|- candidate number||5282|
|- NTR Number||NTR1665|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-feb-2009|
|- Secondary IDs||NL 20456.029.08 METc VUmc |
|- Public Title||ULTRA-stroke.|
|- Scientific Title||Upper limb training after stroke: Contrasting the clinical effects and underlying mechanisms of unilateral and bilateral training.|
|- hypothesis||1. Both Constrained Induced Movement Therapy (CIMT) and Bilateral Arm Training with Auditory Cueing (BATRAC) are expected to significantly improve upper limb function when compared to a Dose- Matched Control Therapy (DMCT). CIMT is expected to have a larger impact on those subjects who already showed some dexterity at recruitment, given the importance of CST integrity for motor control of the distal part of the upper limb. BATRAC, on the other hand, is expected to be also effective for subjects that were more restricted in this regard, thanks to influences stemming from and reorganizations in the contralesional hemisphere. The effects of BATRAC and CIMT are both expected to sustain over a retention period;|
2. Observed therapy-induced changes in upper limb function can be related to changes in (sub)cortical reorganisation, peripheral neuromechanics and sources of interlimb interactions.
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- Inclusion criteria||1. First-ever ischemic or hemorrhagic stroke in one of the hemispheres within the previous 6 months;|
2. Upper limb deficit;
3. 18 to 80 years of age;
4. Motivated to participate;
5. Give written or oral informed consent.
|- Exclusion criteria||1. Suffer from upper extremity orthopaedic limitations that may affect the results;|
2. Not being able to communicate;
3. Disoriented with regard to time and place;
4. Pacemaker or other metallic implants.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-mrt-2009|
|- planned closingdate||31-mei-2012|
|- Target number of participants||60|
|- Interventions||1. Constrained Induced Movement Therapy (CIMT); 3 times a week 1 hour, for 6 consecutive weeks;|
2. Bilateral Arm Training with Auditory Cueing (BATRAC); 3 times a week 1 hour, for 6 consecutive weeks;
3. Dose-Matched Control Therapy (DMCT); 3 times a week 1 hour, for 6 consecutive weeks.
|- Primary outcome||1. Action Research Arm test (ARAT);|
2. Patterns of correlated cortical activity in original and contralateral target areas and changes in spectral power in specific frequency bands;
3. Neuromechanics, i.e. stiffness, motor function (paresis) and control (reflex gains and modulation) around wrist joint;
4. Contribution of sources (feedforward, error correction, and fase entrainment) of interlimb interactions.
|- Secondary outcome||1. Motricity Index;|
2. Nine Hole Peg test;
3. Brunnstrom Fugl Meyer arm-hand test;
4. Nine hole peg test;
5. Erasmus MC modification of Nottingham sensory assessment;
6. Stroke impact scale 3.0;
7. Motor activity log.
|- Timepoints||30-03-2009: start inclusion of patients.|
28-02-2012: end of inclusion of patients.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Mphil L. Delden, van |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. G. Kwakkel|
|- Sponsor/Initiator ||VU University Medical Center, Department of Rehabilitation Medicine, VU Faculty of Human Movement Sciences, MOVE, Rehabilitation Centre Amsterdam|
(Source(s) of Monetary or Material Support)
|MOVE Research Institute|
|- Brief summary||Prospective cohort studies show that about 80% of all stroke survivors have an upper limb paresis immediately after stroke. Unfortunately, 60 to 70% of stroke survivors will continue to experience upper extremity functional limitations, which is associated with diminished health related quality of life after stroke. Recent studies have indicated that stroke patientsí upper limb function may be improved using specific therapeutic protocols with a strong conceptual motivation. Therefore, powerful randomised clinical trials (RCTs) investigating the effectiveness and testing the conceptual motivation of innovative therapies are urgently needed in stroke rehabilitation. In addition, a better understanding is needed of mechanisms associated with treatment-induced effects in order to improve future treatment strategies.
Here, we propose such an RCT that is both clinically and theoretically relevant. The RCT is aimed at investigating the effects of Bilateral Arm Training with Rhythmic Auditory Cueing (BATRAC) and Constrained Induced Movement Therapy (CIMT) in subacute stroke patients with an upper limb deficit. Both interventions will be compared to a Dose-Matched Control Treatment (DMCT) based on usual practice. Apart from an assessment of the intervention-induced changes in upper limb functionality (i.e., primary outcome measure Action Research Arm Test (ARAT)), this BATRAC-CIMT study explicitly aims at uncovering the mechanisms that are associated with regaining dexterity. For this latter purpose, included patients will be stratified with respect to the severity of upper limb paresis (reflecting the intactness of the primary motor system). Moreover, specific predictions regarding intervention-induced changes will be examined with respect to 1) peripheral stiffness of the upper paretic limb (using a haptic robotic), 2) interlimb interactions governing bimanual coordination (based on kinematics), and 3) cortical activation patterns of ipsi- and contralateral hemisphere as well as cerebellum (using MEG). Thus, besides an evaluation of the relative effectiveness of the treatments of interest, this RCT will shed light on whether exercise-induced improvements in upper limb coordination and dexterity are associated with either ipsi- or contralesional adaptations in the affected and non-affected hemisphere or contralesional cerebellum.
|- Main changes (audit trail)|
|- RECORD||6-feb-2009 - 14-sep-2009|