Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.
详细描述
This clinical trial evaluates a cognitive rehabilitation program enhanced with virtual reality (VR) for older adults with mild cognitive impairment (MCI). The study investigates whether adding immersive VR exercises to a conventional program improves cognitive performance compared to standard cognitive rehabilitation alone.
All participants take part in a structured, computer-based cognitive training program delivered over 12 weeks. Sessions occur twice per week, with participants completing at least 20 and up to 22 sessions depending on clinic scheduling. The intervention group receives an additional 15-20 minutes of immersive VR content at the end of each session. VR exercises target attention, memory, and executive functioning, aiming to increase engagement and therapeutic value.
This trial complements a previously registered pilot study (ClinicalTrials.gov Identifier: NCT06155721) and builds on its published results.
Cognitive performance will be assessed using standardized neuropsychological tests including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Digit Span, Trail Making Test (TMT), and Symbol Digit Modalities Test (SDMT). Functional capacity will be evaluated using the Lawton-Brody scale. Usability and satisfaction with the VR system will be measured in the intervention group using the System Usability Scale (SUS) and a custom satisfaction questionnaire.
The study was implemented pragmatically within routine clinical care. Allocation followed the pre-existing attendance schedule of the psychogeriatric day hospital. For logistical and ethical reasons related to service implementation, one comparator group was later offered the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. Analyses will distinguish unique participants from rehabilitation episodes to account for this sequential access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking; participants and facilitators are aware of group allocation due to the nature of the intervention.
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
- •Adults aged ≥60 years, classified as having mild cognitive impairment or early cognitive impairment, with MMSE >20, regularly attending cognitive stimulation sessions at the CSSC day hospital and able to provide informed consent or consent through a legal representative.
排除标准
- •Severe or unstable illness interfering with participation, severe psychiatric symptoms that could be exacerbated by VR, severe visual or hearing impairment preventing participation, high sensitivity to motion sickness, epilepsy, or inability or unwillingness to provide informed consent.
研究组 & 干预措施
VR-Enhanced Cognitive Rehabilitation
Participants receive a computer-based cognitive rehabilitation program supplemented with immersive virtual reality exercises. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions.
干预措施: VR-Enhanced Cognitive Rehabilitation (Behavioral)
Standard Cognitive Rehabilitation
Participants receive a standard computer-based cognitive rehabilitation program. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions.
干预措施: Standard Cognitive Rehabilitation (Behavioral)
结局指标
主要结局
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
MoCA is a 30-point screening tool for global cognitive function, assessing memory, attention, language, visuospatial skills, and executive function. Score Range: 0 to 30 points \- Higher scores means better global cognition function
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
TMT-A measures visual attention and processing speed. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better visuospatial attention.
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
MMSE is a 30-point questionnaire evaluating orientation, attention, recall, language, and visual construction Score Range: 0 to 30 points. Higher scores means better global cognition function
Short-Term Memory as Measured by the Digit Span Test (Forward Span)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points Higher scores reflect better performance.
Working Memory as Measured by the Digit Span Test (Backward Span)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
TMT-B assesses alternating attention and executive control. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention.
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
SDMT: Symbol Digit Modalities Test. The Symbol Digit Modalities Test (SDMT) measures processing speed, attention, and visual-motor coordination. During the test, participants are required to match abstract symbols with corresponding numbers using a key. The total raw score is calculated as the number of correct symbol-digit pairs completed within a 90-second interval. There is no fixed maximum score, as it varies based on individual performance. Higher scores indicate better processing speed and cognitive performance.
Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale
时间窗: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
The Lawton-Brody Instrumental Activities of Daily Living Scale evaluates functional independence in activities such as telephone use, shopping, cooking, and managing finances. Scores range from 0 to 8, with higher scores indicating greater independence. Each task is scored as independent (1) or dependent (0).
次要结局
- Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)(Post-intervention (Week 12, within 1 week after last session))
- Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale(Post-intervention (Week 12, within 1 week after last session))
- Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)(Post-intervention (Week 12, within 1 week after last session))
- Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire(Post-intervention (Week 12, within 1 week after last session))
研究者
Jose Ferrer Costa
Medical Researcher and Project Manager
Badalona Serveis Assistencials