicate fewer vision-related difficulties and better vision-related quality of life and therefore represent a better outcome.
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Within one week after the training ends
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- CEVR-PL-20260831
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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