Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEodyne Systems SL
About this trial
This study is a multicentric randomized controlled trial evaluating the effectiveness of digital technology, specifically a smartphone with integrated VR-and AR-based intervention, for at-home rehabilitation after stroke. The study focuses on combined motor and cognitive training for patients in the late subacute and chronic phases post-stroke. The intervention is provided through the Rehabilitation Gaming System application RGSapp, a goal-oriented, first-person virtual reality (VR) and augmented reality (AR) mobile application for upper limb rehabilitation. A total of seventy participants will be randomly assigned (1:1 ratio) to either the RGSapp intervention or conventional therapy/standard of care for six weeks. The primary outcome is motor function improvement (upper limb), assessed using the Action Research Arm Test (ARAT). Secondary outcomes include changes in cognitive function, depression, usability, adherence, validity of remote assessments, and healthcare costs.
Eligibility criteria
Qualifiers
Patients presenting an ischemic or intracerebral haemorrhagic stroke, ≥ 3 months post-stroke.
Age > 18 years old
Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC >2).
ARAT: <50, inclusive, to avoid ceiling effects while allowing room for improvement.
Disqualifiers
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 study, evaluated by the MoCA < 19 or based on the clinician's opinion.
Pre-stroke history of upper limb motor disability.
Unable to use the RGS independently, according to the clinician's observations, and needing more support from a caregiver to use the RGS.
Trial design
Treatments tested in this trial
- RGS
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov