Skip to main content
OpenTrials
Completed

NCT Number: NCT04620707

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Fatigue Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Subacute Stroke Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Miguel Hernandez - Specs Lab

Elche, Alicante, 03202, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RGS based training and monitoring

Device

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 usual

Behavioral

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.

Primary outcomes

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

    Time frame: 12 weeks

    Changes from baseline to end of treatment (12 weeks)

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

    Time frame: 6 months

    Changes from baseline to follow up (6 months)

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

    Time frame: 12 months

    Changes from baseline to follow up (12 months)

Secondary outcomes

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

    Time frame: 12 weeks

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

Other outcomes

  1. Number of falls reported by the participants.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Institute for Bioengineering of Catalonia

Other

Collaborators

  • Universidad Miguel Hernández de Elche.

Registry information

Official study title

RGS@Home Project: Scaling ICT Based Neurorehabilitation to Personalized 24/7 Home Care Post-stroke

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.