PROFITS - Precision profiling to improve long-term outcome after stroke

PROFITS - Precision profiling to improve long-term outcome after stroke - PROFITS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44838

Enrollment

160

Registered

2016-01-28

Start date

2016-08-23

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVA stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Acute Stroke age > 18 able to sit for at least 30 minutes with backsupport upper limb paresis or lower limb paresis sufficient cognitive functioning

Exclusion criteria

Exclusion criteria: >3 week post stroke pacemaker or other metallic implants (for the subset of patients subjected to the EEG measurements).

Design outcomes

Primary

Measure	Time frame
Motor recovery at 3 and 6 months post stroke, in terms of restitution (primary neurological repair) using the Fugl Meyer arm and leg score and substitution (added- up with compensatory strategies to assess functional recovery) using the Action Research Arm Test.	—

Secondary

Measure	Time frame
Not all participating centers will measure the full set of outcomes. They will only measure the primary outcomes. Demographics and phenotype of patients: Birth date Gender Stroke Type (Bamford classification) Hemispheric dominance and hand dexterity (Edinburgh Handiness Inventory) Date CVA Date Hospitalization Date discharge rTPA treatment Trombectomy therapy Comorbidity (CIRS scale) * History of myocardial infarction * History of hypertension * History of diabetes mellitus * History of hypercholesterolemia * History of atrial fibrillation * Body Mass Index * Smoking * Alcohol use * Concomitant neurological, orthopedic, internal disease or condition Complications acute phase (within 24 hours after stroke) Complications sub-acute phase (24 hours-hospital discharge) Family history cardiovascular diseases Vital signs (RR, pulse at admission) Medication before admission Medication at discharge Risk factors - Prior stroke - Prior myocardinfarct - Hypertension - Diabetes mellitus - Hyperlipidemia - Atrial fibrillation - Body Mass Index - Smoking status - Alcohol use - Family history of coronary artery diseases Premorbid functioning: Functional Ambulatory Categories Modified Ranking Scale Barthel Index Social status: * Employment * Profession * Education * Sport activities * Hobbies * Marital status * Children * Burden and capacity/health status of partner * Employment/profession of partner Neurological status: National Institute of Health Stroke Scale Brunnström Fugl-Meyer assessment for synergy of the upper and lower extremit Finger extension Motricity Index-arm and leg O-Letter Cancellation Test Montreal Cognitive Assessment Erasmus MC Modification of the (revised) Nottingham Sensory Assessment Standardized Swallowing Assessment Frenchay Aphasia Screening Test Trunk control test Frenchay Arm Test Activities and participation: Barthel Index Functional Ambulatory Categories Modified Ranking Scale Berg Ba	—

Measure

Time frame

Not all participating centers will measure the full set of outcomes. They will only measure the primary outcomes. Demographics and phenotype of patients: Birth date Gender Stroke Type (Bamford classification) Hemispheric dominance and hand dexterity (Edinburgh Handiness Inventory) Date CVA Date Hospitalization Date discharge rTPA treatment Trombectomy therapy Comorbidity (CIRS scale) * History of myocardial infarction * History of hypertension * History of diabetes mellitus * History of hypercholesterolemia * History of atrial fibrillation * Body Mass Index * Smoking * Alcohol use * Concomitant neurological, orthopedic, internal disease or condition Complications acute phase (within 24 hours after stroke) Complications sub-acute phase (24 hours-hospital discharge) Family history cardiovascular diseases Vital signs (RR, pulse at admission) Medication before admission Medication at discharge Risk factors - Prior stroke - Prior myocardinfarct - Hypertension - Diabetes mellitus - Hyperlipidemia - Atrial fibrillation - Body Mass Index - Smoking status - Alcohol use - Family history of coronary artery diseases Premorbid functioning: Functional Ambulatory Categories Modified Ranking Scale Barthel Index Social status: * Employment * Profession * Education * Sport activities * Hobbies * Marital status * Children * Burden and capacity/health status of partner * Employment/profession of partner Neurological status: National Institute of Health Stroke Scale Brunnström Fugl-Meyer assessment for synergy of the upper and lower extremit Finger extension Motricity Index-arm and leg O-Letter Cancellation Test Montreal Cognitive Assessment Erasmus MC Modification of the (revised) Nottingham Sensory Assessment Standardized Swallowing Assessment Frenchay Aphasia Screening Test Trunk control test Frenchay Arm Test Activities and participation: Barthel Index Functional Ambulatory Categories Modified Ranking Scale Berg Ba

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Countries

Netherlands

Outcome results