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NCT06374927Recruiting

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

Donders Centre for NeuroscienceClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Stroke
Drug/Device/Intervention
Rehabilitation Gaming System (VR-based mobile application)
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Donders Centre for Neuroscience
Location
Limoges,Cluj-Napoca,Barcelona,Madrid, France,Romania,Spain
Timeline & enrollment
Phase
N/A
Start date
Apr 25, 2024
End date
Oct 30, 2024
Enrollment
150 participants
Primary outcome

Usability,User experience,Adherence,Acceptance

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.

ICD-10 classifications
Stroke, not specified as haemorrhage or infarctionSequelae of stroke, not specified as haemorrhage or infarctionCerebral infarctionFamily history of strokeCerebral infarction, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06374927
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06374927 through Pure Global AI's free database. This phase not specified trial is sponsored by Donders Centre for Neuroscience and is currently Recruiting. The study focuses on Stroke. Target enrollment is 150 participants.

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