Status:
RECRUITING
Hand Rehab Using AMADEO in PD Patients
Lead Sponsor:
IRCCS Centro Neurolesi Bonino Pulejo
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system e...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Idiopathic PD diagnosed according to the Gelb's criteria;
- Hoehn-Yahr stage 1- 3
- "On" state
- MMSE score ≥ 24
- Willing and able to give written informed consent;
- Willing and able to comply with the study procedures.
- Exclusion Criteria
- A specific kind of fluctuation: Sudden on-off fluctuations
- History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
- History of stereotaxic brain surgery for PD;
- Mini-mental examination (MMSE) score less than 24 at screening;
- Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
- Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
- Presence of severe dyskinesia prior to baseline;
- Any other medical or psychiatric condition that may compromise the patient's participation in this study;
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04045080
Start Date
September 1 2019
End Date
June 1 2024
Last Update
March 19 2024
Active Locations (1)
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1
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy, 98124