About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Experimental Group
DeviceThe 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.
control group
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Box 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.
Secondary outcomes
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).
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.
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.
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.
Other outcomes
Montreal Cognitive Assessment (MoCA)
The MoCA is popular screening tool used to determine if cognitive impairment is present. It takes approximately ten minutes to complete. It evaluates visuospatial skills, attention, language, abstract reasoning, delayed recall, executive function, and orientation. The MoCA covers more domains than the MMSE and, as a consequence, has greater sensitivity and specificity. Cognitive assessments are fast, easy-to-use, and accurate ways to help diagnose, evaluate progress, and manage many kinds of cognitive impairments. The MoCA is useful in determining a patient's level of understanding and ability.
Nine Hole Peg Test
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. The administration of the test consists of instructing the patient to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible, using only the hand being evaluated. Then, instruct the patient to remove the pegs from the holes, one by one, and replace them back into the container. The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container. The scoring is calculated as number of seconds it takes for the patient to complete the test. An alternative scoring could be the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second.
Trail Making Test
The Trail Making Test consists of two parts, A and B, each of which must be performed using a pencil. The examiner starts timing parts A and B as soon as they finish giving the instructions and the participant is given the start signal. The stopwatch should not be stopped until the participant has completed each part or the time limit for interruption has been reached. The score is calculated in this way: the time taken for completion must be recorded separately for Parts A and B. The maximum score for Part A is 100", while 101" indicates that the test was interrupted. The maximum score for Part B is 300", while 301" indicates that the test was interrupted.
Sensors-based Pointing Task
The subject sits in front of a target panel (e.g., a touch-screen monitor 24") in order to perform a pointing task evaluation test. The distance between the subject and the center of the panel will be set according to each subject's arm length measured with the fist closed. During the pointing task trials, subjects are invited to reach, at his/her self-selected speed, one of the targets on the monitor, and then return to the initial point (e.g., the trigger-box button). Inertial sensors will be applied to the upper limb and trunk, surface electromyography sensors will be placed on the main muscle groups of the upper limb, and finally, a 128-channel EEG cap will be used.
Sponsors and contacts
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IRCCS San Raffaele Roma
Lead sponsor
Ministry of Health, Italy
Collaborator