This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period.
The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments.
Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.
Age ≥ 18 years;
First-ever unilateral ischemic or hemorrhagic stroke;
Presence of upper limb motor impairment;
Modified Ashworth Scale (MAS) < 3;
Diagnosis of severe aphasia, based on medical records, preventing participation;
Bilateral hemisphere lesions;
Severe and unstable medical conditions (e.g. untreated seizure, heart failure) that preclude participation in rehabilitation;
Other neurological and/or psychiatric diseases;
Adult PwS admitted to the Intensive Rehabilitation Unit at Fiorenzuola d'Arda hospital. Sampling will be consecutive and carried out on the basis of feasibility and the flow of admissions to the Clinical Unit, amounting to approximately 3-5 individuals per month. The study will include PwS who meet eligibility criteria at the time of recruitment and who are able to understand and provide informed consent to participate.
Cohort
Prospective
Technology-based UL rehabilitation
DeviceParticipants will receive conventional treatments, including neuromotor, occupational therapy, speech therapy and/or neuropsychology treatments, as clinically indicated. In addition, they will undergo a personalized and specific UL technology-based rehabilitation programme, delivered 3 times per week, for a total of 12 - 15 sessions. Each session will last 1 hour and will be conducted in a 1:1 format (physiotherapist : participant). Data on rehabilitation dosage will be collected, including the total number of hours of rehabilitation received. Physiotherapists who will have in charge participant, will compiled a treatment diary for each technology session in which they will record: number of session, total hour of technology-based treatments, type of device used and any adverse events.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is an ordinal scale used to assess sensorimotor function following stroke. The upper extremity motor function section includes four subscales assessing synergistic and non-synergistic movements of shoulder, elbow, wrist and hand, as well as coordination/speed. The maximum score is 66 points, indicating normal upper limb motor function. In addition to motor function, the FMA-UE assesses Non-motor domains (i.e., sensation, passive joint movement and pain), with a maximum total score of 60 points.
Action Research Arm Test (ARAT)
Action Research Arm Test (ARAT) consists of 19 items grouped in subtests (i.e., grasp, grip, pinch, and gross arm movement) and performance of each item rated on a 4 points scale (from 0 - no movement possible, to 3 - movement performed normally.
Instrumented Active Range of Motion (AROM) of affected Upper Limb
The instrumental assessment of the Active Range of Motion (AROM) of the upper limb includes shoulder flexion-extension/abduction and adduction, elbow flexion-extension, wrist flexion-extension/ulnar-radial deviation, and forearm pronation-supination. This will be performed using three inertial sensors located within the PABLO device (Tyromotion, AU)
Instrumental gross and fine motor grip strength of hand affected
The instrumental assessment of the Gross and fine motor grip strength of hand affected includes grasping and releasing, pincer grip, three-finger grip, lateral grip and interdigital grip. This will be performed using Handesensor within the PABLO device (Tyromotion, AU)
National Institute of Health Stroke Scale Italian version (NIHSS-IT)
NIHSS-IT is a standardized ordinal scale determining stroke severity. The scale includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment item is scored ranging from 0 to 2, or 0 to 3 or 0 to 4, depending on the specific domain assessed. The total score results from the sum of all item scores and range from 0 to 42, where 0 indicates the absence of impairments, whereas 42 reflects the most severity stroke.
Oxford Community Stroke Project (OCSP)
OCPS is a clinical classification used to predict the lesion site after stroke. The scale identifies 4 subgroups of cerebral infarction: 1. Total Anterior Cerebral Infarction (TACI): cortical and subcortical involvement; 2. Partial Anterior Cerebral Infarction (PACI): predominantly cortical involvement; 3. Posterior Circulation Infarcts (POCI): vertebrobasilar territory involvement; 4. Lacunar Infarcts (LACI): deep perforating arteries territory involvement.
Modified Ashworth Scale (MAS)
It is a clinical scale to assess muscle tone during passive mobilization. The score ranges from 0 (no muscle tone increase) to 4 (spasticity). In this study it will be evaluated only for biceps brachii and flexor carpi.
Montreal Cognitive Assessment (MoCA)
It is a screening tool used to assess the following cognitive domains: short-term memory, visuospatial abilities, executive functions, attention and concentration, language and orientation. Score ranges from 0 (severe cognitive impairment) to 30 points (normal cognitive function). MoCA is used as an inclusion criteria, with a cut-off score of 24, indicating no more than Mild Cognitive Impairment (MCI).
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