Motor Disorders, Neurological Disease
Conditions
Keywords
Home Automation, Sensorized environment, Organizational model, Neurological rehabilitation, Technological Innovation, Motor Recovery
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).
Interventions
DEVICETechnological Motor Rehabilitation
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.
Sponsors
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Longitudinal Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Key performance indicator (KPI) of the room - Number of treatments | 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 | 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 | 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 | 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 | Every month up to 1 year | Number of adverse events detected in the HoSmartAI room. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Ambulation Categories (FAC) | Change from Baseline FAC at 3 weeks | 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). |
| Trunk Control Test (TCT) | Change from Baseline TCT at 3 weeks | 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 |
| EuroQol questionnaire (EQ-5D) | Change from Baseline EQ-5D at 3 weeks | 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. |
| Box and Blocks Test | Change from Baseline Box and Blocks Test at 3 weeks | 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. |
| Short Form Patient Satisfaction Questionnaire (PSQ-18) | Change from Baseline PSQ-18 at 3 weeks | 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 |
| User Experience Questionnaire (UEQ) | Change from Baseline UEQ at 3 weeks | 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). |
| Number of falls | Require multiple time points before the training to obtain the value (i.e.,12 months, 3 weeks) | The patients has to count the number of falls in the last year (i.e., 12 months) and in the last 3 weeks. |
| System Usability Scale (SUS) | Change from Baseline SUS at 3 weeks | 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). |
| Reaching Performance Scale | Change from Baseline Reaching Performance Scale at 3 weeks | 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. |
| Nine Hole Pegboard Test | Change from Baseline Nine Hole Pegboard Test at 3 weeks | 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. |
| Berg balance scale (BBS) | Change from Baseline BBS at 3 weeks | 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). |
| 10 Meter Walk Test (10MWT) | Change from Baseline 10MWT at 3 weeks | 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. |
Countries
Italy
Contacts
Primary ContactGiorgia Pregnolato
Backup ContactValeria Campanini
Outcome results
None listed