AggRegated System of SensOrs and Multimedia Monitors: Technology for InnovAtion and PersonalizaTion of REhabilitation Care. (ROOMMATE) (ROOMMATE)

ROOMMATE - AggRegated System of SensOrs and Multimedia Monitors: Technology for InnovAtion and PersonalizaTion of REhabilitation Care.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subacute Stroke; Stroke; Subacute
• Intervention / Treatment: Other: Active Comparator: Conventional rehabilitation (Group A); Device: ROOMMATE 1st; Device: ROOMMATE 2nd

Detailed Description

Study Procedures

The study involves three successive phases:

Phase 1 During the first phase, after obtaining Ethics Committee approval, Living Labs will be planned. In these sessions, end users will test the proposed solutions and provide feedback on acceptability and usability. This phase is critical for defining user and system requirements. Additionally, health professionals will be trained as system coaches to support patients and their families in the subsequent phases.

The coaches will be selected from health professionals (physical therapists, occupational therapists, speech therapists, psychologists, nurses) with at least three professionals per center. They will complete a one-week course in digital literacy (e-literacy), covering:

• Technical and operational skills for managing and using digital technologies.
• Information and navigation skills.
• Specific training on the use of the Khymeia Home Kit.
• Training on using the inertial sensors developed by UNIFI. The training will conclude with a written and practical exam.

Subsequently, a multicenter multiple cohort RCT (cmRCT) will be conducted, consisting of two trials:

1. A first RCT (Phase 2 of the study).
2. A second pilot RCT (Phase 3 of the study). The study will be carried out in an inpatient setting for individuals with subacute stroke outcomes at the two clinical centers: IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and Elias University Emergency Hospital in Bucharest, Romania.

The cmRCT design was chosen to address some limitations of traditional RCTs, such as issues with recruitment, ethics, patient preferences, and treatment comparison. Moreover, the cmRCT allows the simultaneous evaluation of different interventions.

In ROOMMATE, eligible patients who consent to baseline (T0) and final (T1, three weeks later) assessments may also be offered an additional intervention, forming the ROOMMATE Study Cohort. A subset of these patients will be randomized to receive an offer to participate in the ROOMMATE Interventions (B or B1), while those not randomized will form the control group (A, receiving usual care). This design will allow two successive RCTs to be conducted.

Phase 2

The first RCT will compare usual care (A) with a preliminary version of the ROOMMATE solution (B), which includes:

• Usual care.
• The Khymeia Home Kit monitor.
• Educational and rehabilitative content developed by clinical partners.
• Coaching for technology use. The sample size for this RCT is 140 patients, randomly assigned to Group A or B, with competitive enrollment across the two clinical centers.

The Khymeia Home Kit, supplemented with educational content, can be used by patients alone or with a caregiver. The educational materials will include:

• General information about stroke pathogenesis and prognosis.
• Strategies and advice for managing the condition.
• Health-related content, such as details on daily hospitalization routines, the roles of various care professionals, and discharge management (including bureaucratic aspects).
• Information on local support networks. Additional cognitive and motor rehabilitation content will be developed by a multidisciplinary team and customized by department therapists to match each patient's needs and recovery potential.

The coach will be available in person five days a week to support all end users in using the ROOMMATE technology.

Phase 3

Following the completion of the first RCT, a second pilot RCT with 60 patients will test usual care (A) against a mature version of the ROOMMATE solution (B1). This includes:

• Usual care.
• Motor and cognitive treatment supported by inertial sensor assessment for personalized interventions.
• Integration of clinical assessments with IMU-derived reports.
• Educational and rehabilitative content developed by clinical partners.
• Coaching for technology use. In Group B1, the Khymeia Home Kit (with educational and rehabilitation content) will be enhanced with inertial sensors developed by UNIFI. These sensors will measure hand motility and provide tailored rehabilitation interventions.

The ROOMMATE intervention will last three weeks per patient. During this period:

• Group B patients will receive training in using the technology from the coach.
• Patients and their families will have self-directed or supervised access to HKK features, including educational, rehabilitative, and infotainment content.
• Therapists will recommend the most appropriate content based on the patient's needs.
• In Group B1, the physician will use inertial sensor data to quantify motor deficits and tailor the treatment accordingly.

Assessments (T0 and T1)

At baseline (T0) and post-treatment (T1), the following will be assessed:

• Demographics: Sex, age, education.
• Clinical data: Type of stroke, time since stroke, lesion laterality.
• Primary and secondary outcomes: Disability in ADLs (modified Barthel Index, mBI). Manual dexterity. Upper limb motor skills. Neuropsychological and global cognitive functioning. Anxiety and depression. Quality of life.

At post-treatment (T1), also the following will be assessed:

• Primary and secondary outcomes: Usability, feasibility, and social impact measures. User experience and education evaluation. Wearability of sensors. Social impact and patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca Cecchi; Phone Number: +39 3388627184; Email: fcecchi@dongnocchi.it
• Study Contact Backup: Name: Stefano Doronzio; Phone Number: +39 3924685537; Email: sdoronzio@dongnocchi.it

Study Locations

• Italy
  • Florence, Italy
    • IRCCS Fondazione Don Carlo Gnocchi ONLUS
    • Contact: Francesca Cecchi, Associate Professor; Phone Number: +39 3388627184; Email: fcecchi@dongnocchi.it
    • Contact: Stefano Doronzio, PT, Phds; Phone Number: +39 3924685537; Email: sdoronzio@dongnocchi.it
    • Contact: Francesca Cecchi, Associate Professor
    • Contact: Stefano Doronzio, PT, Phds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• presence of signs of clinical instability, defined by a score greater than zero on the Clinical Instability Scale (SIC).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional rehabilitation (Group A); The first 140 patients who meet the inclusion criteria will be randomized between this group and group B. This group will undergo conventional therapy.	Other: Active Comparator: Conventional rehabilitation (Group A); The 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.
Experimental: ROOMMATE 1st (Group B); The 70 patients randomized to this group will undergo conventional treatment and, in addition, will have the first version of the ROOMMATE system.	Device: ROOMMATE 1st; In 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.
Experimental: ROOMMATE 2nd (Goup B2); Group B2 will undergo conventional treatment and will have an extended version of the bedside multimedia monitor apparatus, integrated with an inertial sensor to enable the serious games on the experimental platform.	Device: ROOMMATE 2nd; Once 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Barthel index (mBI)	Assessment of disability in ADLs, scoring 0-100	baseline, 3 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test	Manual Dexterity, evaluated in seconds	baseline, 3 week
Fugl Meyer Assessment (FMA)	Upper limb motor skills, scoring 0 - 126	baseline, 3 week
Functional Ambulation Category (FAC)	functional ambulation assessment, scoring 0-5	baseline, 3 week
Montreal Cognitive Assessment (MOCA)	Cognitive impairment assessment, scoring 0 - 30	baseline, 3 week
Short Form 12 item	generic assessment of quality of life, scoring 0-47	baseline, 3 week
Training-Evaluation-Inventory (TEI)	evaluation of the course and its contents, a 45 item scale scoring with a 5 point likert scale	3 week
Short Version of the User Experience Questionnaire (UEQ-S)	user expirience assessment, 8 item scale scoring with a 7 point likert scale	3 week
Final Measurement Scales for Perceived Usefulness and Perceived Ease of Use	Acceptance Assessment of the ROOMATE sistem, a 12 item scale scoring with a 7 point likert scale	3 week
HUBBI - eHealth UsaBility Benchmarking Instrument	Usability Assessment of the ROOMATE sistem, a 18 item scale scoring with a 5 point likert scale	3 week
Hearts Test	3-minute visual attention barrage test, scores 0-50	baseline, 3 week
we wearability test	Sensors Wearability Assessment, likert scale, scores 1-5	3 week
Motricity Index	Upper limb and lower limb motor skills, scoring 0 - 100	baseline, 3 week

Collaborators and Investigators

• Sponsor: Francesca Cecchi
• Collaborators: University of Florence; Carol Davila University of Medicine and Pharmacy; Roessingh Research and Development; MEDEA, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Enriched environment; Neurorehabilitation; Digital health; Continuum of care; subacute stroke; cmRCT; Assistive/rehabilitation robotics; People-centered care; Accessible care; Innovation adoption
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: cmRCT ROOMMATE; Grant Agreement Nº: 101095654. (Other Grant/Funding Number: Tranforming Health and Care Systems partnership)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publishing the results in international congresses and conferences and in impacted journals, the project partners, according to the stipulated data management plan will disseminate the results following the principle of "as open as possible, as closed as needed". Resuls will be shared on a Zenodo-like repository.

IPD Sharing Time Frame

We plan to share:

• preliminary results as the study progresses.
• The study protocol on an international impacted journal upon obtaining ethics committee and the number of registration on clinicaltrials.gov.
• The study results, within two year, at the end of the study

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No