Clinical trial NCT04637984: The Implementation of PREP2 Algorithm Into Clinical Practice
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: rehabilitation efficiency
PRESTO algorithms
physical rehabilitation
stroke
motion kinematics
brain activity
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Rehabilitation LOS (days)
timeFrame: Hospital discharge (an average of 3-6 months)
measure: Change in Functional International Measure between two time points
timeFrame: Baseline, hospital discharge (an average of 3-6 months)
measure: Change in Rehabilitation Complexity Scale between two time points
timeFrame: Baseline, hospital discharge (an average of 3-6 months)
measure: Change in Rehabilitation strategies between two time points
timeFrame: Baseline, week 4
measure: Change in Action Research Arm Test between three time points
timeFrame: week 4, 12, week 26
measure: Change in Fugl-Meyer Assessment between three time points
timeFrame: week 4, 12, week 26
measure: Change in Stroke Impact Scale 3.0 between three time points
timeFrame: week 4, 12, week 26
measure: Change in Electroencephalography power in beta band between three time points
timeFrame: week 4, week 12, week 26
measure: Change in Electroencephalography power in alpha band between three time points
timeFrame: week 4, week 12, week 26
measure: Change in Kinematic data recordings between three time points
timeFrame: week 4, week 12, week 26
Secondary outcomes:
measure: Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.
timeFrame: week 4
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
state: Emilia Romagna
Study officials:
References: