NCT04087031 Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
| NCT ID | NCT04087031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2019-12-03 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.
Eligibility Criteria
Inclusion Criteria: * Hoen and Yahr scale: 1-3 stage * FAC ≤ 2 * Ranking scale score ≤ 3 * Stability of drug treatment for at least 1 month * Geriatric Depression Scale 5-items: negative Exclusion Criteria: * Concomitant participation in other studies * Lack of written informed consent * Clinical dementia rating (CDR) score ≥ 3 * 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 diseases * Severe systemic diseases with life expectancy \< 1 year * Patients unable to follow up.
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