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Open Access Highly Accessed Study protocol

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

A (Lex) EQ van Delden1*, C (Lieke) E Peper1, Jaap Harlaar2, Andreas Daffertshofer1, Nienke I Zijp3, Kirsten Nienhuys3, Peter Koppe3, Gert Kwakkel2 and Peter J Beek1

Author Affiliations

1 Research Institute MOVE, Faculty of Human Movement Sciences, VU University Amsterdam, Van der Boechorststraat 9, 1081 BT Amsterdam, The Netherlands

2 Research Institute MOVE, Department of Rehabilitation Medicine, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands

3 Rehabilitation Centre Amsterdam, Overtoom 283, 1054 HW Amsterdam, The Netherlands

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BMC Neurology 2009, 9:57  doi:10.1186/1471-2377-9-57

Published: 6 November 2009

Abstract

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 webcite, number NTR1665).