The aim of this clinical trial is to assess whether the ROOMMATE system can effectively support the rehabilitation of adults recovering from subacute strokes. The study will be conducted at the neuromotor rehabilitation inpatient clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and the rehabilitation inpatient unit of Elias University Emergency Hospital in Bucharest, Romania.
Primary Objectives:
-To assess the effects on functional recovery in subacute stroke survivors of a technological rehabilitation station placed at patients' bedsides, combined with dedicated coaching provided to all users (patients, informal caregivers, and formal caregivers).
Secondary Objectives:
* Evaluation of the effects of the experimental treatment on patient satisfaction, upper limb motor skills, manual dexterity, global cognitive functioning, anxiety, and depression. * Assessment of user experience, acceptance, and usability of the technology by patients and caregivers. * Evaluation of social impact using the Social Return on Investment (SROI) ratio of the experimental treatment.
Participants randomized into one of the experimental groups, in addition to receiving conventional care, will use the ROOMMATE system during their hospitalization. The system will be made available to patients and will be free for them to use at their discretion.
The station will include:
Multimedia monitors (Khymeia home kit): These will deliver cognitive and motor serious games, educational and rehabilitative content, as well as infotainment specifically developed by the clinical partners of the project.
An inertial sensor kit: This integrates with the monitors to guide users through virtual reality environments.
outcome of ischemic or hemorrhagic stroke in subacute phase (< 3 months after the event)
willingness to participate in the project, with informed consent signed by the subject or, when necessary, by the support administrator.
severe visual and/or auditory impairments that cannot be corrected
severe cognitive and/or speech impairments that interfere with the ability to use the HKK system and the SensoMode accessory independently and/or in the
absence of a caregiver who can assist the patient in using the system;
skin lesions that prevent wearing the inertial sensors;
Parallel
Active Comparator: Conventional rehabilitation (Group A)
Other interventionThe conventional group will undergo standard rehabilitation treatment according to the rehabilitation plan developed by the rehabilitation team. This group will undergo 3 hours of rehabilitation per day and will carry out face-to-face rehabilitation following an impairment-based approach aimed at the treatment of motor-cognitive functions.
ROOMMATE 1st
DeviceIn addition to Group A, this group will have the bedside multimedia monitor apparatus to access informative, rehabilitation, and entertainment content. Additionally, this group will have a digital and innovation coach to receive support in using the technology.
ROOMMATE 2nd
DeviceOnce the first RCT of the cmRCT is completed, a pilot RCT will be initiated, randomizing 60 cases between Group A and this group. In addition to conventional treatment, this group will have a version of the ROOMMATE system integrated with inertial sensors worn on the hands and fingers to guide the serious games on the platform.
modified Barthel index (mBI)
Assessment of disability in ADLs, scoring 0-100
Nine Hole Peg Test
Manual Dexterity, evaluated in seconds
Fugl Meyer Assessment (FMA)
Upper limb motor skills, scoring 0 - 126
Functional Ambulation Category (FAC)
functional ambulation assessment, scoring 0-5
Montreal Cognitive Assessment (MOCA)
Cognitive impairment assessment, scoring 0 - 30
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Francesca Cecchi
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
MEDEA, Italy
Collaborator
Carol Davila University of Medicine and Pharmacy
Collaborator
Roessingh Research and Development
Collaborator
University of Florence
Collaborator
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