Hand rehabilitation for patients with Parkinson's Disease using AMADEO
The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease
NA · IRCCS Centro Neurolesi Bonino Pulejo · NCT04045080
This study is testing if the AMADEO® system can help people with Parkinson's Disease improve their hand and finger movements through different types of training.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo (other) |
| Locations | 1 site (Messina) |
| Trial ID | NCT04045080 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the AMADEO® end-effector system in improving hand and finger movements in patients with Parkinson's Disease. The AMADEO® system allows for intensive training through various modes, including passive, assistive, and active, focusing on finger strength and movement control. Participants will undergo training to assess improvements in finger tapping, agility, and overall hand movement functionality, measured through established clinical scales and electromyographic parameters.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with idiopathic Parkinson's Disease, in Hoehn-Yahr stages 1 to 3, who are currently in the 'On' state and have a Mini-Mental State Examination score of 24 or higher.
Not a fit: Patients with atypical Parkinsonisms, severe dyskinesia, or those who have undergone specific surgical interventions for Parkinson's may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance hand function and daily living activities for patients with Parkinson's Disease.
How similar studies have performed: While the use of robotic rehabilitation systems in Parkinson's Disease is gaining traction, the specific application of the AMADEO® system in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Messina
- IRCCS Centro Neurolesi "Bonino-Pulejo" — Messina, Italy (RECRUITING)
Study contacts
- Study coordinator: Rocco S Calabrò
- Email: salbro77@tiscali.it
- Phone: +3909060128166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease