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.
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting over 6 million individuals worldwide, with its prevalence having increased 2.5 times in the last 30 years, making it a leading cause of neurological disability. The hallmark of PD is a motor syndrome characterized by bradykinesia, resting tremor, and rigidity, alongside postural and gait alterations. Despite being considered a movement disorder, PD often presents non-motor symptoms like hyposmia, constipation, urinary dysfunction, orthostatic hypotension, cognitive impairments, mood depression, pain, and sleep disorders. Motor symptoms progressively impair daily activities and reduce quality of life, with difficulties in gait and swallowing worsening disability over time. Specifically, upper limb motor dysfunction is marked by reduced movement speed and impaired force modulation, leading to poor hand movement quality. Motor impairment in PD is inversely correlated with movement speed and directly correlated with task complexity. PD progresses slowly, and while current treatments manage motor symptoms effectively in the early stages, their efficacy diminishes in advanced stages, with non-motor symptoms becoming more evident. Alongside pharmacotherapy, early and regular physical rehabilitation has shown benefits, improving motor function, posture control, balance, and strength while potentially delaying disease progression. The success of PD treatment depends on treatment quality, timing, and frequency. Conventional rehabilitation includes exercise, strategy training, and patient education, focusing on enhancing upper limb coordination, fluidity, and dexterity. Although some therapies improve motor function and non-motor symptoms, limited evidence exists regarding their impact on hand dexterity. Robotic devices, leveraging neuroplasticity and motor learning principles, have been integrated into rehabilitation to maximize sensory input and provide targeted, task-specific stimuli to the central nervous system. Advances in technology have made robotic treatments more accessible, complementing traditional physiotherapy, particularly in upper limb neurorehabilitation. Robotic-assisted therapy (RAT) has shown efficacy in stroke rehabilitation, improving upper limb function, spasticity, and daily living activities. However, research on robotic rehabilitation for PD has primarily focused on lower limbs and gait training (RAGT), demonstrating positive effects on motor function and balance, despite limited sample sizes and follow-up studies. Regarding upper limb rehabilitation in PD, evidence is scarce. Some studies using virtual reality systems, like Oculus Rift 2 with Leap Motion Controller (OR2-LMC), have shown improvements in strength, fine and gross dexterity, and movement speed, although discrepancies between qualitative and quantitative results were noted. Picelli et al. (2014) found that robotic-assisted upper limb training improved sensorimotor functions, but the placebo effect cannot be ruled out, emphasizing the need for larger, randomized controlled trials comparing RAT to conventional rehabilitation. More recently, Raciti L. et al. (2022) highlighted the efficacy of the Armeo exoskeleton in enhancing hand function, dexterity, and cognitive abilities, suggesting a promising avenue for PD rehabilitation (32). Given the limited evidence on robotic rehabilitation for upper limb motor disorders in PD, this study aims to evaluate the effectiveness of an end-effector robotic device designed to improve shoulder, elbow, and wrist movements, strength, and coordination in individuals with mild to moderate PD, compared to conventional rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
San Raffaele Cassino
Cassino, FR, Italy
NOT_YET_RECRUITINGIRCCS San Raffaele Roma
Rome, Lazio, Italy
RECRUITINGBox and Block Test (BBT)
Box and Blocks test, BBT, is used to measure a manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. In Box and Blocks test there are test box with 150 blocks and a partition in the middle is placed lengthwise along the edge of a standard-height table. The test taker is instructed to quickly pick up one block at a time with his or her right or left hand. Then carry the box over the partitioned and drop it and it is important for the patient to know that each successful execution is one point and he or she carries two it will be counted as one. The number of blocks that the test taker successfully transferred will becomes the final score and the higher the score the better the gross manual dexterity of the test taker.
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Lyle proposed that this hierarchical ordering would improve efficiency of testing, as normal movement on the most difficult items would be indicative of successful performance on proceeding items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Unified Parkinson's Disease Rating Scale (UPDRS)
Unified Parkinson's Disease Rating Scale (UPDRS) is a rating tool used to gauge the the severity and progression of Parkinson's disease in patients. The UPDRS scale consists of the following six segments: 1. Mentation, Behavior, and Mood; 2. ADL; 3. Motor sections; 4. Complications of Therapy (in the past week); 5. Modified Hoehn and Yahr Scale; 6. Schwab and England ADL scale. The first four segments are made up of 42 items grouped into four subscales. The UPDRS was developed in 1987 as a gold standard by neurologists for monitoring the response to medications used to decrease the signs and symptoms of Parkinson's. Parts 1 to 3 are scored on a 0-4 rating scale. Part 4 is scored with yes and no ratings. Higher scores show increased severity. Then the administrator rates the patient on the H and Y Scale and the Schwab and England Activities of Daily Living Scale.
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Disabilities of the Arm, Shoulder and Hand (DASH)
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The DASH has been translated in many different languages and has demonstrated to be a valid and reliable questionnaire for a variety of upper extremity disorders. High score corresponds to high level of arm disability.
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment), day 140 (FU1 - 3 months after treatment Follow-Up)
Client satisfaction questionnaire
The Client satisfaction questionnaire investigates the subject's overall satisfaction with participating in the study. It consists of six questions with a score ranging from 0 to 4. A high score corresponds to a high level of satisfaction from the subject.
Time frame: Day 50 (T1 - After treatment).
System Usability Scale (SUS)
The System Usability Scale (SUS) is a simple, ten-item scale giving a global view of subjective assessments of usability. SUS is a Likert scale. It is often assumed that a Likert scale is simply one based on forced-choice questions, where a statement is made and the respondent then indicates the degree of agreement or disagreement with the statement on a 5 (or 7) point scale. However, the construction of a Likert scale is somewhat more subtle than this. Whilst Likert scales are presented in this form, the statements with which the respondent indicates agreement and disagreement have to be selected carefully.
Time frame: Day 50 (T1 - After treatment).
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