Upper Limb Rehabilitation in People With Parkinson's Disease:
Recruiting · NCT06906679 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS San Raffaele Roma
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
2 locations listed.
- San Raffaele Cassino - Cassino, FR, Italy
- IRCCS San Raffaele Roma - Rome, Lazio, Italy