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

N/ACompletedNCT04620707

Institute for Bioengineering of Catalonia52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

RGS based training and monitoringDEVICE

The RGS treatment will consist in a variable number of sessions per week of RGS-based training. Each session consists of cognitive and motor training involving reaching, grasping, placing virtual objects. The duration of the training period will be variable. Patients will use the RGS@Clinic from admission to discharge, and will have the RGS@Home during the first 3 months of the outpatient stage after recruitment. After this period of time, the patient will be evaluated by clinicians and the RGS@Home system will be collected. The RGS-Wear will be kept by the patient also during the follow-up period, up to 1 year post-recruitment.

Therapy as usualBEHAVIORAL

The patients will follow treatment as usual, including conventional rehabilitation and physical therapy when corresponding. The exact treatment that the patients will receive will depend on the local medical guidelines.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.

Changes from baseline to end of treatment (12 weeks)

Time frame: 12 weeks

Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.

Changes from baseline to follow up (6 months)

Time frame: 6 months

Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.

Changes from baseline to follow up (12 months)

Time frame: 12 months

Secondary Outcomes

Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.

Change in score from baseline to end of treatment (12 weeks)

Time frame: 12 weeks

Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.

Change in score from baseline to follow-up (6 months)

Time frame: 6 months

Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.

Change in score from baseline to follow-up (12 months)

Time frame: 12 months

CAHAI [min=13, max=91]. Higher scores indicate better functioning.

Change in score from baseline to the end of treatment and follow-up

Time frame: 12 weeks

CAHAI [min=13, max=91]. Higher scores indicate better functioning.

Change in score from baseline to the end of treatment and follow-up

Time frame: 12 months

Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow up

Time frame: 12 weeks

Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow up

Time frame: 12 months

Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.

Change in score from baseline to end of treatment and follow up.

Time frame: 12 weeks

Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.

Change in score from baseline to end of treatment and follow up.

Time frame: 12 months

Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow up

Time frame: 12 weeks

Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow up

Time frame: 12 months

Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow-up

Time frame: 12 weeks

Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.

Change in score from baseline to end of treatment and follow-up

Time frame: 12 months

Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.

Change in score from baseline to end of treatment and follow-up

Time frame: 12 weeks

Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.

Change in score from baseline to end of treatment and follow-up

Time frame: 12 months

Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.

Change in score from baseline to end of treatment and follow up

Time frame: 12 weeks

Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.

Change in score from baseline to end of treatment and follow up

Time frame: 12 months

Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.

Change in score from baseline to end of treatment and follow up

Time frame: 12 weeks

Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.

Change in score from baseline to end of treatment and follow up

Time frame: 12 months

Number of participants readmitted to the hospital after being discharged to at-home status.

Number of patients from baseline to 12 months post-baseline.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes