SocIal ROBOTics for Active and Healthy Ageing

Parkinson Disease Clinical Trial

— SI-ROBOTICS  

Official title:

SocIal ROBOTics for Active and Healthy Ageing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005208
• Other study ID #: INRCA_001_2021
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: March 29, 2024

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Roberta Bevilacqua
• Phone: 00390718004767
• Email: r.bevilacqua[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.h tml) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Parkinson Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona
Italy	IRCCS INRCA Hospital	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	Ministero dell'Università e della Ricerca, Italia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in acceptability of the SI-ROBOTICS system	Acceptability will be assessed using a 52-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance.; The questionnaire has 52 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions.; Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in walking speed	The walking speed will be evaluated by the Six-Minute Walking Test (6MWT).	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in balance	The change in balance will be evaluated by the Performance-Oriented Mobility Assessment (POMA) consists of two sub-scales: the balance evaluation scale ("balance scale" or POMA-B) and the gait evaluation scale ("gait scale" or POMA-G). The maximum score is 28 points: in detail, the maximum score of the POMA-B is 16, while for the POMA-G the maximum score is 12.	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in fear of falling	The change in fear of falling will be evaluated by the Short Falls Efficacy Scale - International (FES-I- Short). The cut offs are divided as follows: a score between 7-8 indicates a low concern, between 9-12 a moderate concern and between 14 and 28, high concern.	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in physical performance	Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in mobility	Change in mobility will be evaluated by Timed-Up-and-Go (TUG) Test. A score of ten seconds or less indicates normal mobility; times between 11 and 20 seconds are within normal limits for frail elderly and disabled patients; times over 20 seconds indicate that the person requires external assistance and the need for further examination and intervention. A score above 30 seconds suggests that the person may be prone to falls.	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in goal attainment scale	Change in goal attainment scale (GAS): definition of an individual goal at start, followed by a 6- point numeric scale indicating to what extent the goal is (score 0 till +2) or is not (-3 indicating detoriation till -1) reached.	change from baseline to 4 and 8 weeks after intervention commencement
Secondary	Change in quality of life	SF-12 Health Survey (SF-12) is composed of 12 items that produce two measurements related to two different aspects of health: physical health and mental health.	change from baseline to 4 and 8 weeks after intervention commencement