NCT06728020Not yet recruiting
AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care. (ROOMMATE)
ROOMMATE - AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care.
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- Apr 2025
- Primary completion date
- May 2026
- Lead sponsor
- Francesca Cecchi
- Diseases
- Stroke
- NCT number
- NCT06728020
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Apr 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi onlus Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.