NCT06906679 Upper Limb Rehabilitation in People With Parkinson's Disease:
| NCT ID | NCT06906679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-12-20 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Prof. Marco Franceschini, MD
STUDY CHAIR
IRCCS San Raffaele Roma
Frequently Asked Questions
Who can join the NCT06906679 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906679 currently recruiting?
Yes, NCT06906679 is actively recruiting participants. Contact the research team at sanaz.pournajfa@sanraffaele.it for enrollment information.
Where is the NCT06906679 trial being conducted?
This trial is being conducted at Cassino, Italy, Rome, Italy.
Who is sponsoring the NCT06906679 clinical trial?
NCT06906679 is sponsored by IRCCS San Raffaele Roma. The principal investigator is Prof. Marco Franceschini, MD at IRCCS San Raffaele Roma. The trial plans to enroll 40 participants.
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