protocolSection identificationModule nctId: NCT06374927, orgStudyIdInfo id: PHRASE-2023, briefTitle: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study, acronym: PHRASE-2023, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Donders Centre for Neuroscience, class: OTHER, descriptionModule briefSummary: The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientiﬁc principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation Gaming System (VR-based mobile application), outcomesModule primaryOutcomes measure: Usability, primaryOutcomes measure: User experience, primaryOutcomes measure: Adherence, primaryOutcomes measure: Acceptance, secondaryOutcomes measure: The Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE), secondaryOutcomes measure: Hamilton Depression Rating Scale (HDRS), secondaryOutcomes measure: Fatigue Severity Scale (FSS), secondaryOutcomes measure: Pain Visual Analogue Scale (VAS), secondaryOutcomes measure: Barthel Index (BI), secondaryOutcomes measure: EuroQol - 5 Dimension - 5 Level (EQ-5D-5L), secondaryOutcomes measure: Modified Ashworth scale (MAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier universitaire de Limoges, status: NOT_YET_RECRUITING, city: Limoges, zip: 87000, country: France, contacts name: Stephane Mandigout, Dr., role: CONTACT, email: stephane.mandigout@unilim.fr, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Cluj Rehabilitation Hospital, status: NOT_YET_RECRUITING, city: Cluj-Napoca, state: Cluj, zip: 400066, country: Romania, contacts name: Stefan Strilciuc, PhD., role: CONTACT, email: stefan.strilciuc@genomics-center.ro, geoPoint lat: 46.76667, lon: 23.6, locations facility: Parc Sanitari Sant Joan de Déu, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Raffaele Fiorillo, Dr., role: CONTACT, email: raffaele.fiorillo@sjd.es, contacts name: Raffaele Fiorillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: IRF La Salle, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Miguel Gómez Martínez, Dr., role: CONTACT, email: miguel.gomez@lasallecampus.es, contacts name: Miguel Gómez Martínez, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False