The Implementation of PREP2 Algorithm Into Clinical Practice

NCT04637984 | Completed DMC

• 1 other identifier: Predict_stroke_outcomes
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation

Keywords

rehabilitation efficiency; PRESTO algorithms; physical rehabilitation; stroke; motion kinematics; brain activity

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.

  week 4

Study Arms (2)

Implementation Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

This group will not received any information on the PREP2

Interventions

PREP2 algorithm BEHAVIORAL

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.

Implementation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stroke;
• new upper and/or lower limb weakness.

You may not qualify if:

• cerebellar or bilateral stroke;
• contraindication to TMS;
• cognitive or communication impairment precluding informed consent;
• assisted walking prior to admission;
• severe medical conditions.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 20, 2020
• Study Start: May 27, 2019
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

IT (1)