Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients presenting an ischemic or intracerebral haemorrhagic stroke

• Age \> 18 years old

• Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).

• Lesion localisation by clinical symptoms/signs.

• Able to sit on a chair or a wheelchair to interact with the RGS system.

• Minimal experience with smartphone technology based on the clinician's opinion

• Willing to participate and agree to comply with the trial scheme and procedures

• Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.

Locations
Other Locations
France
Centre hospitalier universitaire de Limoges
NOT_YET_RECRUITING
Limoges
Romania
Cluj Rehabilitation Hospital
NOT_YET_RECRUITING
Cluj-napoca
Spain
Parc Sanitari Sant Joan de Déu
RECRUITING
Barcelona
IRF La Salle
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
Paul Verschure, PhD
paul.verschure@ru.nl
31-631132710
Backup
Anna Mura
anna3.mura@gmail.com
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 150
Treatments
Stroke patients
Stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years.
Related Therapeutic Areas
Sponsors
Leads: Donders Centre for Neuroscience

This content was sourced from clinicaltrials.gov