Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
研究概览
简要总结
The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli.
The main questions it aims to answer are:
- Will patients with mild cognitive impairment find the VR program enjoyable and easy to use?
- Can VR interventions help improve patients' cognitive functions, specifically attention and memory?
- Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice?
Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will:
- Engage with a VR-based cognitive stimulation program.
- Undergo assessments of the participants´ cognitive functions before and after the intervention.
- Provide feedback on the participants´ experience with the VR program.
Researchers will analyze the data to see if:
- The VR program leads to noticeable improvements in the cognitive abilities of participants.
- The program is well-received and deemed beneficial by both patients and healthcare professionals.
详细描述
Background:
Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.
Study Design:
This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking was involved in this study as all participants received the same intervention (the cognitive stimulation program using virtual reality created in collaboration with Reality Telling SL), and the open-label nature of the intervention made it impractical to blind participants or researchers to the treatment being provided.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than
- •Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC).
- •Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.
排除标准
- •Patients with a severe or unstable illness that could interfere with participation in the study.
- •Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality.
- •Patients with severe visual limitations that would prevent the use of virtual reality.
- •Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses.
- •Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids.
- •High sensitivity to motion sickness.
- •Subjects with epilepsy.
- •Patients who are unable or unwilling to give informed consent.
- •Withdrawal Criteria
- •The emergence of health problems that could interfere with the continuity of participation in the study, or the withdrawal of consent by the participant.
研究组 & 干预措施
Virtual Reality Cognitive Stimulation Program
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists.
The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI).
干预措施: Virtual Reality Cognitive Stimulation Program (Device)
结局指标
主要结局
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
时间窗: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.
Comfort of VR Headset as Measured by an 8-Item SUS:
时间窗: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).
次要结局
- Working Memory as Measured by the Digit Span Test (DST Backward Span)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:(immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Global Cognition as Measured by the Mini-Mental State Examination (MMSE)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Executive Function as Measured by the Trail Making Test Part B (TMT-B)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
- Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)(Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8))
研究者
Jose Ferrer Costa
Principal Investigator
Badalona Serveis Assistencials