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The Implementation of PREP2 Algorithm Into Clinical Practice

NCT04637984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-10-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04637984 on ClinicalTrials.gov