RGS@Home: Personalized 24/7 Home Care Post-stroke
- Conditions
- Stroke, AcuteHemiparesis;Poststroke/CVASpasticity, MuscleMotor Disorders
- Interventions
- Behavioral: Therapy as usualDevice: RGS based training and monitoring
- Registration Number
- NCT04620707
- Lead Sponsor
- Institute for Bioengineering of Catalonia
- Brief Summary
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. Market drivers exist for new ICT based treatment solutions. IBEC/ Eodyne Systems has developed and commercialised 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 showing its superiority over other products while reducing cost also through its use of standard off-the-shelf hardware and a Software as a Service model (SaaS). Commercial evaluations have shown that RGS acts as a workforce multiplier while delivering a high quality of care at clinical centres (RGS@Clinic). However, in order to achieve significant benefits in the patients' QoL, it is essential that RGS becomes an at home solution providing 24/7 monitoring and care. For this reason, this project aims at investigating the RGS acceptability and adoption model.
The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerate the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as usual Therapy as usual - RGS based therapy RGS based training and monitoring -
- Primary Outcome Measures
Name Time Method 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 weeks. Change in score from baseline to end of treatment (12 weeks).
- Secondary Outcome Measures
Name Time Method Number of patients that are readmitted into the hospital (inpatient) after being discharged to at-home status. 12 months. Number of patients from baseline to 12 months post-baseline.
Change in the SIS (Stroke impact Scale) [min=0, max=42]. Higher scores indicate better functioning. 12 months. Change in score from baseline to follow-up (12 months).
Change in the Hamilton Scale Depression [min=0, max=52]. Lower scores indicate less impairment. 12 months. Change in score from baseline to follow-up (12 months).
Change in the Ashworth Scale [min=0, max=4]. Lower scores indicate less impairment. 12 months. Change in score from baseline to follow-up (12 months).
Change in Barthel Index [min=0, max=100]. Higher scores indicate better functioning. 12 months. Change in score from baseline to end of treatment (12 months).
Change in the Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment. 12 weeks. Change in score from baseline to end of treatment (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 score from baseline to follow-up (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 score from baseline to follow-up (12 months).
Change in the Fatigue Severity Scale [min=9, max=63]. Higher scores indicate more fatigue. 12 months. Change in score from baseline to follow-up (12 months).
Change in the Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing. 12 months. Change in score from baseline to follow-up (12 months).
Trial Locations
- Locations (1)
Institute for Bioengineering of Catalonia - Specs Lab
🇪🇸Barcelona, Spain