RGS@Home Project: Scaling ICT Based Neurorehabilitation to Personalized 24/7 Home Care Post-stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Change in the score of the upper extremity section of the Fugl-Meyer Assessment Test [min=0, max=66]. Higher scores indicate better functioning.
研究概览
简要总结
Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, the healthcare systems are not able to respond to the current demand let alone its future increase. There is a need to deploy new approaches that advance current rehabilitation methods and enhance their efficiency.
One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices such as the Rehabilitation Gaming System (RGS), a science-based ICT solution for neurorehabilitation combining brain theory, AI, cloud computing and virtual reality and targeting motor and cognitive recovery after stroke. RGS provides a continuum of evaluations and therapeutic solutions that accompany the patient from the clinic to the therapy centre. RGS has been clinically validated. However, in order to achieve significant benefits in the patients' QoL, it is essential that this technological solution becomes an at home solution providing training and 24/7 monitoring and care. For this reason, this project aims at investigating not only its clinical validity but also the RGS acceptability and adoption model. The findings derived from this study will contribute to establish a novel neurorehabilitation paradigm that can accelerate the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting a first-ever ischemic or intracerebral hemorrhagic stroke.
- •A CT SCAN and/or MRI had exclude other pathologies.
- •Lesion localization by clinical symptoms/signs.
- •Moderate to mild proximal upper limb motor impairment (MRC≥2).
- •Age 20-85 years old.
- •Able to sit on a chair or a wheelchair interacting with the RGS during a full session, and be capable and willing to participate in RGS therapy.
排除标准
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •Severe cognitive capabilities that prevent the execution of the experiment (MoCA < 19). This cut-off score is based on pilot study (Maier, M. et al, 2019).
- •Arteriovenous malformation or lesions not related with a stroke.
- •Severe associated impairment such as spasticity, communication disabilities (sensorial, Wernicke aphasia or apraxia), major pain or other neuromuscular impairments or orthopedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale < 3).
- •Unable to use the RGS independently according to the therapist's observations and lacking support from a caregiver to use the RGS.
- •Refusal to sign the consent form.
- •Pre-stroke history of upper limb motor disability.
研究组 & 干预措施
RGS based therapy
干预措施: RGS based training and monitoring (Device)
Treatment as usual
干预措施: Therapy as usual (Behavioral)
结局指标
主要结局
Change in the score of the upper extremity section of the Fugl-Meyer Assessment Test [min=0, max=66]. Higher scores indicate better functioning.
时间窗: 12 weeks.
Change in score from baseline to end of treatment (12 weeks).
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
时间窗: 12 weeks
Changes from baseline to end of treatment (12 weeks)
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
时间窗: 6 months
Changes from baseline to follow up (6 months)
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
时间窗: 12 months
Changes from baseline to follow up (12 months)
次要结局
- Number of patients that are readmitted into the hospital (inpatient) after being discharged to at-home status.(12 months.)
- Change in the SIS (Stroke impact Scale) [min=0, max=42]. Higher scores indicate better functioning.(12 months.)
- Change in the Hamilton Scale Depression [min=0, max=52]. Lower scores indicate less impairment.(12 months.)
- Change in the Ashworth Scale [min=0, max=4]. Lower scores indicate less impairment.(12 months.)
- Change in Barthel Index [min=0, max=100]. Higher scores indicate better functioning.(12 months.)
- Change in the Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.(12 weeks.)
- Change in the score of the upper extremity section of the Fugl-Meyer Assessment Test. [min=0, max=66]. Higher scores indicate better functioning.(12 months.)
- Change in the Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.(12 months.)
- Change in the Fatigue Severity Scale [min=9, max=63]. Higher scores indicate more fatigue.(12 months.)
- Change in the Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.(12 months.)
- Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.(12 weeks)
- Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.(6 months)
- Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.(12 months)
- CAHAI [min=13, max=91]. Higher scores indicate better functioning.(12 weeks)
- CAHAI [min=13, max=91]. Higher scores indicate better functioning.(12 months)
- Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.(12 weeks)
- Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.(12 months)
- Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.(12 weeks)
- Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.(12 months)
- Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.(12 weeks)
- Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.(12 months)
- Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.(12 weeks)
- Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.(12 months)
- Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.(12 weeks)
- Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.(12 months)
- Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.(12 weeks)
- Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.(12 months)
- Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.(12 weeks)
- Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.(12 months)
- Number of participants readmitted to the hospital after being discharged to at-home status.(12 months)
研究者
Anna Mura
Senior Fellow
Institute for Bioengineering of Catalonia