The Implementation of PREP2 Algorithm Into Clinical Practice (PRESTO)

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

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 Overview

• Status: Completed
• Conditions: Stroke; Rehabilitation
• Intervention / Treatment: Behavioral: PREP2 algorithm

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44124
      • Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implementation Group; 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; 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.
No Intervention: Control Group; 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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: stroke; brain activity; physical rehabilitation; rehabilitation efficiency; PRESTO algorithms; motion kinematics
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Predict_stroke_outcomes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No