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Clinical Trials in Italy / NCT06728020
Starting soon Not applicable

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

NCT06728020 · tracked via the Priya Life Science Italy tracker
Sponsor
Francesca Cecchi
Phase
Not applicable
Started
2025-04
Last updated
2025-03-21

Condition(s) studied

Subacute StrokeStroke; Subacute

Investigational drug(s) / intervention(s)

Active Comparator: Conventional rehabilitation (Group A)ROOMMATE 1stROOMMATE 2nd

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.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • modified Barthel index (mBI) — baseline, 3 week
    Assessment of disability in ADLs, scoring 0-100

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione Don Carlo Gnocchi Onlus Florence Florence
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728020 on ClinicalTrials.gov ↗ ← All trials in Italy