Actively Recruiting

Phase Not Applicable
Age: 30Years - 80Years
All Genders
NCT06906679

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

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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