The Implementation of PREP2 Algorithm Into Clinical Practice

Not Applicable

• Conditions: Rehabilitation; Stroke

• Registration Number: NCT04637984
• Lead Sponsor: University Hospital of Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-27
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-12-21
• Study Completion: 2023-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara; 🇮🇹 Ferrara, Emilia Romagna, Italy