StrokePRESTONCT04637984

The Implementation of PREP2 Algorithm Into Clinical Practice

A study testing PREP2 algorithm in people with Stroke and Rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Rehabilitation
What is being tested?: PREP2 algorithm
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteItaly
Study dates: 27 May 2019to 20 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of stroke;
new upper and/or lower limb weakness.

Who cannot join

cerebellar or bilateral stroke;
contraindication to TMS;
cognitive or communication impairment precluding informed consent;
assisted walking prior to admission;
severe medical conditions.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
Ferrara, Emilia-Romagna, 44124

Other trials in Italy

About this study

Official 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

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
Being tested: PREP2 algorithm
Keywords: rehabilitation efficiency, PRESTO algorithms, physical rehabilitation, stroke, motion kinematics, brain activity
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PREP2 algorithmBehavioural
1. 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.

Study groups in NCT04637984
Study group	Role	What they receive
Implementation Group	Experimental	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. Receives: Behavioral: PREP2 algorithm
Control Group	No intervention	This group will not received any information on the PREP2

What is being measured

The primary outcome is the main question the study is designed to answer.

Rehabilitation LOS (days)
Length of stay as measure of rehabilitation efficiency
Measured: Hospital discharge (an average of 3-6 months)
Change in Functional International Measure between two time points
Measure of efficiency of rehabilitation. Assess a patient's level of disability as well as change in patient status in response to rehabilitation.
Measured: Baseline, hospital discharge (an average of 3-6 months)
Change in Rehabilitation Complexity Scale between two time points
Measure of the complexity of rehabilitation needs and/or interventions.
Measured: Baseline, hospital discharge (an average of 3-6 months)
Change in Rehabilitation strategies between two time points
Will be assessed tracking: therapists confidence about patients' recovery (0-5 Likert scale); therapy content; therapy duration.
Measured: Baseline, week 4
Change in Action Research Arm Test between three time points
To assess upper extremity performance (coordination, dexterity and functioning)
Measured: week 4, 12, week 26
Change in Fugl-Meyer Assessment between three time points
To assess the sensorimotor impairment in individuals who have had stroke.
Measured: week 4, 12, week 26
Change in Stroke Impact Scale 3.0 between three time points
To evaluate how stroke has impacted your health and life.
Measured: week 4, 12, week 26
Change in Electroencephalography power in beta band between three time points
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Measured: week 4, week 12, week 26
Change in Electroencephalography power in alpha band between three time points
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Measured: week 4, week 12, week 26
Change in Kinematic data recordings between three time points
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.
Measured: week 4, week 12, week 26

Secondary outcomes (1)

Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.
Self-report questionnaire using a Visual Analogue Scale (0 - Strongly disagree; 10 - Strongly agree). Higher score indicates greater satisfaction with the treatment.
Measured: week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 201920 Dec 2022

First posted20 Nov 2020
Study start27 May 2019
Primary completion20 Dec 2022
Study completion20 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04637984
Sponsor's protocol ID: Predict_stroke_outcomes
Acronym: PRESTO
Status last verified: Sep 2025
First submitted: 29 Oct 2020
Last updated: 6 Oct 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
RecruitingPhase 3
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04637984
Acronym / sponsor ID: PRESTO / Predict_stroke_outcomes
Conditions: Stroke, Rehabilitation
Keywords: rehabilitation efficiency, PRESTO algorithms, physical rehabilitation, stroke, motion kinematics, brain activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University Hospital of FerraraUniversity, hospital or other
Study start: 27 May 2019 (actual)
Primary completion: 20 Dec 2022 (actual)
Study completion: 20 Dec 2022 (actual)
First posted: 20 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Implementation Group	Experimental	Behavioral: PREP2 algorithmPredictions 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.
Control Group	No intervention	–This group will not received any information on the PREP2

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

diagnosis of stroke;
new upper and/or lower limb weakness.

Key exclusion criteria (5 listed)

cerebellar or bilateral stroke;
contraindication to TMS;
cognitive or communication impairment precluding informed consent;
assisted walking prior to admission;
severe medical conditions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PREP2 algorithmA) 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.	Behavioural	Implementation Group

Primary outcome

Rehabilitation LOS (days)
Time frame: Hospital discharge (an average of 3-6 months)
Length of stay as measure of rehabilitation efficiency
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.
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.
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.
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)
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.
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.
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.
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.
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.

1 secondary outcome

Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.
Time frame: week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
Individual participant dataSharing planned: Undecided

Related trials for Stroke

Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
RecruitingPhase 3
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PREP2 algorithm in people with Stroke and Rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rehabilitation LOS (days) (time frame: Hospital discharge (an average of 3-6 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04637984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025; AzTrials last refreshed its copy on 28 Oct 2026.