AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care. (ROOMMATE)

NCT06728020 | Not Yet Recruiting

• 2 other identifiers: cmRCT ROOMMATEGrant Agreement Nº: 101095654.
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subacute Stroke; Stroke; Subacute

Keywords

subacute stroke; Neurorehabilitation; Assistive/rehabilitation robotics; Digital health; Continuum of care; People-centered care; Accessible care; Innovation adoption; cmRCT; Enriched environment

Outcome Measures

Primary Outcomes (1)

• modified Barthel index (mBI)

  Assessment of disability in ADLs, scoring 0-100

  baseline, 3 week

Secondary Outcomes (12)

• Nine Hole Peg Test

  baseline, 3 week

• Fugl Meyer Assessment (FMA)

  baseline, 3 week

• Functional Ambulation Category (FAC)

  baseline, 3 week

• Montreal Cognitive Assessment (MOCA)

  baseline, 3 week

• Hearts Test

  baseline, 3 week

Study Arms (3)

Conventional rehabilitation (Group A)

ACTIVE COMPARATOR

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)

ROOMMATE 1st (Group B)

EXPERIMENTAL

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

ROOMMATE 2nd (Goup B2)

EXPERIMENTAL

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

Interventions

Active Comparator: Conventional rehabilitation (Group A) OTHER

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.

Conventional rehabilitation (Group A)

ROOMMATE 1st DEVICE

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.

ROOMMATE 1st (Group B)

ROOMMATE 2nd DEVICE

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.

ROOMMATE 2nd (Goup B2)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Francesca Cecchi: lead
• MEDEA, Italy: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator
• Roessingh Research and Development: collaborator
• University of Florence: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi Onlus

Florence, Florence, Italy

Location

Related Publications (1)

• Doronzio S, Jansen-Kosterink S, Tesi M, Castagnoli C, Pedrini C, Ciapetti T, De Marco M, Piazzini M, Giacani J, Ciobanu I, Berteanu M, Fiorini L, Rovini E, Cavallo F, Agnoloni F, Baccini M, Cecchi F. Development of a cohort multiple randomized clinical trial to test an integrated system of sensors and multimedia monitors technology, for stroke rehabilitation: the ROOMMATE study protocol. Front Neurol. 2025 Oct 14;16:1568728. doi: 10.3389/fneur.2025.1568728. eCollection 2025.

  PMID: 41164394 DERIVED

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

Francesca Cecchi

CONTACT

+39 3388627184; fcecchi@dongnocchi.it

Stefano Doronzio

CONTACT

+39 3924685537; sdoronzio@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three phases: in the first, focus groups and living labs are conducted to co-create the solution with patients; in the second, as the first action of the cmRCT, an RCT is conducted to verify the effectiveness of the initial ROOMMATE system; in the third, a pilot is conducted to preliminarily test the advanced version of the ROOMMATE system.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 11, 2024
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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

Locations

IT (1)