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Completed

NCT Number: NCT04637984

The Implementation of PREP2 Algorithm Into Clinical Practice

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Rehabilitation Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rehabilitation LOS (days)

    Time frame: Hospital discharge (an average of 3-6 months)

    Length of stay as measure of rehabilitation efficiency

  2. Change in Functional International Measure between two time points

    Time frame: Baseline, hospital discharge (an average of 3-6 months)

    Measure of efficiency of rehabilitation. Assess a patient's level of disability as well as change in patient status in response to rehabilitation.

  3. Change in Rehabilitation Complexity Scale between two time points

    Time frame: Baseline, hospital discharge (an average of 3-6 months)

    Measure of the complexity of rehabilitation needs and/or interventions.

  4. Change in Rehabilitation strategies between two time points

    Time frame: Baseline, week 4

    Will be assessed tracking: therapists confidence about patients' recovery (0-5 Likert scale); therapy content; therapy duration.

  5. Change in Action Research Arm Test between three time points

    Time frame: week 4, 12, week 26

    To assess upper extremity performance (coordination, dexterity and functioning)

  6. Change in Fugl-Meyer Assessment between three time points

    Time frame: week 4, 12, week 26

    To assess the sensorimotor impairment in individuals who have had stroke.

  7. Change in Stroke Impact Scale 3.0 between three time points

    Time frame: week 4, 12, week 26

    To evaluate how stroke has impacted your health and life.

  8. Change in Electroencephalography power in beta band between three time points

    Time frame: week 4, week 12, week 26

    EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.

  9. Change in Electroencephalography power in alpha band between three time points

    Time frame: week 4, week 12, week 26

    EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.

  10. Change in Kinematic data recordings between three time points

    Time frame: week 4, week 12, week 26

    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.

Secondary outcomes

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

    Time frame: week 4

    Self-report questionnaire using a Visual Analogue Scale (0 - Strongly disagree; 10 - Strongly agree). Higher score indicates greater satisfaction with the treatment.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Acronym: PRESTO

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2020
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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