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EXPLICIT-stroke


- candidate number3880
- NTR NumberNTR1424
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-aug-2008
- Secondary IDsZON MW reg nr.  89000001
- Public TitleEXPLICIT-stroke
- Scientific TitleExplaining plasticity after stroke, a multicenter research program consisting of a randomized clinical trial on the effect of early intervention in stroke rehabilitation and a longitudinal survey into the dynamics of post-stroke recovery.
- ACRONYMEXPLICIT-stroke
- hypothesis1. Early rehabilitation intervention, i.e. Constraint Induced Movement Therapy (CIMT) or Elektromyography triggered neuromuscular stimulation (EMG-NMS), has a positive effect on functional outcome of upper limb paresis post stroke (A project)
2. Observed therapy-induced changes in upper limb function can be related to changes in (sub)cortical reorganisation, corticospinal tract integrity, peripheral neuromechanics and compensation strategies (B project).
- Healt Condition(s) or Problem(s) studiedStroke, Stroke
- Inclusion criteria1. First ever ischemic lesion in territory of MCA
2. Mono- or hemiparesis (NIHSS item 5a&b score 1-4)
3. Age 18-80
4. Able to comprehend and communicate
5. Able to sit for 30 s without support
6. Motivated to participate in an intensive rehabilitation treatment programme for 3 weeks
7. Written or oral informed consent
- Exclusion criteria1. Trombolysis (rTPA, alteplase) with positive effect
2. Pacemaker or metallic implants
3. Orthopaedic limitations of upper extremity
4. Not being able to communicate
5. Botuline toxine or medication that may influence upper limb function in previous 3 months.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2008
- planned closingdate31-dec-2013
- Target number of participants180
- Interventionsgroup A1: good prognosis: Constraint Induced Movement Therapy (CIMT) for 3 consecutive weeks, 5 days a week versus conventional therapy
group A2: poor prognosis:
Elektromyography-triggered neuromuscular stimulation (EMG-NMS) for 3 consecutive weeks, 5 days a week versus conventional therapy
- Primary outcome- ARAT (A projects)
- Focussing of cortical activity in original target area (fMRI, B1 project)
- Integrity of corticospinal tract (TMS)
- Trunk movement in standard reaching task (B2 project)
- Neuromechanics, i.e. stiffness, motor function (paresis) and control (reflex gains and modulation) around wrist joint (B3 project)
- Secondary outcome- Modified Ashworth score
- Wolf motor function test
- Frenchay arm test
- Motoricity index
- Brunnstrom Fugl Meyer arm-hand test
- Nine hole peg test
- Erasmus MC modification of Nottingham sensory assessment
- Stroke impact scale 3.0
- Nottingham extended ADL
- Motor activity log
- O-letter cancelation test
- Barthel index
- Timepoints15-09-2008: start inclusion of patients
31-12-2012: end of inclusion of patients
- Trial web sitehttp://www.explicit-stroke.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.H. Arendzen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. G. Kwakkel
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Rehabilitation Medicine, VU University Medical Center, Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryProspective cohort studies show that about 80% of all stroke survivors have an upper limb paresis immediately after stroke. Only one third of all stroke patients will regain some dexterity, whereas well-researched evidence based therapies for effective treatment of the upper limb are lacking. However, the main claim of the literature is that functional recovery of the upper paretic limb is mainly defined within the first month post-stroke and that rehabilitation services should be applied preferably within this time window. Furthermore, it is known that exercise-related interventions are most effective when they are applied intensively and in a task-oriented way. EXPLICIT-stroke aims to obtain better functional outcome by early intensive rehabilitation. Next to clinical tests to measure improvement in function, neuroplasticity is assessed by fMRI, TMS, kinematics and haptic robots. The combination of clinical outcome measures and neuro-imaging will serve as a template for understanding basic mechanisms of functional recovery after stroke. EXPLICIT-stroke will provide an answer to the key question whether therapy induced improvements are due to either a reduction of basic motor impairment by neural repair or the use of behavioral compensation strategies.
- Main changes (audit trail)
- RECORD27-aug-2008 - 8-sep-2008


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