RGS@Home: Personalized 24/7 Home Care Post-stroke

Institute for Bioengineering of Catalonia

Status

Unknown

Conditions

Spasticity, Muscle

Hemiparesis;Poststroke/CVA

Motor Disorders

Stroke, Acute

Treatments

Behavioral: Therapy as usual

Device: RGS based training and monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04620707

RGS@Home2020

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.