The Implementation of PREP2 Algorithm Into Clinical Practice (PRESTO)
Primary Purpose
Stroke, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PREP2 algorithm
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring rehabilitation efficiency, PRESTO algorithms, physical rehabilitation, stroke, motion kinematics, brain activity
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.
Sites / Locations
- Department of Neuroscience and Rehabilitation, University Hospital of FerraraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Implementation Group
Control Group
Arm 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.
This group will not received any information on the PREP2
Outcomes
Primary Outcome Measures
Rehabilitation LOS (days)
Length of stay as measure of rehabilitation efficiency
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.
Change in Rehabilitation Complexity Scale between two time points
Measure of the complexity of rehabilitation needs and/or interventions.
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.
Change in Action Research Arm Test between three time points
To assess upper extremity performance (coordination, dexterity and functioning)
Change in Fugl-Meyer Assessment between three time points
To assess the sensorimotor impairment in individuals who have had stroke.
Change in Stroke Impact Scale 3.0 between three time points
To evaluate how stroke has impacted your health and life.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04637984
First Posted
October 29, 2020
Last Updated
May 24, 2022
Sponsor
University Hospital of Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT04637984
Brief Title
The Implementation of PREP2 Algorithm Into Clinical Practice
Acronym
PRESTO
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
December 21, 2022 (Anticipated)
Study Completion Date
May 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation
Keywords
rehabilitation efficiency, PRESTO algorithms, physical rehabilitation, stroke, motion kinematics, brain activity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implementation Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not received any information on the PREP2
Intervention Type
Behavioral
Intervention Name(s)
PREP2 algorithm
Intervention Description
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 Outcome Measure Information:
Title
Rehabilitation LOS (days)
Description
Length of stay as measure of rehabilitation efficiency
Time Frame
Hospital discharge (an average of 3-6 months)
Title
Change in Functional International Measure between two time points
Description
Measure of efficiency of rehabilitation. Assess a patient's level of disability as well as change in patient status in response to rehabilitation.
Time Frame
Baseline, hospital discharge (an average of 3-6 months)
Title
Change in Rehabilitation Complexity Scale between two time points
Description
Measure of the complexity of rehabilitation needs and/or interventions.
Time Frame
Baseline, hospital discharge (an average of 3-6 months)
Title
Change in Rehabilitation strategies between two time points
Description
Will be assessed tracking: therapists confidence about patients' recovery (0-5 Likert scale); therapy content; therapy duration.
Time Frame
Baseline, week 4
Title
Change in Action Research Arm Test between three time points
Description
To assess upper extremity performance (coordination, dexterity and functioning)
Time Frame
week 4, 12, week 26
Title
Change in Fugl-Meyer Assessment between three time points
Description
To assess the sensorimotor impairment in individuals who have had stroke.
Time Frame
week 4, 12, week 26
Title
Change in Stroke Impact Scale 3.0 between three time points
Description
To evaluate how stroke has impacted your health and life.
Time Frame
week 4, 12, week 26
Title
Change in Electroencephalography power in beta band between three time points
Description
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Time Frame
week 4, week 12, week 26
Title
Change in Electroencephalography power in alpha band between three time points
Description
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Time Frame
week 4, week 12, week 26
Title
Change in Kinematic data recordings between three time points
Description
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.
Time Frame
week 4, week 12, week 26
Secondary Outcome Measure Information:
Title
Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.
Description
Self-report questionnaire using a Visual Analogue Scale (0 - Strongly disagree; 10 - Strongly agree). Higher score indicates greater satisfaction with the treatment.
Time Frame
week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD, PhD
Phone
0532238720
Email
s.straudi@ospfe.it
Facility Information:
Facility Name
Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Phone
0532236185
Email
s.straudi@ospfe.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alessandro De Vito, MD
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PhD
First Name & Middle Initial & Last Name & Degree
Ilaria Casetta, MD
First Name & Middle Initial & Last Name & Degree
Giada Milani, Psy
First Name & Middle Initial & Last Name & Degree
Michela Cosma, MD
First Name & Middle Initial & Last Name & Degree
Giovanni Ferraresi, PT
First Name & Middle Initial & Last Name & Degree
Monica Morelli, PT
First Name & Middle Initial & Last Name & Degree
Giulia Fregna, MS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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