ULTRA-stroke.

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 patients’ 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.

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.

30-03-2009: start inclusion of patients.

28-02-2012: end of inclusion of patients.

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.