Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

The Fugl-Meyer Assessment (FMA) is a widely used clinical tool to assess motor recovery in individuals who have experienced a stroke. It is designed to measure motor function, sensory function, balance, and joint range of motionin individuals with hemiplegia (one-sided paralysis or weakness), which is common following a stroke.

The Oxford Cognitive Screen (OCS) assesses key cognitive domains: memory, language, numerical cognition, praxis, executive functions, and attention. It is designed as a screening tool that enables a rapid evaluation of the patient's cognitive functioning and guides further, more detailed assessment of any impaired cognitive domain(s). It also allows for the evaluation of aphasic patients. Test items are presented both visually and verbally, with the option to select a correct response from multiple choices. To optimize the distribution of attentional resources, the battery items are presented centrally, reducing the need for visual scanning. The OCS allows for the assessment of neglect (both allocentric and egocentric), apraxia, and deficits in numerical cognition.

The Modified Ashworth Scale (MAS) is used to assess spasticity. The Modified Ashworth Scale (MAS) has been utilised in the following populations: stroke, spinal cord injury, multiple sclerosis, cerebral palsy, traumatic brain injury, paediatric hypertonia and central nervous system lesions. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Scores range from 0 to 4, where 0 indicates no increase in muscle tone and 4 represents a limb that is rigid in flexion or extension. The score from 0 to 4 indicated in the title refers to the individual joint. Specifically, in this study, the muscle tone of the shoulder, elbow, and wrist will be assessed.

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It can be used with a wide range of populations, including clients with stroke.The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.

The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. The Nine-Hole Peg Test is administered by asking the client to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container.Scores are based on the time taken to complete the activity, recorded in seconds.

The ABILHAND is an interview-based assessment of a patient-reported measure of the perceived difficulty in using their hand to perform manual activities in daily activities. The assessment considers the active function of the upper limbs and measures the ability to perform bimanual tasks, regardless of the way in which these tasks are carried out. There are currently versions specifically validated for Chronic stroke, Rheumatoid Arthritis, Systemic sclerosis, Hand Surgery. This is an interview-based assessment where patient is asked to estimate the ease or difficulty of performing a list of activities when carried out without assistance. This can involve any strategy used to carry out the activity, and is self-report and not a physical demonstration of the activity.

The questionnaire is downloaded from the website and one of the 10 random orders of questions. These are read to the patient and scored as either "impossible", "difficult" or "easy". If a task has not been attempted

The modified Barthel Index (mBI) is a well-established patient-centered outcome measure commonly administrated in rehabilitation settings to evaluate the functional status of patients at admission and discharge.

The Client Satisfaction Questionnaire (CSQ-8) is one of a limited number of standardised satisfaction measures that have been used widely across mental health services.

The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living (IADL) for use with patients recovering from stroke. The FAI assesses a broad range of activities associated with everyday life that patient has participated in within the recent past, broken into 3 domains: domestic chores, leisure/work, and outdoor activities. The items included move beyond the scope of ADL scales, which tend to focus on issues related to self care and mobility.

Can be separated into 3 domains:

• Domestic chores
• Leisure/work
• Outdoor activities The frequency with which each item or activity is undertaken over the past 3-6 months (depending on the nature of the activity) is assigned a score of 1 - 4 where a score of 1 is indicative of the lowest level of activity.

The scale provides a summed score from 15 - 60.

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. It has two, 4-item, optional modules used to measure symptoms and function in athletes, artists, and workers who require a high level of function.

Utilizes a 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks.

Total scores range from 0 (minimum) to (100) maximum.

A robotic assessment will be performed only for the subjects in the GS group. The robotic device used in the study allows for the evaluation of: Preliminary measurement of the force exerted by the patient during each movement (isometric contraction); Pre-post measurements of the active Range of Motion (ROM) in the patient's 3D working area and of all the individual joints of the affected arm (constrained joints); Movement precision pre-post (speed peaks recorded during exercises).

In a subgroup of GS subjects (neurophysiological pilot study), instrumental assessments of neurophysiological signals will also be performed at centers equipped with the appropriate instruments.

Surface electromyography (sEMG) and kinematics (stereophotogrammetric system with the RAB protocol) will be recorded during the execution of a standardized motor task (Reaching).

Electroencephalography (EEG): Brain electrical activity will be recorded from 120 channels during rest conditions with eyes closed and open (5 minutes each). The frequency bands considered will be delta (2-4 Hz), theta (4-8 Hz), Alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), beta2 (20-30 Hz), and gamma (30-40 Hz). The activation current density of cortical sources and brain connectivity will be calculated with the eLORETA software for both hemispheres. Specific networks related to the task performed and the lesioned areas will also be analyzed.

Instrumental assessment of manual dexterity will be conducted using a sensorized and modified version of the Box and Block Test (BBT). This modified version involves moving 10 cubes from one side of the box to the other positioned on a 5x2 grid. In a subset of EG subjects, kinematic parameters will be measured using Inertial Measurement Units (IMUs), and electrophysiological parameters will be recorded via surface electromyography (sEMG). The assessment will quantify joint kinematics, including range of motion and movement smoothness, as well as upper limb muscle activation patterns, such as muscle onset timing and co-contraction levels. This approach enables a comprehensive evaluation of motor performance during the BBT.