Stroke is a worldwide major cause of disability with great social and economic burdens. The recovery of motor function is crucial for the patient to regain independence and quality of life. Identifying early predictors of motor recovery and outcomes is useful for planning personalized rehabilitation programs and increasing their efficiency. However, making predictions using a single clinical assessment is often difficult and a combination of multiple tools is required. In the last decades, were validated two predictive algorithms for upper limb function and independent walking that can be easily implemented into clinical practice with the aim of increasing knowledge on expected outcome after stroke in patients, families and rehabilitation teams. This will be the first single-site randomized control trial that will test the implementation of such tools in a rehabilitation setting in Italy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
200
A) PREP2. It combines clinical measures and neurological biomarkers in the initial days after stroke: 1) SAFE score (day 3), which is the sum of shoulder abduction and finger extension strength in the paretic upper limb using the Medical Research Council (MRC); 2) NIH Stroke Scale (day 3); 3) transcranial magnetic stimulation (day 3-7) to determine the presence of MEPs in the paretic arm. According with the aforementioned measures, 4 categories of upper limb recovery will be identified: EXCELLENT, GOOD, LIMITED and POOR.
Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
Ferrara, Emilia-Romagna, Italy
Rehabilitation LOS (days)
Length of stay as measure of rehabilitation efficiency
Time frame: Hospital discharge (an average of 3-6 months)
Change in Functional International Measure between two time points
Measure of efficiency of rehabilitation. Assess a patient's level of disability as well as change in patient status in response to rehabilitation.
Time frame: Baseline, hospital discharge (an average of 3-6 months)
Change in Rehabilitation Complexity Scale between two time points
Measure of the complexity of rehabilitation needs and/or interventions.
Time frame: Baseline, hospital discharge (an average of 3-6 months)
Change in Rehabilitation strategies between two time points
Will be assessed tracking: therapists confidence about patients' recovery (0-5 Likert scale); therapy content; therapy duration.
Time frame: Baseline, week 4
Change in Action Research Arm Test between three time points
To assess upper extremity performance (coordination, dexterity and functioning)
Time frame: week 4, 12, week 26
Change in Fugl-Meyer Assessment between three time points
To assess the sensorimotor impairment in individuals who have had stroke.
Time frame: week 4, 12, week 26
Change in Stroke Impact Scale 3.0 between three time points
To evaluate how stroke has impacted your health and life.
Time frame: week 4, 12, week 26
Change in Electroencephalography power in beta band between three time points
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Time frame: week 4, week 12, week 26
Change in Electroencephalography power in alpha band between three time points
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Time frame: week 4, week 12, week 26
Change in Kinematic data recordings between three time points
Kinematic data of trunk and affected hand will be recorded during subject imitations. Kinematic data will be recorded with the aim of characterizing the PREP2 recovery classes.
Time frame: week 4, week 12, week 26
Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.
Self-report questionnaire using a Visual Analogue Scale (0 - Strongly disagree; 10 - Strongly agree). Higher score indicates greater satisfaction with the treatment.
Time frame: week 4
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