Clinical trial NCT05005208: SocIal ROBOTics for Active and Healthy Ageing
Official title: SocIal ROBOTics for Active and Healthy Ageing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Aging
Keywords: Parkinson disease
Older people
Robot
Technology-integrated intervention
Rehabilitation
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministero dell'Università e della Ricerca, Italia
First posted: 2021-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study was designed to test the acceptability of the Si-Robotics system in a group of 20 subjects with Parkinson's Disease at an early stage, during a rehabilitation treatment based on Irish dancing. Assessments will be performed at the baseline and at the end of the treatment.

Detailed description: The study was designed to test the acceptability of the SI-ROBOTICS system in a group of 20 subjects with Parkinson's Disease at an early stage during a rehabilitation treatment.

The SI-ROBOTICS system is composed of multiple technological components with the aim of facilitating a rehabilitation program based on Irish dance and encouraging the execution of dance steps. The SI-ROBOTICS system consists of:

* ROBOTIC PLATFORM: a social robot that allows the monitoring of patients during sessions, moving around patients safely and, if necessary, intervening in their support.
* LET'S DANCE GAME: a component that allows users to enjoy the game sessions (setting up of therapy sessions by the therapist, presentation of tasks to the player and execution by the latter, display of feedback on the sessions).
* ENVIRONMENTAL AND WEARABLE SENSORS: this allows data to be collected on the patient's main clinical parameters (e.g. heart rate, respiratory rate, etc.). These data allow the therapist to know the patient's state during the execution of tasks and the AI reasoner component to have an additional level of information with which to adapt the planning of steps.
* AI REASONERS: this is the back-end of the Si-Robotics system, i.e. the "intelligent" component that allows the adaptation of the game sessions, based on the users' game performance and the data collected through the sensors. In this way it will be possible to dynamically customize the session according to the user's needs and abilities.
* ARTIFICIAL VISION SETTING: a commercial camera called Inter Real Sense (https://www.intel.it/content/www/it/it/architecture-and-technology/realsense-overview.html) will be installed in the experimental setting for the extraction of kinematic parameters, saved anonymously and locally on this computer. Also the robotic platform will be equipped with a RealSense camera and will be able to acquire kinematic parameters. To extract features of interest from the signals, proprietary skeleton tracking software of the Real Sense camera will be used, together with specially developed algorithms for feature extraction.

In addition, kinematic and performance parameters will be collected, which will be used by the physiotherapist to evaluate and plan subsequent sessions, and by the system to delineate the levels of difficulty of the exercise.

Eligibility criteria: Inclusion Criteria:

* Capacity to consent;
* Hoen and Yahr scale: 1-2 stage;
* Functional Ambulation Category (FAC) ≥ 2;
* Ranking scale score ≤ 3;
* Stability of drug treatment for at least 1 month;
* Geriatric Depression Scale 4-items ≤ 1;
* Mini Mental State Examination ≥ 24;
* Maintaining an upright posture ≥ 30''.

Exclusion Criteria:

* History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically;
* Serious dysfunction of the autonomic system;
* Severe behavioral syndromes not compensated by drugs;
* Concurrent neurological and/or cardiac diseases;
* Recent femur fracture
* Chronic medium to severe pain affecting standing or walking.

Primary outcomes:
measure: Change in acceptability of the SI-ROBOTICS system
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
Secondary outcomes:
measure: Change in walking speed
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in balance
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in fear of falling
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in physical performance
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in mobility
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in goal attainment scale
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
measure: Change in quality of life
timeFrame: change from baseline to 4 and 8 weeks after intervention commencement
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS-INRCA
name: Giovanni Riccardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bevilacqua R, Benadduci M, Bonfigli AR, Riccardi GR, Melone G, La Forgia A, Macchiarulo N, Rossetti L, Marzorati M, Rizzo G, Di Bitonto P, Potenza A, Fiorini L, Cortellessa Loizzo FG, La Viola C, Cavallo F, Leone A, Rescio G, Caroppo A, Manni A, Cesta A, Cortellessa G, Fracasso F, Orlandini A, Umbrico A, Rossi L, Maranesi E. Dancing With Parkinson's Disease: The SI-ROBOTICS Study Protocol. Front Public Health. 2021 Dec 21;9:780098. doi: 10.3389/fpubh.2021.780098. eCollection 2021.