The Implementation of PREP2 Algorithm Into Clinical Practice

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Implementation of PREP2 Algorithms Into Clinical Practice: a Strategy for Improving Rehabilitation Efficiency and Clinical Outcomes After Stroke. A Single-site Randomized Control Trial

Conditions
-----------------
Stroke, Rehabilitation

Intervention / Treatment
-----------------
* Behavioral: PREP2 algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of stroke; new upper and/or lower limb weakness. Exclusion Criteria: cerebellar or bilateral stroke; contraindication to TMS; cognitive or communication impairment precluding informed consent; assisted walking prior to admission; severe medical conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation Group<br>Predictions will be provided to the rehabilitation team and discussed with the patient and their family. Patients will receive a multidisciplinary rehabilitation according to their individual needs. | Behavioral: PREP2 algorithm<br>* 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.<br>|
| No Intervention: Control Group<br>This group will not received any information on the PREP2 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation LOS (days) | Length of stay as measure of rehabilitation efficiency | 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. | 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. | 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. | Baseline, week 4 | 
| Change in Action Research Arm Test between three time points | To assess upper extremity performance (coordination, dexterity and functioning) | 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. | 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. | 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. | 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. | 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. | week 4, week 12, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, motion kinematics, brain activity, rehabilitation efficiency, PRESTO algorithms, physical rehabilitation