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
IRCCS San Raffaele Roma
40 participants
Dec 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria4
- 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.
Interventions
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.
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.
Locations(2)
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NCT06906679