Hand Rehab Using AMADEO in PD Patients (NCT04045080) | Clinical Trial Compass
UnknownNot Applicable
Hand Rehab Using AMADEO in PD Patients
Italy40 participantsStarted 2019-09-01
Plain-language 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 enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.