The Implementation of PREP2 Algorithm Into Clinical Practice (PRESTO)

University Hospital of Ferrara

Status: Completed

Conditions: Rehabilitation; Stroke

Treatments: Behavioral: PREP2 algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT04637984

Predict_stroke_outcomes

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Implementation Group

Experimental group

Description:

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.

Treatment:

Behavioral: PREP2 algorithm

Control Group

No Intervention group

Description:

This group will not received any information on the PREP2