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Stroke Rehabilitation Using Extended Reality. (STRIVE)

2026年9月3日 更新者:Värmland County Council, Sweden

Stroke Rehabilitation With Innovative Extended Reality (STRIVE): A Feasibility Study in Clinical Practice

After a stroke, many people experience difficulties with movement, balance, or everyday activities. Rehabilitation is an important part of recovery and can help people regain function and confidence in daily life. However, rehabilitation can sometimes become repetitive, tiring, or difficult to maintain over time.

This research project studies the use of Mixed Reality (MR) in stroke rehabilitation. MR uses special glasses that project digital holograms into the real-world environment. This allows individuals to see and interact with virtual objects while remaining aware of and moving within their actual surroundings. Using MR, people can practice movements and functional activities in a safe, engaging, and interactive way. The holographic exercises can be repeated many times in a structured manner, which is important for recovery after stroke. At the same time, the training can be varied to reduce monotony and maintain motivation.

The exercises can be individually adapted to each person's abilities, rehabilitation goals, and daily condition. The level of difficulty can be adjusted as the person progresses. MR systems can also provide immediate visual and auditory feedback, helping individuals understand their performance and encouraging active participation in their rehabilitation.

The project also focuses on how patients experience this type of training and how it fits into everyday life.

研究概览

地位

尚未招聘

条件

详细说明

Stroke is a leading cause of long-term disability worldwide. Many individuals living with chronic stroke experience persistent impairments in motor function, balance, gait, activities of daily living (ADL), and health-related quality of life. Effective rehabilitation requires intensive, task-specific, and repetitive practice; however, maintaining motivation and adherence to conventional rehabilitation programs can be challenging.

Extended Reality (XR) technologies have emerged as promising tools in rehabilitation. XR-based training can provide structured, repetitive, and individualized exercises while incorporating interactive holographic elements into the rehabilitation process. The exercises can be adapted to each participant's abilities and rehabilitation goals, and the level of difficulty can be adjusted according to individual performance and progression.

The Stroke Rehabilitation with Innovative Extended Reality (STRIVE) program was developed to provide a structured XR-based rehabilitation intervention for individuals with chronic stroke. The intervention utilizes the RehAtt XR system and includes exercises targeting upper extremity function, lower extremity function, balance, gait performance, and functional activities.

The primary aim of this study is to investigate whether XR-based rehabilitation, based on established virtual reality rehabilitation principles, can influence motor function, balance, gait performance, activities of daily living, and health-related quality of life in individuals living with chronic stroke. A secondary aim is to explore participants' experiences of using and training with XR technology and to evaluate the feasibility of implementing the intervention in routine clinical practice.

The study uses a Single-Case Experimental Design (SCED) in which each participant serves as their own control. During the baseline phase, repeated assessments will be conducted without XR training to establish the stability of outcome measures and capture natural variation in performance. The baseline phase will last between 1 and 3 weeks and include a minimum of 5 and a maximum of 9 assessment points. Following baseline, participants will receive XR-based rehabilitation for 5 weeks. Outcome measures will continue to be collected three times per week throughout the intervention phase, with assessments performed prior to each XR training session to explore potential changes in physical function, activity performance, participation, and quality of life. The findings will provide important information regarding the feasibility and potential benefits of XR-based stroke rehabilitation and will inform the design of future larger-scale studies.

研究类型

介入性

注册 (估计的)

9

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Värmland County
      • Torsby、Värmland County、瑞典

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults (≥ 18 years) with a verified stroke diagnosis at least six months ago

    • Sufficient cognitive ability MMES (mini mental state examination) ≥ 23
    • Continued need for rehabilitation
    • Ability to walk at least 10 meters, with or without aids
    • Be able to read, understand and express themselves in the Swedish language.

Exclusion Criteria:

  • • Serious vision problems that would affect the use of XR equipment

    • Other progressive or serious illness such as multiple sclerosis, Parkinson's disease, dementia or cancer
    • People with epilepsy or pacemakers

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:XR-Based Stroke Rehabilitation
Participants will receive XR-based rehabilitation using the RehAtt XR system. The intervention consists of individualized exercises targeting upper extremity function, lower extremity function, balance, gait, and functional activities. Training will be delivered three times per week for five weeks following a baseline phase with repeated assessments. Exercise difficulty will be adjusted according to each participant's abilities, performance, and rehabilitation goals.
Participants will receive XR-based rehabilitation using the RehAtt XR system. The intervention consists of individualized exercises targeting upper extremity function, lower extremity function, balance, gait, and functional activities. Training will be delivered three times per week for five weeks following a baseline phase with repeated assessments. Exercise difficulty will be adjusted according to each participant's abilities, performance, and rehabilitation goals.

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
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
大体时间:Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Assessment of lower extremity motor function following stroke. Scores range from 0 to 34, with higher scores indicating better motor function.
Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Action Research Arm Test (ARAT)
大体时间:Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Assessment of upper extremity activity capacity and manual dexterity. Higher scores indicate better upper limb function.
Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Timed Up and Go Test (TUG)
大体时间:Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Assessment of functional mobility. Time required to stand up from a chair, walk 3 meters, turn, return, and sit down. Shorter times indicate better mobility.
Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
10-Meter Walk Test (10MWT)
大体时间:Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
Assessment of walking speed over a 10-meter distance. Higher walking speed indicates better gait performance.
Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.

次要结果测量

结果测量
措施说明
大体时间
Barthel Index
大体时间:Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
Assessment of independence in activities of daily living. Higher scores indicate greater independence.
Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
RAND-36
大体时间:Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
Assessment of health-related quality of life across multiple domains. Higher scores indicate better perceived health status.
Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.

其他结果措施

结果测量
措施说明
大体时间
Participants' Experiences of XR-Based Rehabilitation
大体时间:End of intervention, 3-month follow-up, and 6-month follow-up.
Semi-structured individual interviews will be conducted to explore participants' experiences of XR-based rehabilitation and changes over time. The interview guide will explore experiences of XR-based rehabilitation, including perceived benefits, challenges, motivation, fatigue, and the impact of the intervention on everyday life.
End of intervention, 3-month follow-up, and 6-month follow-up.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年8月31日

首先提交符合 QC 标准的

2026年9月3日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to ethical and privacy considerations and the small sample size of this study.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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