Clinical trial NCT06374927: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study
Official title: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Virtual Reality (VR)
Augmented Reality (AR)
Lead sponsor: Donders Centre for Neuroscience
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients at different time points after stroke (acute, subacute, and chronic).

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients presenting an ischemic or intracerebral haemorrhagic stroke
2. Age \> 18 years old
3. Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).
4. Lesion localisation by clinical symptoms/signs.
5. Able to sit on a chair or a wheelchair to interact with the RGS system.
6. Minimal experience with smartphone technology based on the clinician's opinion
7. Willing to participate and agree to comply with the trial scheme and procedures
8. Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.

Exclusion Criteria:

1. 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.
2. Severe cognitive capabilities that prevent the execution of the experiment, either evaluated by the MoCA \< 19 or based on the clinician's opinion.
3. Arteriovenous malformation or lesions not related to a stroke.
4. Severe associated impairments such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain, or other neuromuscular impairments.
5. Pre-stroke history of upper limb motor disability.
6. Unable to use the RGS independently according to the clinician's observations and lacking support from a caregiver to use the RGS.
7. Refusal to sign the consent form.
8. No experience with smartphone technology or based on the clinician's opinion.

Primary outcomes:
measure: Usability
timeFrame: Week 6
measure: User experience
timeFrame: Week 6
measure: Adherence
timeFrame: Week 6
measure: Acceptance
timeFrame: Week 6
Secondary outcomes:
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, Week 6
measure: Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE)
timeFrame: Baseline, Week 6
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Baseline, Week 6
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, Week 6
measure: Pain Visual Analogue Scale (VAS)
timeFrame: Baseline, Week 6
measure: Barthel Index (BI)
timeFrame: Baseline, Week 6
measure: EuroQol - 5 Dimension - 5 Level (EQ-5D-5L)
timeFrame: Baseline, Week 6
measure: Modified Ashworth scale (MAS)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre hospitalier universitaire de Limoges
city: Cluj-Napoca
country: Romania
facility: Cluj Rehabilitation Hospital
state: Cluj
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Déu
city: Madrid
country: Spain
facility: IRF La Salle
Study officials:
References: