SocIal ROBOTics for Active and Healthy Ageing

NCT05005208 | Unknown

• 1 other identifier: INRCA_001_2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Aging

Keywords

Parkinson disease; Older people; Robot; Technology-integrated intervention; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in walking speed

  change from baseline to 4 and 8 weeks after intervention commencement

• Change in balance

  change from baseline to 4 and 8 weeks after intervention commencement

• Change in fear of falling

  change from baseline to 4 and 8 weeks after intervention commencement

• Change in physical performance

  change from baseline to 4 and 8 weeks after intervention commencement

• Change in mobility

  change from baseline to 4 and 8 weeks after intervention commencement

Study Arms (1)

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

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

Interventions

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

Also known as: SI-ROBOTICS a technological system facilitating a rehabilitation program

Rehabilitation Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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''.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Ministero dell'Università e della Ricerca, Italia: collaborator

Study Sites (2)

IRCCS INRCA Hospital

Ancona, 60127, Italy

NOT YET RECRUITING

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 34993171 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Giovanni Riccardi, MD

  IRCCS-INRCA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Bevilacqua

CONTACT

00390718004767; r.bevilacqua@inrca.it

Elvira Maranesi

CONTACT

00390718004767; e.maranesi@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: May 19, 2022
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)