Clinical trial NCT06270420: Technological Devices and Home Automation System in Neurological Rehabilitation
Official title: Treatment Improvement With the Use of Innovative Technologies and Robotics in Rehabilitation Process: Observational Longitudinal Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurological Disease
Motor Disorders
Keywords: Home Automation
Sensorized environment
Organizational model
Neurological rehabilitation
Technological Innovation
Motor Recovery
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal Pilot study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.

The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room.

Detailed description: The recovery of motor function is a primary goal for individuals diagnosed with neurological disease, such as Stroke, Parkinson's Disease, Multiple Sclerosis. Various rehabilitation methods have been using in neurorehabilitation hospital, including conventional training and those involving technological devices. Nowadays, the integration of technology into rehabilitation room has been expanding within the National Health System, and their effectiveness in enhancing functionality and quality of life remains a subject of ongoing research in rehabilitation. In addition to rehabilitation devices, such as robotic and virtual reality systems, home automation system may play a crucial role in monitoring and recording patient movements. These sensors can also be employed for home automation in environments such as hospital rehabilitation settings, helping to reduce paid carer hours, quantify the impact of automated data acquisition on the functionality and offer many benefits to people with a disability. Indeed, potentially, the application of home automation system in technological rehabilitation rooms, may allow for the synchronization of environmental data with the patient's clinical history, facilitating the study of functional recovery.

This study is a part of the HosmartAI project (EU Horizon 2020 research and innovation program - grant agreement No 101016834 Pilot #3). The main aim of HoSmartAI project is to develop hospitals based on artificial intelligence (AI) technologies. In Pilot #3, the investigators will integrate data collected by technological devices for motor rehabilitation and home automation sensors installed in room (HosmartAI room) at the Neuromotor Rehabilitation Service of the San Camillo IRCCS Hospital (Venice, Italy). These sensors are able to detect the effective numbers of minutes of therapy, the number of sessions delivered in the room, and detect the presence and falls of the patients. Moreover, all these sensors are managed directly by physiotherapists through an App for smartphone. All data collected will be integrated in a cloud infrastructure, where physiotherapist will check the patients' profile and data collected from clinical assessment and home automation sensors.

In the study, the investigators will enroll patients with neurological disease and motor impairment who are hospitalized in Camillo IRCCS Hospital (Venice, Italy). The treatment (5time/week, for 3 weeks) will consist of 1 hour/day of motor training provided by technological devices (i.e., OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room, in addition to daily 1 hour of conventional motor training. Firstly, the patients will be assessed to define their motor function and personalize the treatment based on their needs, to improve balance, manual dexterity, or upper and lower limb motor recovery. Then, at the end of the treatment, the patients will be assessed using validated clinical scales and questionnaire to determine the clinical effect and patient-reported outcome measurements (i.e., usability, technology acceptability, and user satisfaction).

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 yy)
* Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)

Exclusion Criteria:

* Fractures
* Major depressive disorder
* Severe visual and/or hearing impairments
* Dementia
* Non-pharmacologically controlled epilepsy
* Severe neglect
* Severe comprehension deficit

Primary outcomes:
measure: Key performance indicator (KPI) of the room - Number of treatments
timeFrame: Every month up to 1 year
measure: Key performance indicator (KPI) ot the room - Number of sessions
timeFrame: Every month up to 1 year
measure: Room Key performance indicator (KPI) of the room - Number of minutes of therapy
timeFrame: Every month up to 1 year
measure: Key performance indicator (KPI) of the room - Number of physiotherapists involved
timeFrame: Every month up to 1 year
measure: Key performance indicator (KPI) of the room - Number of adverse events
timeFrame: Every month up to 1 year
Secondary outcomes:
measure: Box and Blocks Test
timeFrame: Change from Baseline Box and Blocks Test at 3 weeks
measure: Reaching Performance Scale
timeFrame: Change from Baseline Reaching Performance Scale at 3 weeks
measure: Nine Hole Pegboard Test
timeFrame: Change from Baseline Nine Hole Pegboard Test at 3 weeks
measure: Berg balance scale (BBS)
timeFrame: Change from Baseline BBS at 3 weeks
measure: 10 Meter Walk Test (10MWT)
timeFrame: Change from Baseline 10MWT at 3 weeks
measure: Functional Ambulation Categories (FAC)
timeFrame: Change from Baseline FAC at 3 weeks
measure: Trunk Control Test (TCT)
timeFrame: Change from Baseline TCT at 3 weeks
measure: EuroQol questionnaire (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 3 weeks
measure: System Usability Scale (SUS)
timeFrame: Change from Baseline SUS at 3 weeks
measure: Short Form Patient Satisfaction Questionnaire (PSQ-18)
timeFrame: Change from Baseline PSQ-18 at 3 weeks
measure: User Experience Questionnaire (UEQ)
timeFrame: Change from Baseline UEQ at 3 weeks
measure: Number of falls
timeFrame: Require multiple time points before the training to obtain the value (i.e.,12 months, 3 weeks)
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: IRCCS San Camillo Hospital
state: Venice
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Giorgia Pregnolato
role: STUDY_CHAIR
References:
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