The Implementation of PREP2 Algorithm Into Clinical Practice

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637984
• Other study ID #: Predict_stroke_outcomes
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: May 21, 2023

Study information

• Verified date: May 2022
• Source: University Hospital of Ferrara
• Contact: Sofia Straudi, MD, PhD
• Phone: 0532238720
• Email: s.straudi[@]ospfe.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 21, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Neuroscience and Rehabilitation, University Hospital of Ferrara	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation LOS (days)	Length of stay as measure of rehabilitation efficiency	Hospital discharge (an average of 3-6 months)
Primary	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.	Baseline, hospital discharge (an average of 3-6 months)
Primary	Change in Rehabilitation Complexity Scale between two time points	Measure of the complexity of rehabilitation needs and/or interventions.	Baseline, hospital discharge (an average of 3-6 months)
Primary	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.	Baseline, week 4
Primary	Change in Action Research Arm Test between three time points	To assess upper extremity performance (coordination, dexterity and functioning)	week 4, 12, week 26
Primary	Change in Fugl-Meyer Assessment between three time points	To assess the sensorimotor impairment in individuals who have had stroke.	week 4, 12, week 26
Primary	Change in Stroke Impact Scale 3.0 between three time points	To evaluate how stroke has impacted your health and life.	week 4, 12, week 26
Primary	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.	week 4, week 12, week 26
Primary	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.	week 4, week 12, week 26
Primary	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.	week 4, week 12, week 26
Secondary	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.	week 4