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Recovery after stroke


- candidate number26982
- NTR NumberNTR6535
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mrt-2017
- Secondary IDsNL54449.078.15 / MEC-2015-687 CCMO / METc Erasmus MC
- Public TitleRecovery after stroke
- Scientific TitlePROFITS - Precision profiling to improve long-term outcome after stroke
- ACRONYMPROFITS
- hypothesis
- Healt Condition(s) or Problem(s) studiedStroke, Prognosis
- Inclusion criteria(1) ischemic or hemorrhagic stroke; (2) upper limb paresis as defined by NIHSS motor arm item 0
- Exclusion criteria(1) more than 3 weeks post stroke; (2) pacemaker or other metallic implants for a subset of subjects (which will participate in the EEG protocol)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 9-sep-2016
- planned closingdate1-nov-2019
- Target number of participants160
- InterventionsNot applicable, all subjects will receive usual rehabilitation care independently from each other and from the researchers according to prevailing guidelines.
- Primary outcomeBrunnstrom Fugl-Meyer Assessment (arm and leg section), ARAT score, and 10 meter walk test at week 12 and 26.
- Secondary outcome- Demographics and phenotype of patients
- Premorbid functioning
- Neurological status (National Institute of Health Stroke Scale, Motricity Index, O-letter Cancellation Test, Montreal Cognitive Assessment, Erasmus MC Modification of the (revised) Nottingham Sensory Assessment, Standardized Swallowing Assessment, Aphasia Bedside Check, Frenchay Arm Test, Trunk Control Test, Timed Balance Test)
- Activities and participation (Barthel Index, Functional Ambulatory Categories, modified Rankin Scale, Berg Balance Scale, number of falls)
- Self-reported (Nottingham Extended Activities of Daily Living, Motor Activity Log, Stroke Impact Scale, Fatigue Severity Scale, Hospital Anxiety and Depression Scale)
- Physical behaviour (accelerometry-based ambulatory monitoring)
- EEG
- TimepointsClinical assessments are repeated at week 1, 3, 5, 8, 12, and 26. The accelerometry-based ambulatory monitoring measurements are performed in week 3, 12, and 26. The EEG measurements are performed in week 1, 5, 8, and 12.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Slaman
- CONTACT for SCIENTIFIC QUERIESDr. C.G.M. Meskers
- Sponsor/Initiator Erasmus Medical Center, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryFunctional recovery at 6 months post stroke appears to be largely defined within the first 72 hours after stroke onset. In addition, most of the time dependent dynamic changes in recovery plateau within 8-12 weeks after stroke onset. The majority of patients show a fixed proportional change of about 70% of their initial baseline level. However, 30% of patients with an initial poor prognosis are identified improperly. Therefore, prediction models of functional outcome post stroke need further improvement. Moreover, prediction rules need to be verified in those patients that were excluded from above-mentioned longitudinal studies due to co-morbidity, repetitive strokes and/or hemorrhagic strokes. These prediction rules should be able to handle the large variety in stroke patients that is currently encountered in our stroke units. Answering aforementioned questions requires uniform, repeated and time-fixed assessment of determinants and measures of functional outcome after stroke. Additional neurophysiological assessment may be needed to improve prognostic models.
- Main changes (audit trail)
- RECORD30-mrt-2017 - 16-jul-2017


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