Actively Recruiting
Upper Limb Rehabilitation in People With Parkinson's Disease:
Led by IRCCS San Raffaele Roma · Updated on 2025-04-04
40
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele Roma
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups: A - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation. Secondary objectives include: \- Evaluating the effectiveness of an end-effector robotic system in terms of improving upper limb coordination and functionality through the ARAT test and the UPDRS. Identifying subgroups of participants who may benefit more from robotic therapy based on PD disease stage (Hoehn \& Yahr), age, and upper limb impairment. Analyzing the effects of robotic rehabilitation on quality of life. Assessing participants' compliance and satisfaction levels with the robotic system in terms of improving participation in upper limb rehabilitation.
CONDITIONS
Official Title
Upper Limb Rehabilitation in People With Parkinson's Disease:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 654 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
San Raffaele Cassino
Cassino, FR, Italy, 03043
Not Yet Recruiting
2
IRCCS San Raffaele Roma
Rome, Lazio, Italy, 00163
Actively Recruiting
Research Team
D
Dr. Sanaz Pournajaf, DPT
CONTACT
D
Dr. Carrie Louise Thouant, OT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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