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SocIal ROBOTics for Active and Healthy Ageing (SI-ROBOTICS)

Primary Purpose

Parkinson Disease, Aging

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
rehabilitation program with the support of the technological platform SI-ROBOTICS
Sponsored by
Istituto Nazionale di Ricovero e Cura per Anziani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson disease, Older people, Robot, Technology-integrated intervention, Rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS INRCA Hospital
  • IRCCS INRCA HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rehabilitation Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in walking speed
The walking speed will be evaluated by the Six-Minute Walking Test (6MWT).
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 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 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 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 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 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.

Full Information

First Posted
August 5, 2021
Last Updated
October 20, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
Ministero dell'Università e della Ricerca, Italia
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1. Study Identification

Unique Protocol Identification Number
NCT05005208
Brief Title
SocIal ROBOTics for Active and Healthy Ageing
Acronym
SI-ROBOTICS
Official Title
SocIal ROBOTics for Active and Healthy Ageing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
Ministero dell'Università e della Ricerca, Italia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Aging
Keywords
Parkinson disease, Older people, Robot, Technology-integrated intervention, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation Group
Arm Type
Experimental
Arm Description
PD subjects will be going through a rehabilitation program based on an Irish dance with the support of the technological platform SI-ROBOTICS
Intervention Type
Other
Intervention Name(s)
rehabilitation program with the support of the technological platform SI-ROBOTICS
Other Intervention Name(s)
SI-ROBOTICS a technological system facilitating a rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in acceptability of the SI-ROBOTICS system
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Secondary Outcome Measure Information:
Title
Change in walking speed
Description
The walking speed will be evaluated by the Six-Minute Walking Test (6MWT).
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in balance
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in fear of falling
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in physical performance
Description
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
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in mobility
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in goal attainment scale
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement
Title
Change in quality of life
Description
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.
Time Frame
change from baseline to 4 and 8 weeks after intervention commencement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Bevilacqua
Phone
00390718004767
Email
r.bevilacqua@inrca.it
First Name & Middle Initial & Last Name or Official Title & Degree
Elvira Maranesi
Phone
00390718004767
Email
e.maranesi@inrca.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Riccardi, MD
Organizational Affiliation
IRCCS-INRCA
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS INRCA Hospital
City
Ancona
ZIP/Postal Code
60127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Rita Bonfigli, MSc
Phone
00390718003719
Email
a.bonfigli@inrca.it
Facility Name
IRCCS INRCA Hospital
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvira Maranesi
Email
e.maranesi@inrca.it
First Name & Middle Initial & Last Name & Degree
Giovanni Riccardi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available to other researchers following a documented request to the INRCA investigators.
Citations:
PubMed Identifier
34993171
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.
Results Reference
derived

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SocIal ROBOTics for Active and Healthy Ageing

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