NCT04637984

The Implementation of PREP2 Algorithm Into Clinical Practice

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-27
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2020-11-20
• Last updated: 2025-10-06

Locations

1 site across 1 country: Italy