Immersive Virtual Reality in Cognitive Rehabilitation of Patients With Post-Stroke Cognitive Impairment: A Pilot Study at the Department of Physical Medicine and Rehabilitation, Clinical Hospital of the University of Chile
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of VR-related adverse events requiring session interruption
研究概览
简要总结
This pilot study aims to evaluate the feasibility of implementing immersive virtual reality (VR) in cognitive rehabilitation for adults with post-stroke cognitive impairment receiving outpatient therapy. Participants will use a head-mounted display and interactive software to engage in gamified cognitive exercises that simulate memory, attention, and executive function tasks. The intervention consists of 10 sessions, delivered two to three times per week over a period of approximately four weeks. The study will assess multiple feasibility indicators, including the recruitment rate based on eligibility criteria, the safety and tolerability of VR sessions for participants, and the usability and satisfaction reported by occupational therapists administering the intervention. Additionally, exploratory outcomes include changes in global cognition and specific cognitive domains, as well as self-reported quality of life. Adverse effects related to VR use will be tracked. This pilot study will help inform the design and implementation of future, larger-scale clinical trials.
详细描述
This is a single-arm pilot study designed to evaluate the feasibility of implementing immersive virtual reality (VR) in cognitive rehabilitation for adults with post-stroke cognitive impairment. The study is conducted at the Occupational Therapy Unit of the Hospital Clínico Universidad de Chile and targets adult patients with documented cognitive impairment following a cerebrovascular accident (CVA).
Participants will undergo ten individual VR-assisted cognitive rehabilitation sessions, scheduled at a frequency of two to three sessions per week. Each session lasts approximately one hour, with the first 30 minutes incorporating immersive VR using the Meta Quest 3 headset and the Hand Physics Lab application. This application provides interactive cognitive exercises in a motivating and safe virtual environment. All sessions are supervised by occupational therapists trained in VR therapy.
The study aims to collect feasibility data, including recruitment rates based on inclusion and exclusion criteria, participant adherence to the intervention schedule, and reasons for withdrawal if any. Safety and tolerability will be assessed through patient-reported adverse effects (e.g., dizziness, nausea, or eye strain) using the Simulator Sickness Questionnaire (SSQ). Usability and satisfaction with the VR system will be evaluated from the perspective of the occupational therapists delivering the intervention.
Exploratory outcomes include changes in cognitive function measured with the Montreal Cognitive Assessment (MoCA) and in quality of life using the NeuroQoL short form. These measurements are taken before and after the intervention period. No compensation is provided for participation, and patients continue receiving standard care.
This pilot study does not aim to establish efficacy. Instead, it will provide essential data regarding the feasibility, safety, user experience, and preliminary clinical trends necessary to inform the development of future, larger-scale trials
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients with a cerebrovascular accident of any etiology with less than 3 months of progression
- •Patients with mild to moderate cognitive impairment post-stroke (impairment in at least one cognitive domain)
- •MoCA score of less than 24 points
- •Referred for cognitive rehabilitation at the Occupational Therapy Unit of HCUCH
排除标准
- •Patients with refractive errors that prevent the use of the headset
- •Patients with any type of aphasia that prevents the administration of the MoCA test
- •Patients with severe psychiatric disorders (presence of psychotic symptoms or derealization)
- •Patients with severe motor impairments (lack of trunk control or global strength of both upper limbs < M3)
研究组 & 干预措施
VR-based Cognitive Rehabilitation
Participants receive cognitive rehabilitation supported by immersive virtual reality using the Meta Quest 3 headset and the Kinesix XR application. Each session lasts 60 minutes, with the first 30 minutes involving VR-based cognitive tasks supervised by an occupational therapist. A total of ten sessions are completed over a period of approximately four weeks, with a frequency of two to three sessions per week. This arm is designed to assess the feasibility, safety, usability, and preliminary effects of VR-assisted rehabilitation in patients with post-stroke cognitive impairment.
干预措施: Kinesix XR on Meta Quest 3 (Device)
结局指标
主要结局
Incidence of VR-related adverse events requiring session interruption
时间窗: From first session to week 5 (after completion of the 10-session VR program)
Percentage of participants with one or more adverse events related to virtual reality that result in stopping a session, as documented in the patient's clinical record by the occupational therapist. Adverse events include, but are not limited to, nausea, dizziness, headache, and visual fatigue. In addition, symptoms associated with virtual reality will be monitored using the full Spanish-validated version of the Simulator Sickness Questionnaire (SSQ) after sessions 1, 5, and 10. The outcome measure will consider both sources of information -therapist-recorded clinical notes and SSQ scores- to identify and classify safety-related events.
Therapist-reported usability and satisfaction with immersive virtual reality in cognitive rehabilitation
时间窗: At week 5 (after completion of the 10-session VR program)
Therapist-reported usability and satisfaction with the immersive virtual reality intervention, measured using a custom-designed questionnaire rated on a 5-point Likert scale (1 = strongly disagree / very dissatisfied, 5 = strongly agree / very satisfied). The questionnaire includes five statements assessing ease of device setup, ability to personalize VR activities to the patient's cognitive needs, patient motivation during VR sessions, facilitation of active participation through immersion, and overall recommendation of the technology for cognitive rehabilitation. Total scores range from 5 to 25, with higher scores indicating greater usability and satisfaction. The questionnaire will be administered once, at week 5 (after completition of the 10-session VR program)
Proportion of participants who complete ≥80% of planned sessions.
时间窗: From first session to week 5 (after completion of the 10-session VR program)
Number of participants who complete at least 8 of 10 sessions divided by total enrolled participants.
次要结局
- Change in "Montreal Cognitive Assessment (MoCA)" score(Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program))
- Change in quality of life measured by NeuroQoL (Cognitive Function Short Form)(Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program))
研究者
Natalia Gattini
Asistant professor
University of Chile