The Implementation of PREP2 Algorithm Into Clinical Practice

NCT ID: NCT04637984

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2022-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PREP2 algorithm

Intervention Type: 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.

Control Group

This group will not received any information on the PREP2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Ferrara, Emilia-Romagna, Italy

Countries

Italy

Other Identifiers

Predict_stroke_outcomes

Identifier Type: -

Identifier Source: org_study_id