Neurological DiseaseSMARTNCT06270420
Technological Devices and Home Automation System in Neurological Rehabilitation
A study testing Technological Motor Rehabilitation in people with Neurological Disease and Motor Disorders, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurological Disease, Motor Disorders
- What is being tested?
- Technological Motor Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (> 18 yy)
- Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)
Who cannot join
- Fractures
- Major depressive disorder
- Severe visual and/or hearing impairments
- Dementia
- Non-pharmacologically controlled epilepsy
- Severe neglect
- Severe comprehension deficit
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo Hospital
Venice-Lido, Venice, 30126
Giorgia Pregnolato, +0412207 ext. 214, giorgia.pregnolato@hsancamillo.it
About this study
Official title: Treatment Improvement With the Use of Innovative Technologies and Robotics in Rehabilitation Process: Observational Longitudinal Pilot Study
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.
Read the 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).
- Conditions
- Neurological Disease, Motor Disorders
- Being tested
- Technological Motor Rehabilitation
- Keywords
- Home Automation, Sensorized environment, Organizational model, Neurological rehabilitation, Technological Innovation, Motor Recovery
- Medical subject headings
- Nervous System Diseases, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological Motor RehabilitationDevice
Patients will undergo to motor treatment in the HoSmartAI room using one of the technological devices (i.e. OAK, VRRS Evo by Khymeia Group, Padova, Italy; AMADEO, PABLO by Tyromotion GmbH, Gratz, Austria), for the upper limb and lower limb motor recovery, balance and manual dexterity recovery. The duration of the treatment will be 15 sessions, 1 hour each, with daily frequency, 5 days a week, for a total of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HosmartAI training | Experimental | HosmartAI training will consist of motor training provided by technological devices (i.e. OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room. Receives: Device: Technological Motor Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key performance indicator (KPI) of the room - Number of treatments
Number of treatments that are provided inside the HoSmartAI room.
Measured: Every month up to 1 year
Key performance indicator (KPI) ot the room - Number of sessions
Number of sessions that are provided inside the HoSmartAI room.
Measured: Every month up to 1 year
Room Key performance indicator (KPI) of the room - Number of minutes of therapy
Number of minutes of therapy that are provided inside the HoSmartAI room.
Measured: Every month up to 1 year
Key performance indicator (KPI) of the room - Number of physiotherapists involved
Number of physiotherapists involved inside the HoSmartAI room.
Measured: Every month up to 1 year
Key performance indicator (KPI) of the room - Number of adverse events
Number of adverse events detected in the HoSmartAI room.
Measured: Every month up to 1 year
Secondary outcomes (12)
Box and Blocks Test
The patient has to carry as much cubes as possible, one by one, from a box to another one in one minute. The test is performed with both hands.
Measured: Change from Baseline Box and Blocks Test at 3 weeks
Reaching Performance Scale
Reaching Performance Scale assesses the ability of subjects to reach an object (acone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The assessor valuates the quality of reaching instead of the grip strength. The minimum value is0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability to reach an object.
Measured: Change from Baseline Reaching Performance Scale at 3 weeks
Nine Hole Pegboard Test
Nine Hole Pegboard Test measures the dexterity of the hand. Patient should insert 9 pins in the board. The number of pins inserted in 50 sec are registered or if the patient inserted 9 pins, then the time is registered.
Measured: Change from Baseline Nine Hole Pegboard Test at 3 weeks
Berg balance scale (BBS)
BBS is a 14-item objective measure that assesses static balance and fall risk in adults. The minimum value is 0 (i.e., no stability and high fall risk) and the maximum value is 56 (i.e., no balance disorder and no fall risk).
Measured: Change from Baseline BBS at 3 weeks
10 Meter Walk Test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration.The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.Assistive devices may be used but must be documented from test to test.If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided. The level of assistance documented, however, should reflect the greatest amount of assistance provided during the test.
Measured: Change from Baseline 10MWT at 3 weeks
Functional Ambulation Categories (FAC)
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The minimum value is 0 (i.e., patient cannot walk) and the maximum value is 6 (i.e., patient can walk independently anywhere).
Measured: Change from Baseline FAC at 3 weeks
Trunk Control Test (TCT)
The TCT measures four simple aspects of trunk movement :rolling to weak side,rolling to strong side
- balance in sitting position
- sit up from lying down
Measured: Change from Baseline TCT at 3 weeks
EuroQol questionnaire (EQ-5D)
EQ-5D is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Measured: Change from Baseline EQ-5D at 3 weeks
System Usability Scale (SUS)
SUS is a widely used questionnaire for assessing the perceived usability of a system or product.The SUS consists of a 10-item questionnaire where users rate their agreement or disagreement with a series of statements regarding the usability of a system. The minimum value is 0 (i.e., the system is not usable) and the maximum value is 100 (i.e., the system is absolutely usable).
Measured: Change from Baseline SUS at 3 weeks
Short Form Patient Satisfaction Questionnaire (PSQ-18)
he Patient Satisfaction Questionnaire Short Form (PSQ-18) is a validated tool used to measure patient satisfaction with medical care. It is a shorter version of the 50-item Patient Satisfaction Questionnaire III (PSQ-III) 1. The PSQ-18 contains 18 items that measure seven dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience
Measured: Change from Baseline PSQ-18 at 3 weeks
User Experience Questionnaire (UEQ)
UEQ is a widely used questionnaire to measure the subjective impression of users towards the user experience of products. The UEQ is a semantic differential with 26 items that are grouped into six scales (Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, and Novelty). Each scale represents a distinct UX quality aspect. The minimum value is 0 (i.e., the worst user experience) and the maximum value is 100 (i.e., the best user experience).
Measured: Change from Baseline UEQ at 3 weeks
Number of falls
The patients has to count the number of falls in the last year (i.e., 12 months) and in the last 3 weeks.
Measured: Require multiple time points before the training to obtain the value (i.e.,12 months, 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start5 Feb 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neurological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal Pilot study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Pregnolato, Study chair, IRCCS San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270420
- Sponsor's protocol ID
- 2022.04
- Acronym
- SMART
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.
PubMed 30269804Orihuela-Espina F, Roldan GF, Sanchez-Villavicencio I, Palafox L, Leder R, Sucar LE, Hernandez-Franco J. Robot training for hand motor recovery in subacute stroke patients: A randomized controlled trial. J Hand Ther. 2016 Jan-Mar;29(1):51-7; quiz 57. doi: 10.1016/j.jht.2015.11.006. Epub 2015 Nov 26.
PubMed 26847320Latella D, Maggio MG, Maresca G, Andaloro A, Anchesi S, Pajno V, De Luca R, Di Lorenzo G, Manuli A, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with Parkinson's disease: A pilot study. Assist Technol. 2022 Jul 4;34(4):423-428. doi: 10.1080/10400435.2020.1846095. Epub 2021 Apr 6.
PubMed 33337294Maggio MG, Maresca G, Russo M, Stagnitti MC, Anchesi S, Casella C, Zichitella C, Manuli A, De Cola MC, De Luca R, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with chronic stroke: A pilot study. Disabil Health J. 2020 Jan;13(1):100838. doi: 10.1016/j.dhjo.2019.100838. Epub 2019 Sep 4.
PubMed 31501039Wolbring G, Lashewicz B. Home care technology through an ability expectation lens. J Med Internet Res. 2014 Jun 20;16(6):e155. doi: 10.2196/jmir.3135.
PubMed 24956581Cleland J, Hutchinson C, Williams PAH, Manuel K, Laver K. A scoping review to explore the health, social and economic outcomes of home automation for people with disability. Disabil Rehabil Assist Technol. 2024 May;19(4):1446-1453. doi: 10.1080/17483107.2023.2196308. Epub 2023 Apr 3.
PubMed 37012673
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Improvement With the Use of Innovative Technologies and Robotics in Rehabilitation Process: Observational Longitudinal Pilot Study
- ClinicalTrials.gov ID
- NCT06270420
- Acronym / sponsor ID
- SMART / 2022.04
- Conditions
- Neurological Disease, Motor Disorders
- Keywords
- Home Automation, Sensorized environment, Organizational model, Neurological rehabilitation, Technological Innovation, Motor Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal Pilot study
| Arm | Type | Receives |
|---|---|---|
| HosmartAI training | Experimental | Device: Technological Motor RehabilitationHosmartAI training will consist of motor training provided by technological devices (i.e. OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (> 18 yy)
- Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)
Key exclusion criteria (7 listed)
- Fractures
- Major depressive disorder
- Severe visual and/or hearing impairments
- Dementia
- Non-pharmacologically controlled epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technological Motor RehabilitationPatients will undergo to motor treatment in the HoSmartAI room using one of the technological devices (i.e. OAK, VRRS Evo by Khymeia Group, Padova, Italy; AMADEO, PABLO by Tyromotion GmbH, Gratz, Austria), for the upper limb and lower limb motor recovery, balance and manual dexterity recovery. The duration of the treatment will be 15 sessions, 1 hour each, with daily frequency, 5 days a week, for a total of 3 weeks. | Device | HosmartAI training |
Primary outcome
Key performance indicator (KPI) of the room - Number of treatments
Time frame: Every month up to 1 year
Number of treatments that are provided inside the HoSmartAI room.
Key performance indicator (KPI) ot the room - Number of sessions
Time frame: Every month up to 1 year
Number of sessions that are provided inside the HoSmartAI room.
Room Key performance indicator (KPI) of the room - Number of minutes of therapy
Time frame: Every month up to 1 year
Number of minutes of therapy that are provided inside the HoSmartAI room.
Key performance indicator (KPI) of the room - Number of physiotherapists involved
Time frame: Every month up to 1 year
Number of physiotherapists involved inside the HoSmartAI room.
Key performance indicator (KPI) of the room - Number of adverse events
Time frame: Every month up to 1 year
Number of adverse events detected in the HoSmartAI room.
12 secondary outcomes
Box and Blocks Test
Time frame: Change from Baseline Box and Blocks Test at 3 weeks
Reaching Performance Scale
Time frame: Change from Baseline Reaching Performance Scale at 3 weeks
Nine Hole Pegboard Test
Time frame: Change from Baseline Nine Hole Pegboard Test at 3 weeks
Berg balance scale (BBS)
Time frame: Change from Baseline BBS at 3 weeks
10 Meter Walk Test (10MWT)
Time frame: Change from Baseline 10MWT at 3 weeks
Functional Ambulation Categories (FAC)
Time frame: Change from Baseline FAC at 3 weeks
Trunk Control Test (TCT)
Time frame: Change from Baseline TCT at 3 weeks
EuroQol questionnaire (EQ-5D)
Time frame: Change from Baseline EQ-5D at 3 weeks
System Usability Scale (SUS)
Time frame: Change from Baseline SUS at 3 weeks
Short Form Patient Satisfaction Questionnaire (PSQ-18)
Time frame: Change from Baseline PSQ-18 at 3 weeks
User Experience Questionnaire (UEQ)
Time frame: Change from Baseline UEQ at 3 weeks
Number of falls
Time frame: Require multiple time points before the training to obtain the value (i.e.,12 months, 3 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 30269804Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.
- Background: PubMed 26847320Orihuela-Espina F, Roldan GF, Sanchez-Villavicencio I, Palafox L, Leder R, Sucar LE, Hernandez-Franco J. Robot training for hand motor recovery in subacute stroke patients: A randomized controlled trial. J Hand Ther. 2016 Jan-Mar;29(1):51-7; quiz 57. doi: 10.1016/j.jht.2015.11.006. Epub 2015 Nov 26.
- Background: PubMed 33337294Latella D, Maggio MG, Maresca G, Andaloro A, Anchesi S, Pajno V, De Luca R, Di Lorenzo G, Manuli A, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with Parkinson's disease: A pilot study. Assist Technol. 2022 Jul 4;34(4):423-428. doi: 10.1080/10400435.2020.1846095. Epub 2021 Apr 6.
- Background: PubMed 31501039Maggio MG, Maresca G, Russo M, Stagnitti MC, Anchesi S, Casella C, Zichitella C, Manuli A, De Cola MC, De Luca R, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with chronic stroke: A pilot study. Disabil Health J. 2020 Jan;13(1):100838. doi: 10.1016/j.dhjo.2019.100838. Epub 2019 Sep 4.
- Background: PubMed 24956581Wolbring G, Lashewicz B. Home care technology through an ability expectation lens. J Med Internet Res. 2014 Jun 20;16(6):e155. doi: 10.2196/jmir.3135.
- Background: PubMed 37012673Cleland J, Hutchinson C, Williams PAH, Manuel K, Laver K. A scoping review to explore the health, social and economic outcomes of home automation for people with disability. Disabil Rehabil Assist Technol. 2024 May;19(4):1446-1453. doi: 10.1080/17483107.2023.2196308. Epub 2023 Apr 3.
- The link of the Pilot #3 refers to the HoSmartAI projectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgia Pregnolato study chair
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological Motor Rehabilitation in people with Neurological Disease and Motor Disorders, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgia Pregnolato (+39 0412207 ext. 214, giorgia.pregnolato@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key performance indicator (KPI) of the room - Number of treatments (time frame: Every month up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270420, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.