StrokeNCT04620707

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

A study testing RGS based training and monitoring and Therapy as usual in people with Stroke and Hemiparesis, run by Institute for Bioengineering of Catalonia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Stroke, Hemiparesis, Subacute Stroke
What is being tested?: RGS based training and monitoring and Therapy as usual
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteSpain
Study dates: 9 Nov 2020to 4 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University Miguel Hernandez - Specs Lab
Elche, Alicante, 03202

Other trials in Spain

About this study

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

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.

Conditions: Stroke, Hemiparesis, Subacute Stroke, Chronic Stroke
Being tested: RGS based training and monitoring, Therapy as usual
Keywords: Stroke, Fatigue, Rehabilitation, Personalization, eHealth
Medical subject headings: Stroke, Paresis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 usualBehavioural
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.

Study groups in NCT04620707
Study group	Role	What they receive
RGS based therapy	Experimental	Not described Receives: Device: RGS based training and monitoring
Treatment as usual	Active comparator	Not described Receives: Behavioral: Therapy as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
Changes from baseline to end of treatment (12 weeks)
Measured: 12 weeks
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
Changes from baseline to follow up (6 months)
Measured: 6 months
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
Changes from baseline to follow up (12 months)
Measured: 12 months

Secondary outcomes (20)

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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 20204 Aug 2023

First posted9 Nov 2020
Study start9 Nov 2020
Primary completion4 Aug 2023
Study completion4 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04620707
Sponsor's protocol ID: RGS@Home2020
Status last verified: Nov 2021
First submitted: 3 Nov 2020
Last updated: 3 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mura A, Maier M, Ballester BR, De la Torre Costa J, Lopez-Luque J, Gelineau A, Mandigout S, Ghatan PH, Fiorillo R, Antenucci F, Coolen T, Chivite I, Callen A, Landais H, Gomez OI, Melero C, Brandi S, Domenech M, Daviet JC, Zucca R, Verschure PFMJ. Bringing rehabilitation home with an e-health platform to treat stroke patients: study protocol of a randomized clinical trial (RGS@home). Trials. 2022 Jun 20;23(1):518. doi: 10.1186/s13063-022-06444-0.
PubMed 35725616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RGS@Home Project: Scaling ICT Based Neurorehabilitation to Personalized 24/7 Home Care Post-stroke
ClinicalTrials.gov ID: NCT04620707
Acronym / sponsor ID: RGS@Home2020
Conditions: Stroke, Hemiparesis, Subacute Stroke, Chronic Stroke
Keywords: Stroke, Fatigue, Rehabilitation, Personalization, eHealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Institute for Bioengineering of CataloniaUniversity, hospital or other
Collaborators: Universidad Miguel Hernández de Elche.
Study start: 9 Nov 2020 (actual)
Primary completion: 4 Aug 2023 (actual)
Study completion: 4 Aug 2023 (actual)
First posted: 9 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RGS based therapy	Experimental	Device: RGS based training and monitoring
Treatment as usual	Active comparator	Behavioral: Therapy as usual

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RGS based training and monitoringThe 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.	Device	RGS based therapy
Therapy as usualThe 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.	Behavioural	Treatment as usual

Primary outcome

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)
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
Time frame: 6 months
Changes from baseline to follow up (6 months)
Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning.
Time frame: 12 months
Changes from baseline to follow up (12 months)

20 secondary outcomes

Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.
Time frame: 12 weeks
Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.
Time frame: 6 months
Fugl-Meyer Upper Extremities (FM-UE) [min=0, max=66]. Higher scores indicate better functioning.
Time frame: 12 months
CAHAI [min=13, max=91]. Higher scores indicate better functioning.
Time frame: 12 weeks
CAHAI [min=13, max=91]. Higher scores indicate better functioning.
Time frame: 12 months
Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.
Time frame: 12 weeks
Hamilton Depression Scale [min=0, max=52]. Lower scores indicate less impairment.
Time frame: 12 months
Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.
Time frame: 12 weeks
Fatigue Severity Scale (FSS) [min=9, max=63]. Higher scores indicate more fatigue.
Time frame: 12 months
Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.
Time frame: 12 weeks
Visual Analogue Score (VAS) [min=0, max=10]. Lower scores indicate less impairment.
Time frame: 12 months
Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.
Time frame: 12 weeks
Modified Ashworth Scale (MAS) [min=0, max=4]. Lower scores indicate less impairment.
Time frame: 12 months
Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.
Time frame: 12 weeks
Stroke Impact Scale (SIS) [min=0, max=42]. Higher scores indicate better functioning.
Time frame: 12 months
Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.
Time frame: 12 weeks
Stroke Specific Quality Of Life scale (SS-QOL) [min=49, max=245]. Higher scores indicate better functioning.
Time frame: 12 months
Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.
Time frame: 12 weeks
Wellbeing questionnaire (SF-36) [min=0, max=100]. Higher scores indicate more wellbeing.
Time frame: 12 months
Number of participants readmitted to the hospital after being discharged to at-home status.
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Derived from this study: PubMed 35725616Mura A, Maier M, Ballester BR, De la Torre Costa J, Lopez-Luque J, Gelineau A, Mandigout S, Ghatan PH, Fiorillo R, Antenucci F, Coolen T, Chivite I, Callen A, Landais H, Gomez OI, Melero C, Brandi S, Domenech M, Daviet JC, Zucca R, Verschure PFMJ. Bringing rehabilitation home with an e-health platform to treat stroke patients: study protocol of a randomized clinical trial (RGS@home). Trials. 2022 Jun 20;23(1):518. doi: 10.1186/s13063-022-06444-0.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RGS based training and monitoring and Therapy as usual in people with Stroke and Hemiparesis, run by Institute for Bioengineering of Catalonia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barthel Index (BI) [min=0, max =100]. Higher scores indicate better functioning. (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04620707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.