Upper limb rehabilitation for people with Parkinson's disease
Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study
This study is testing if a robotic device can help people with mild to moderate Parkinson's disease improve their arm movements and strength better than regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 2 sites (Cassino, FR and 1 other locations) |
| Trial ID | NCT06906679 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of upper limb rehabilitation using a robotic device designed to improve movements, strength, and coordination in patients with Parkinson's disease who have mild to moderate disability. Participants will be randomly assigned to either an experimental group receiving robotic treatment or a control group receiving conventional rehabilitation. The study aims to assess improvements in upper limb coordination and functionality through specific tests. Additionally, it seeks to identify which subgroups of participants may benefit most from the robotic therapy based on their disease stage.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 80 with a diagnosis of Parkinson's disease and mild to moderate disability.
Not a fit: Patients with severe Parkinson's disease or those with overlapping neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with Parkinson's disease by improving their upper limb functionality.
How similar studies have performed: Other studies have shown promise with robotic-assisted therapies in rehabilitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 30 and 80 years; * Diagnosis of Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria; * Hoehn \& Yahr scale score between 2 and 3 in the "ON" phase; * Montreal Cognitive Assessment (MoCA) screening test with a score ≥ 17.54; * Stable pharmacological therapy for at least 4 weeks and throughout the treatment; * Ability to understand and sign the informed consent for the study; * Signed informed consent for the study; * Ability to comply with the study procedures. Exclusion Criteria: * Unable to adhere to the exercise program due to poor compliance; * Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders; * Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility; * Participants who have not signed the informed consent for the study.
Where this trial is running
Cassino, FR and 1 other locations
- San Raffaele Cassino — Cassino, Fr, Italy (Not_yet_recruiting)
- IRCCS San Raffaele Roma — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Prof. Marco Franceschini, MD — IRCCS San Raffaele Roma
- Study coordinator: Dr. Sanaz Pournajaf, DPT
- Email: sanaz.pournajfa@sanraffaele.it
- Phone: +39 0652252405
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.