Unilateral versus bilateral upper limb training after stroke: the Upper Limb Training After Stroke clinical trial.

BACKGROUND AND PURPOSE: Unilateral and bilateral training protocols for upper limb rehabilitation after stroke represent conceptually contrasting approaches with the same ultimate goal. In a randomized controlled trial, we compared the merits of modified constraint-induced movement therapy, modified bilateral arm training with rhythmic auditory cueing, and a dose-matched conventional treatment. Modified constraint-induced movement therapy and modified bilateral arm training with rhythmic auditory cueing targeted wrist and finger extensors, given their importance for functional recovery. We hypothesized that modified constraint-induced movement therapy and modified bilateral arm training with rhythmic auditory cueing are superior to dose-matched conventional treatment. METHODS: Sixty patients, between 1 to 6 months after stroke, were randomized over 3 intervention groups. The primary outcome measure was the Action Research Arm test, which was conducted before, directly after, and 6 weeks after intervention. RESULTS: Although all groups demonstrated significant improvement on the Action Research Arm test after intervention, which persisted at 6 weeks follow-up, no significant differences in change scores on the Action Research Arm test were found between groups postintervention and at follow-up. CONCLUSIONS: Modified constraint-induced movement therapy and modified bilateral arm training with rhythmic auditory cueing are not superior to dose-matched conventional treatment or each other in improving upper limb motor function 1 to 6 months after stroke. CLINICAL TRIAL REGISTRATION URL: http://www.trialregister.nl. Unique identifier: NTR1665.

Comparing unilateral and bilateral upper limb training: the ULTRA-stroke program design.

BACKGROUND: About 80% of all stroke survivors have an upper limb paresis immediately after stroke, only about a third of whom (30 to 40%) regain some dexterity within six months following conventional treatment programs. Of late, however, two recently developed interventions--constraint-induced movement therapy (CIMT) and bilateral arm training with rhythmic auditory cueing (BATRAC)--have shown promising results in the treatment of upper limb paresis in chronic stroke patients. The ULTRA-stroke (acronym for Upper Limb TRaining After stroke) program was conceived to assess the effectiveness of these interventions in subacute stroke patients and to examine how the observed changes in sensori-motor functioning relate to changes in stroke recovery mechanisms associated with peripheral stiffness, interlimb interactions, and cortical inter- and intrahemispheric networks. The present paper describes the design of this single-blinded randomized clinical trial (RCT), which has recently started and will take several years to complete. METHODS/DESIGN: Sixty patients with a first ever stroke will be recruited. Patients will be stratified in terms of their remaining motor ability at the distal part of the arm (i.e., wrist and finger movements) and randomized over three intervention groups receiving modified CIMT, modified BATRAC, or an equally intensive (i.e., dose-matched) conventional treatment program for 6 weeks. Primary outcome variable is the score on the Action Research Arm test (ARAT), which will be assessed before, directly after, and 6 weeks after the intervention. During those test sessions all patients will also undergo measurements aimed at investigating the associated recovery mechanisms using haptic robots and magneto-encephalography (MEG). DISCUSSION: ULTRA-stroke is a 3-year translational research program which aims (1) to assess the relative effectiveness of the three interventions, on a group level but also as a function of patient characteristics, and (2) to delineate the functional and neurophysiological changes that are induced by those interventions.The outcome on the ARAT together with information about changes in the associated mechanisms will provide a better understanding of how specific therapies influence neurobiological changes, and which post-stroke conditions lend themselves to specific treatments. TRIAL REGISTRATION: The ULTRA-stroke program is registered at the Netherlands Trial Register (NTR, http://www.trialregister.nl, number NTR1665).