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NCT06906679Completed

Upper Limb Rehabilitation in 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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
42 (actual)
First submitted
26 Mar 2025
Start date
20 Dec 2023
Primary completion date
14 Oct 2026
Lead sponsor
IRCCS San Raffaele Roma
NCT number
NCT06906679

What you commit to

  • Study type: Interventional
  • Participants enrolled: 42
  • From 20 Dec 2023 to the primary completion date, 14 Oct 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders;
  • Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility;

Other

  • Unable to adhere to the exercise program due to poor compliance;
  • Participants who have not signed the informed consent for the study.

Who the study is looking for

  • 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.

Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Raffaele Cassino
Coordinator of this site? Confirm its status
CassinoItalyUnknown status
IRCCS San Raffaele Roma
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.