Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population: Study Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Area Improvement
研究概览
简要总结
Visual impairments significantly impact individuals' activities of daily living (ADL) and quality of life (QoL). While perceptual learning (PL) has shown promise in vision rehabilitation, traditional PL usually involves a protracted training process, and its training effects may sometimes lack ecological validity. This study protocol outlines a two-arm, single-blind, randomized controlled trial to evaluate the efficacy of an innovative virtual reality (VR)-based PL therapy integrated with machine learning algorithms. Twenty participants with visual field deficits will be recruited and randomized in a 1:1 ratio into either the VR training group or a no-intervention control group. The intervention consists of six visits (1-7 days apart), each involving two training tasks (20 - 30 minutes per task). The VR training task is an Ecological Multiple Object Tracking task and a Dual task. Training stimuli are personalized to target each participant's transition zone (1~20 dB) based on the result of clinical visual field test. A Deep Reinforcement Learning (DRL) framework, specifically the Proximal Policy Optimization (PPO) algorithm, is utilized as an adaptive controller to dynamically modulate task difficulty and maintain participants in an optimal cognitive "flow state". The primary outcome is visual field area improvement (measured by Humphrey Field Analyzer). Secondary outcomes include pre- and post-intervention assessments of visual search, balance ability, fear of falling, ADL, and QoL. It is hypothesized that participants in the VR training group will obtain improvements in primary and secondary outcomes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Humphrey visual field analyzer (HFA) visual field loss (mean deviation of ≤-6 dB)
排除标准
- •Comprehension disorder that does not allow understanding of tests or training (e.g., in severe aphasia)
- •Currently under other PL treatment
研究组 & 干预措施
Virtual Reality-based Perceptual Learning Training
干预措施: Virtual Reality-based Perceptual Learning Training (Behavioral)
No-intervention Control
结局指标
主要结局
Visual Area Improvement
时间窗: Within one week after the training ends
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.
次要结局
- Pre/post-intervention assessments of visual search(Within one week after the training ends)
- Pre/post-intervention assessments of balance ability(Within one week after the training ends)
- Pre/post-intervention assessments of fear of fall(Within one week after the training ends)
- Pre/post-intervention assessments of quality of life (a)(Within one week after the training ends)
- Pre/post-intervention assessments of quality of life (b)(Within one week after the training ends)
