SocIal ROBOTics for Active and Healthy Ageing

NCT ID: NCT05005208

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2024-03-29

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.

Conditions

Parkinson Disease; Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Rehabilitation Group

PD subjects will be going through a rehabilitation program based on an Irish dance with the support of the technological platform SI-ROBOTICS

Group Type: EXPERIMENTAL

rehabilitation program with the support of the technological platform SI-ROBOTICS

Intervention Type: OTHER

A 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.

Interventions

rehabilitation program with the support of the technological platform SI-ROBOTICS

A 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.

Intervention Type: OTHER

Other Intervention Names

SI-ROBOTICS a technological system facilitating a rehabilitation program

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministero dell'Università e della Ricerca, Italia

UNKNOWN

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Riccardi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS-INRCA

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: NOT_YET_RECRUITING

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Bevilacqua

Role: CONTACT

r.bevilacqua@inrca.it

00390718004767

Elvira Maranesi

Role: CONTACT

e.maranesi@inrca.it

00390718004767

Facility Contacts

Anna Rita Bonfigli, MSc

Role: primary

a.bonfigli@inrca.it

00390718003719

Elvira Maranesi

Role: primary

e.maranesi@inrca.it

References

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.

Reference Type: DERIVED

PMID: 34993171 (View on PubMed)

Other Identifiers

INRCA_001_2021

Identifier Type: -

Identifier Source: org_study_id