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| Name | Class |
|---|---|
| Ministero dell'Università e della Ricerca, Italia | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Bevilacqua | Contact | 00390718004767 | r.bevilacqua@inrca.it | |
| Elvira Maranesi | Contact | 00390718004767 | e.maranesi@inrca.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Riccardi, MD | IRCCS-INRCA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS INRCA Hospital | Not yet recruiting | Ancona | 60127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34993171 | Derived | 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. |
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Data will be available to other researchers following a documented request to the INRCA investigators.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| 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. | 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 | 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. | 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. | 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. | change from baseline to 4 and 8 weeks after intervention commencement |
| IRCCS INRCA Hospital | Recruiting | Ancona | Italy |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |