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

NCT04620707 | Completed

• 1 other identifier: RGS@Home2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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

Keywords

Stroke; Fatigue; Rehabilitation; Personalization; eHealth

Outcome Measures

Primary Outcomes (3)

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

  Changes from baseline to end of treatment (12 weeks)

  12 weeks

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

  Changes from baseline to follow up (6 months)

  6 months

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

  Changes from baseline to follow up (12 months)

  12 months

Secondary Outcomes (20)

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

  12 weeks

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

  6 months

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

  12 months

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

  12 weeks

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

  12 months

Other Outcomes (1)

• Number of falls reported by the participants.

  12 months

Study Arms (2)

RGS based therapy

EXPERIMENTAL

Device: RGS based training and monitoring

Treatment as usual

ACTIVE COMPARATOR

Behavioral: Therapy as usual

Interventions

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.

RGS based therapy

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.

Treatment as usual

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Bioengineering of Catalonia: lead
• Universidad Miguel Hernández de Elche.: collaborator

Study Sites (1)

University Miguel Hernandez - Specs Lab

Elche, Alicante, 03202, Spain

Location

Related Publications (1)

• 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.

  PMID: 35725616 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Fatigue

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Fellow

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: November 9, 2020
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: September 3, 2026

Record last verified: 2021-11

Locations

ES (1)