ROOMMATE - AggRegated System of SensOrs and Multimedia Monitors: Technology for InnovAtion and PersonalizaTion of REhabilitation Care.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- modified Barthel index (mBI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
modified Barthel index (mBI)
时间窗: baseline, 3 week
Assessment of disability in ADLs, scoring 0-100
次要结局
- 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)
- Short Form 12 item(baseline, 3 week)
- Training-Evaluation-Inventory (TEI)(3 week)
- Short Version of the User Experience Questionnaire (UEQ-S)(3 week)
- Final Measurement Scales for Perceived Usefulness and Perceived Ease of Use(3 week)
- HUBBI - eHealth UsaBility Benchmarking Instrument(3 week)
- Motricity Index(baseline, 3 week)
- we wearability test(3 week)
研究者
Francesca Cecchi
Associate Professor
Fondazione Don Carlo Gnocchi Onlus