Feasibility of Occupation-Based Immersive Virtual Reality for Upper-Limb Rehabilitation After Stroke
Pilot Feasibility Study of an Occupation-Based Immersive Virtual Reality Intervention for Upper-Limb Rehabilitation After Stroke
This ongoing, single-group pilot feasibility study aims to evaluate the feasibility, usability, and acceptability of an occupation-based immersive virtual reality (IVR) rehabilitation program for adults with stroke-related upper-limb impairment. The study has an anticipated enrollment of 20 participants, of whom eight were enrolled during the initial recruitment period.
The intervention consists of 12 supervised sessions per participant, each including approximately 30 minutes of virtual activities delivered through two custom-developed IVR applications, Virtual Gardening and Virtual Painting, using a Meta Quest 2 head-mounted display (HMD). The intervention is provided as an adjunct to usual occupational therapy.
The study examines intervention completion, session delivery, gameplay duration, technical interruptions, safety, user satisfaction, symptoms associated with virtual reality exposure, and participation during rehabilitation sessions. Upper-limb motor function and independence in activities of daily living are also assessed as exploratory clinical outcomes.
The primary aim is to determine whether this occupation-based IVR rehabilitation program can be feasibly implemented in clinical practice and to identify areas for improvement before larger-scale studies. The study is not designed to establish the effectiveness of the intervention compared with conventional rehabilitation.
研究概览
详细说明
The intervention was developed through a stakeholder-informed process that incorporated occupational therapists' perspectives, stroke survivors' activity preferences, task-level characterization, and preliminary usability evaluation. Two custom-developed IVR applications, Virtual Gardening and Virtual Painting, were implemented using Unity and delivered through a Meta Quest 2 HMD.
This ongoing, single-group pilot feasibility study has an anticipated enrollment of 20 adults with stroke-related upper-limb impairments. Eight participants were enrolled during the initial recruitment period, and recruitment is continuing toward the planned sample size. Participants are scheduled to receive 12 supervised IVR sessions as an adjunct to their usual occupational therapy.
Each session is planned to include approximately 30 minutes of virtual activities: 10 minutes of structured Gardening, 10 minutes of structured Painting, 5 minutes of free Gardening, and 5 minutes of free Painting. Rest breaks and therapist assistance are provided according to individual needs.
The applications include graded activities involving reaching, object interaction, upper-limb coordination, and creative engagement. Different interaction modes, including affected-hand interaction and mirrored control using the unaffected hand, are available to accommodate individual functional abilities. All activities are performed in a seated position under therapist supervision.
Exploratory clinical outcomes include upper-limb motor impairment, assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), and independence in activities of daily living, assessed using the Barthel Index. Both measures are administered at baseline (before the first intervention session) and after completion of session 12.
User satisfaction and experience are assessed using the User Satisfaction Evaluation Questionnaire (USEQ), while symptoms associated with virtual reality exposure are monitored using the Simulator Sickness Questionnaire (SSQ). Both questionnaires are administered after intervention sessions 1, 6, and 12.
Participation during rehabilitation is assessed by the therapist using the Pittsburgh Rehabilitation Participation Scale (PRPS) during each intervention session (sessions 1-12).
The study is conducted in supervised rehabilitation settings in Larissa, Greece. Its primary purpose is to examine the feasibility, usability, safety, and acceptability of the occupation-based IVR intervention and to inform the design of future larger-scale investigations. As a single-group pilot feasibility study without a control group, it is not designed to establish treatment efficacy or comparative effectiveness against conventional rehabilitation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dimosthenis Lygouras, MSc
- 电话号码：+306982897261
- 邮箱：dlygoura@cs.duth.gr
学习地点
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Thessaly
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Larissa、Thessaly、希腊
- 招聘中
- Adult Day Care Center Agkaliazhn
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接触：
- Aggelikh Karagkounh, BSc
- 电话号码：+30 2410663130
- 邮箱：larissa@agkaliazin.gr
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Larissa、Thessaly、希腊
- 招聘中
- Animus Rehabilitation & Recovery Center
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接触：
- Fwteinh Kechagia, BSc
- 电话号码：+302410851851
- 邮箱：info@animus.com.gr
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首席研究员：
- Dimosthenis Lygouras, MSc
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Confirmed diagnosis of ischemic or hemorrhagic stroke.
- Age between 18 and 90 years.
- First-ever or recurrent stroke associated with acquired motor impairment of the upper limb.
- Stroke occurring at least 2 months before enrollment.
- Sufficient cognitive and communicative ability to understand study instructions and complete the questionnaires, defined as a Mini-Mental State Examination (MMSE) score of 24 or higher.
- Ability to safely participate in an immersive virtual reality (IVR) session using the Meta Quest 2.
- Greek as the participant's primary language.
Exclusion Criteria:
- Need for continuous medical monitoring or medical care that could not be safely accommodated during study procedures.
- Active medical conditions that could interfere with participation or safe IVR exposure, including acute fractures, active skin ulcers, uncontrolled cardiovascular, circulatory, hepatic, or renal conditions, and other clinically significant unstable comorbidities.
- Epilepsy or a history of seizures considered clinically relevant to IVR exposure.
- Uncontrolled diabetes mellitus or hypertension.
- Active malignancy requiring urgent treatment.
- Severe aphasia or other communication impairments preventing the participant from understanding instructions or completing study questionnaires.
- Significant visual impairment incompatible with the use of the Meta Quest 2.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Occupation-Based Immersive Virtual Reality Rehabilitation
Participants receive a 12-session, therapist-supervised, occupation-based IVR rehabilitation program as an adjunct to conventional occupational therapy. The program includes two custom-developed virtual activities, Virtual Gardening and Virtual Painting, delivered using a Meta Quest 2. Activities include structured, graded tasks and free exploration, with interaction modes adapted to participants' upper-limb functional abilities. Participants continue to receive their usual occupational therapy throughout the study. |
The intervention consists of 12 supervised immersive virtual reality (IVR) sessions using two occupation-based applications: Virtual Gardening and Virtual Painting. Each session is planned to include approximately 30 minutes of virtual activities: 10 minutes of structured Gardening, 10 minutes of structured Painting, 5 minutes of free Gardening, and 5 minutes of free Painting. Gardening activities include reaching toward leaves, harvesting virtual olives, planting seeds, and watering plants. Painting activities include tracing geometric and representational shapes and creating drawings using virtual brushes and colours. The applications provide graded task difficulty, affected-hand interaction, mirrored control using the unaffected hand, and free exploration. Participants interact with the virtual environment using a Meta Quest 2 head-mounted display and controllers while seated, under therapist supervision. Rest breaks and assistance are provided according to individual needs. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intervention Completion Rate
大体时间：From enrollment to completion of the 12-session intervention (approximately 4 weeks per participant).
|
Percentage of enrolled participants who completed the planned 12-session immersive virtual reality rehabilitation program. Calculated as the number of participants completing the intervention divided by the total number enrolled, multiplied by 100. |
From enrollment to completion of the 12-session intervention (approximately 4 weeks per participant).
|
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Session Delivery Rate
大体时间：Throughout the 12-session intervention period (approximately 4 weeks per participant).
|
Percentage of planned immersive virtual reality rehabilitation sessions that were delivered. Calculated as the number of sessions delivered divided by the total number of sessions planned across enrolled participants, multiplied by 100. |
Throughout the 12-session intervention period (approximately 4 weeks per participant).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Upper-Limb Motor Impairment - Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
大体时间：Baseline (before intervention) and after session 12 (approximately 4 weeks).
|
Change in upper-limb motor impairment assessed using the FMA-UE. The motor function subscale ranges from 0 to 66, with higher scores indicating better upper-limb motor performance. Changes from baseline to the post-intervention assessment will be examined. |
Baseline (before intervention) and after session 12 (approximately 4 weeks).
|
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Independence in Activities of Daily Living - Barthel Index(BI)
大体时间：Baseline (before intervention) and after session 12 (approximately 4 weeks).
|
Change in independence in basic activities of daily living assessed using the BI. Total scores range from 0 to 100, with higher scores indicating greater functional independence. Changes from baseline to the post-intervention assessment will be examined. |
Baseline (before intervention) and after session 12 (approximately 4 weeks).
|
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User Satisfaction - User Satisfaction Evaluation Questionnaire (USEQ)
大体时间：After session 1, after session 6 (approximately 2 weeks), and after session 12 (approximately 4 weeks).
|
Participant-reported satisfaction and user experience with immersive virtual reality, assessed using the USEQ. Responses are rated on a five-point Likert scale, with higher scores on positively worded items indicating greater satisfaction. Discomfort-related items are interpreted separately. |
After session 1, after session 6 (approximately 2 weeks), and after session 12 (approximately 4 weeks).
|
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Simulator Sickness Symptoms - Simulator Sickness Questionnaire (SSQ)
大体时间：After session 1, after session 6 (approximately 2 weeks), and after session 12 (approximately 4 weeks).
|
Symptoms associated with virtual reality exposure, including nausea, oculomotor discomfort, and disorientation, assessed using the SSQ. Higher scores indicate greater symptom severity. |
After session 1, after session 6 (approximately 2 weeks), and after session 12 (approximately 4 weeks).
|
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Rehabilitation Participation - Pittsburgh Rehabilitation Participation Scale (PRPS)
大体时间：During each intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
Therapist-rated participation during immersive virtual reality rehabilitation sessions, assessed using the PRPS. Scores range from 1 to 6, with higher scores indicating greater participation. |
During each intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Documented Gameplay Duration
大体时间：During each delivered intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
Duration of active immersive virtual reality gameplay, recorded in minutes during each intervention session. Descriptive statistics will summarize the documented gameplay duration across delivered sessions. |
During each delivered intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
|
Technical Interruptions
大体时间：During each delivered intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
Number and proportion of delivered immersive virtual reality sessions affected by technical interruptions, including headset tracking problems, controller connectivity issues, or signal loss. |
During each delivered intervention session (sessions 1-12), over approximately 4 weeks per participant.
|
|
Adverse Events
大体时间：From the first intervention session through completion of session 12, approximately 4 weeks per participant.
|
Number and description of adverse events documented during the immersive virtual reality intervention, including symptoms or incidents potentially associated with virtual reality exposure. Events will be summarized descriptively. |
From the first intervention session through completion of session 12, approximately 4 weeks per participant.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- DUTH-IVR-STROKE-2025-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The individual participant data generated during this study will not be publicly shared due to participant confidentiality considerations and the small sample size. Aggregated study findings will be reported in the resulting publications.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.