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

NCT06374927 | Recruiting

• 1 other identifier: PHRASE-2023
• Study Type: observational
• Target: 150
• Locations: 3 countries
• Sites: 4

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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Virtual Reality (VR); Augmented Reality (AR)

Outcome Measures

Primary Outcomes (4)

• Usability

  Usability will be assessed at T2 by the System Usability Scale (SUS): The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from 'Strongly agree' to 'Strongly disagree'.

  Week 6

• User experience

  User experience will be assessed at T2 by the User Experience Questionnaire (UEQ): the scales of the questionnaire cover a comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience aspects (originality, stimulation) are measured.

  Week 6

• Adherence

  Adherence will be assessed by the total time the RGSapp is used, in comparison to the advised RGSapp sessions for the entire duration of the study. Via the user ID, it is possible to monitor the patient's access to the RGSapp and the hours trained.

  Week 6

• Acceptance

  Acceptance will be assessed at T2 by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the instrument is a self-administered questionnaire assessing user satisfaction with assistive technology products and associated services.

  Week 6

Secondary Outcomes (8)

• The Montreal Cognitive Assessment (MoCA)

  Baseline, Week 6

• Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE)

  Baseline, Week 6

• Hamilton Depression Rating Scale (HDRS)

  Baseline, Week 6

• Fatigue Severity Scale (FSS)

  Baseline, Week 6

• Pain Visual Analogue Scale (VAS)

  Baseline, Week 6

Study Arms (1)

Stroke patients

Stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years.

Device: Rehabilitation Gaming System (VR-based mobile application)

Interventions

Rehabilitation Gaming System (VR-based mobile application) DEVICE

The study intervention includes using the mobile phone technology RGSapp. This application integrates sensor data for delivering patient-tailored VR and AR-based training via gamified exercises for cognitive training.

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients at different time points after stroke (acute, subacute, and chronic).

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Donders Centre for Neuroscience: lead

Study Sites (4)

Centre hospitalier universitaire de Limoges

Limoges, 87000, France

NOT YET RECRUITING

Cluj Rehabilitation Hospital

Cluj-Napoca, Cluj, 400066, Romania

NOT YET RECRUITING

Parc Sanitari Sant Joan de Déu

Barcelona, Spain

RECRUITING

IRF La Salle

Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Paul Verschure, PhD

CONTACT

31-631132710; paul.verschure@ru.nl

Anna Mura

CONTACT

anna3.mura@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Party

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 25, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 30, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

ES (2); FR (1); RO (1)