Clinical Trials Directory

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UnknownNCT05005208

SocIal ROBOTics for Active and Healthy Ageing

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERrehabilitation program with the support of the technological platform SI-ROBOTICSA 16-treatment session will be conducted, divided into 2 training sessions per week, for 8 weeks. The therapy sessions last 60 minutes; each session will involve 2 patients at time. Cardiac and respiratory activity monitoring is planned during robotic treatments in order to detect the heart rate during physical activity. Individual participants must complete at least 80% of the sessions. Recovery of 2 sessions will be possible. Each session involves the following activities: * Breathing, relaxation and postural harmonization exercises; * Active mobility and stretching exercises; * Irish dance with the SI-ROBOTICS system; * Relaxation exercises.

Timeline

Start date
2022-05-19
Primary completion
2024-03-29
Completion
2024-03-29
First posted
2021-08-13
Last updated
2023-10-23

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT05005208. Inclusion in this directory is not an endorsement.