RecruitingNot ApplicableNCT06906679

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

Sponsor

IRCCS San Raffaele Roma

Enrollment

40 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an upper limb rehabilitation program for people with Parkinson's disease to help improve arm strength, coordination, and fine motor skills — which are commonly affected as the disease progresses. **You may be eligible if...** - You are between 30 and 80 years old - You have been diagnosed with Parkinson's disease based on established clinical criteria - Your disease is at a moderate stage (Hoehn and Yahr score of 2–3 when your medication is working) - Your memory and thinking are adequate for participation (MoCA score ≥ 17.54) - Your medication has been stable for at least the past 4 weeks **You may NOT be eligible if...** - You are unable or unwilling to follow the exercise program - You have another neurological condition, significant psychiatric problems, or a bone or muscle condition that would prevent arm exercises - Your Parkinson's is too advanced to benefit from the program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental Group

The EG will follow 20 sessions of robot-assisted therapy for the upper limb. Exercises will be performed using a handpiece to support the weight of the upper limb during therapy and to assist (or resist) movements according to the patient's needs. These modalities are presented to the patient through visual and motor feedback (force feedback). The exercises will focus on rehabilitating upper limb performance, for example: Elbow: flexion-extension; Shoulder: horizontal adduction/abduction, flexion-extension. The software includes serious games for: * Motor control (both movement control and force control); * Coordination; * Cognitive training; * Simulation of daily activities. The exercises will be defined by specialized personnel based on the patient's characteristics. Each rehabilitation session lasts 45 minutes, including 5 minutes for device setup, 20 minutes for the right upper limb and 20 minutes for the left upper limb.

OTHERcontrol group

The CG will last 20 sessions (3 days/week) of conventional rehabilitative treatment without the use of technological devices for the upper limb. Each session will last 45 minutes. The motor exercises will focus on upper limb rehabilitation and will be performed with a therapist who will personalize the treatment based on the patient's characteristics and needs. Specifically, the upper limb treatment will include exercises for mobility (shoulder, elbow, wrist, and hand), coordination, and manual dexterity.