临床试验雷达

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.

The rapid growth in the number of stroke patients needing care and rehabilitation requires an urgent scientifically grounded, and scalable response. 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. The PHRASE project combines theoretical neuroscience, and intervention protocols based on VR AR technology, the RGS, making it an excellent alternative to solving cognitive training.

The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, including the user experience, adherence, and acceptance of the PHRASE system.

Specifically, the patient interacts with the RGSapp, a mobile app system that through the mobile registers the patient's movements and performance during the tasks to evaluate, reassess and update training protocols through AI-based algorithms. The clinicians have access to MIMS (Medical Information Management System) a portal that allows them to manage the patient profiles and deliver precise and objective metrics of the performance of the patient together with dashboards for therapists and clinicians. It facilitates diagnostics, monitoring, intervention scheduling, data storage and analytics, and reports and patient management.

The primary objective of this study is to measure the usability, adherence, user experience and acceptance of the PHRASE system during a six-week intervention.

Secondary outcome parameters will be assessed with clinical scales to explore the effectiveness of performing motor and cognitive assessments online and cognitive treatments provided through the RGSapp technology.

Investigators hypothesize that the personalized training supported by the PHRASE system is:

1. Highly accepted by patients and clinicians. More specifically, it is expected that this approach to show good user experience and usability by the patients and ease patients' management by the clinicians.
2. It increases the frequency and time spent with the rehabilitation program. More specifically, it is expected this approach shows good adherence to treatment.
3. Explore the impact of the PHRASE system on cognitive assessment, function impairment, and quality of life.

STUDY DESIGN AND POPULATION: The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, the user experience, the adherence, and the acceptance of the PHRASE system. Each clinical site will include 30-50 stroke patients (in any stroke stage), minimum age of 18 years. Over six weeks, the participants will integrate the PHRASE system into their daily routines, running parallel to their regular neurorehabilitation treatment.

STUDY SETTING: The study will be conducted in parallel in different European hospitals. The experimentation involves 3 different phases: Baseline assessment (T0) before the start of the trial, remote assessment (T1) and Final evaluation (T2) at the end of the trial, after 6 weeks.