Parkinson DiseaseSI-ROBOTICSNCT05005208
SocIal ROBOTics for Active and Healthy Ageing
A study testing rehabilitation program with the support of the technological platform SI-ROBOTICS in people with Parkinson Disease and Aging, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease, Aging
- What is being tested?
- rehabilitation program with the support of the technological platform SI-ROBOTICS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 19 May 2022to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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''.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS INRCA Hospital
Ancona, 60127
Anna Rita Bonfigli, MSc, 00390718003719, a.bonfigli@inrca.it
- Recruiting
IRCCS INRCA Hospital
Ancona
Elvira Maranesi, e.maranesi@inrca.it
Giovanni Riccardi
About this study
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.
Read the 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
- Being tested
- rehabilitation program with the support of the technological platform SI-ROBOTICS
- Keywords
- Parkinson disease, Older people, Robot, Technology-integrated intervention, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation program with the support of the technological platform SI-ROBOTICSOther
Also called SI-ROBOTICS a technological system facilitating a rehabilitation program
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Experimental | PD subjects will be going through a rehabilitation program based on an Irish dance with the support of the technological platform SI-ROBOTICS Receives: Other: rehabilitation program with the support of the technological platform SI-ROBOTICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
Secondary outcomes (7)
Change in walking speed
The walking speed will be evaluated by the Six-Minute Walking Test (6MWT).
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
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.
Measured: change from baseline to 4 and 8 weeks after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start19 May 2022
- Primary completion29 Mar 2024 (estimated)
- Study completion29 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero dell'Università e della Ricerca, Italia
- Responsible party
- Sponsor
- Investigators
- Giovanni Riccardi, MD, Principal investigator, IRCCS-INRCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005208
- Sponsor's protocol ID
- INRCA_001_2021
- Acronym
- SI-ROBOTICS
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available to other researchers following a documented request to the INRCA investigators.
Publications
Bevilacqua R, Maranesi E, Benadduci M, Cortellessa G, Umbrico A, Fracasso F, Melone G, Margaritini A, La Forgia A, Di Bitonto P, Potenza A, Fiorini L, La Viola C, Cavallo F, Leone A, Caroppo A, Rescio G, Marzorati M, Cesta A, Pelliccioni G, Riccardi GR, Rossi L. Exploring Dance as a Therapeutic Approach for Parkinson Disease Through the Social Robotics for Active and Healthy Ageing (SI-Robotics): Results From a Technical Feasibility Study. JMIR Aging. 2025 Jan 14;8:e62930. doi: 10.2196/62930.
PubMed 39810317Bevilacqua 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.
PubMed 34993171
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SocIal ROBOTics for Active and Healthy Ageing
- ClinicalTrials.gov ID
- NCT05005208
- Acronym / sponsor ID
- SI-ROBOTICS / INRCA_001_2021
- Conditions
- Parkinson Disease, Aging
- Keywords
- Parkinson disease, Older people, Robot, Technology-integrated intervention, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministero dell'Università e della Ricerca, Italia
- Study start
- 19 May 2022 (actual)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | Experimental | Other: rehabilitation program with the support of the technological platform SI-ROBOTICSPD subjects will be going through a rehabilitation program based on an Irish dance with the support of the technological platform SI-ROBOTICS |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitation program with the support of the technological platform SI-ROBOTICSAlso: SI-ROBOTICS a technological system facilitating a rehabilitation programA 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. | Other | Rehabilitation Group |
Primary outcome
Change in acceptability of the SI-ROBOTICS system
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
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.
7 secondary outcomes
Change in walking speed
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in balance
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in fear of falling
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in physical performance
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in mobility
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in goal attainment scale
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Change in quality of life
Time frame: change from baseline to 4 and 8 weeks after intervention commencement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39810317Bevilacqua R, Maranesi E, Benadduci M, Cortellessa G, Umbrico A, Fracasso F, Melone G, Margaritini A, La Forgia A, Di Bitonto P, Potenza A, Fiorini L, La Viola C, Cavallo F, Leone A, Caroppo A, Rescio G, Marzorati M, Cesta A, Pelliccioni G, Riccardi GR, Rossi L. Exploring Dance as a Therapeutic Approach for Parkinson Disease Through the Social Robotics for Active and Healthy Ageing (SI-Robotics): Results From a Technical Feasibility Study. JMIR Aging. 2025 Jan 14;8:e62930. doi: 10.2196/62930.
- Derived from this study: PubMed 34993171Bevilacqua 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.
- Individual participant dataSharing planned: No. Data will be available to other researchers following a documented request to the INRCA investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Riccardi, MD principal investigator
IRCCS-INRCA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation program with the support of the technological platform SI-ROBOTICS in people with Parkinson Disease and Aging, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Bevilacqua (00390718004767, r.bevilacqua@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acceptability of the SI-ROBOTICS system (time frame: change from baseline to 4 and 8 weeks after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.