Status:
RECRUITING
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Lead Sponsor:
Istituto Nazionale di Ricovero e Cura per Anziani
Conditions:
Parkinson Disease
Frail Elderly
Eligibility:
All Genders
65+ years
Phase:
NA
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 tr...
Detailed Description
Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04087031
Start Date
December 3 2019
End Date
December 31 2026
Last Update
October 23 2023
Active Locations (2)
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1
IRCCS INRCA Hospital
Ancona, Italy, 60131
2
IRCCS INRCA Hospital
Fermo, Italy