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Clinical Trial NCT06728020 (ROOMMATE) for Subacute Stroke, Stroke; Subacute is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care. (ROOMMATE) 200 Randomized Virtual
Clinical Trial NCT06728020 (ROOMMATE) is an interventional study for Subacute Stroke, Stroke; Subacute and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2025 and continue until the study accrues 200 participants. Led by Francesca Cecchi, this study is expected to complete by 1 May 2026. The latest data from ClinicalTrials.gov was last updated on 21 March 2025.
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:
-T...
Show MoreDetailed 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 ...
Show MoreOfficial Title
ROOMMATE - AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care.
Conditions
Subacute StrokeStroke; SubacutePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- ROOMMATE
- cmRCT ROOMMATE
- Grant Agreement Nº: 101095654. (Other Grant/Funding Number) (Tranforming Health and Care Systems partnership)
NCT ID Number
Start Date (Actual)
2025-04
Last Update Posted
2025-03-21
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
subacute stroke
Neurorehabilitation
Assistive/rehabilitation robotics
Digital health
Continuum of care
People-centered care
Accessible care
Innovation adoption
cmRCT
Enriched environment
Neurorehabilitation
Assistive/rehabilitation robotics
Digital health
Continuum of care
People-centered care
Accessible care
Innovation adoption
cmRCT
Enriched environment
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorConventional 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. | 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. |
ExperimentalROOMMATE 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. | 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. |
ExperimentalROOMMATE 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
modified Barthel index (mBI) | Assessment of disability in ADLs, scoring 0-100 | baseline, 3 week |
| 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 |
Hearts Test | 3-minute visual attention barrage test, scores 0-50 | 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 |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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;
- presence of signs of clinical instability, defined by a score greater than zero on the Clinical Instability Scale (SIC).
Francesca Cecchi- 🏛️MEDEA, Italy
Study Responsible Party
Francesca Cecchi, Sponsor-Investigator, Associate Professor, Fondazione Don Carlo Gnocchi Onlus
Study Central Contact
Contact: Francesca Cecchi, +39 3388627184, [email protected]
Contact: Stefano Doronzio, +39 3924685537, [email protected]
1 Study Locations in 1 Countries
Florence
IRCCS Fondazione Don Carlo Gnocchi Onlus, Florence, Florence, Italy
Francesca Cecchi, Associate Professor, Contact, +39 3388627184, [email protected]
Stefano Doronzio, PT, Phds, Contact, +39 3924685537, [email protected]
Francesca Cecchi, Associate Professor, Principal Investigator
Stefano Doronzio, PT, Phds, Sub-Investigator