Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270420
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-13
Brief Title:
Technological Devices and Home Automation System in Neurological Rehabilitation
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
Treatment Improvement With the Use of Innovative Technologies and Robotics in Rehabilitation Process Observational Longitudinal Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
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 ie 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 eg 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 1hday 5dayweek 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
The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room ie 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 eg 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 1hday 5dayweek 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 Parkinsons 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 patients 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 5timeweek for 3 weeks will consist of 1 hourday of motor training provided by technological devices ie 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 ie usability technology acceptability and user satisfaction
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 5timeweek for 3 weeks will consist of 1 hourday of motor training provided by technological devices ie 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 ie usability technology acceptability and user satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None