FAST INdiCATE trial protocol: clinical efficacy of functional strength training for upper limb motor recovery early after stroke: neural correlates and prognostic indicators

Pomeroy, V. M. et al. (2014) FAST INdiCATE trial protocol: clinical efficacy of functional strength training for upper limb motor recovery early after stroke: neural correlates and prognostic indicators. International Journal of Stroke, 9(2), pp. 240-245. (doi: 10.1111/ijs.12179)

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Publisher's URL: http://dx.doi.org/10.1111/ijs.12179

Abstract

<b>Rationale</b><p></p> Functional strength training in addition to conventional physical therapy could enhance upper limb recovery early after stroke more than movement performance therapy plus conventional physical therapy.<p></p> <b>Aims</b><p></p> To determine (a) the relative clinical efficacy of conventional physical therapy combined with functional strength training and conventional physical therapy combined with movement performance therapy for upper limb recovery; (b) the neural correlates of response to conventional physical therapy combined with functional strength training and conventional physical therapy combined with movement performance therapy; (c) whether any one or combination of baseline measures predict motor improvement in response to conventional physical therapy combined with functional strength training or conventional physical therapy combined with movement performance therapy.<p></p> <b>Design</b><p></p> Randomized, controlled, observer-blind trial.<p></p> <b>Study</b><p></p> The sample will consist of 288 participants with upper limb paresis resulting from a stroke that occurred within the previous 60 days. All will be allocated to conventional physical therapy combined with functional strength training or conventional physical therapy combined with movement performance therapy. Functional strength training and movement performance therapy will be undertaken for up to 1·5 h/day, five-days/week for six-weeks.<p></p> <b>Outcomes and Analysis</b><p></p> Measurements will be undertaken before randomization, six-weeks thereafter, and six-months after stroke. Primary efficacy outcome will be the Action Research Arm Test. Explanatory measurements will include voxel-wise estimates of brain activity during hand movement, brain white matter integrity (fractional anisotropy), and brain–muscle connectivity (e.g. latency of motor evoked potentials). The primary clinical efficacy analysis will compare treatment groups using a multilevel normal linear model adjusting for stratification variables and for which therapist administered the treatment. Effect of conventional physical therapy combined with functional strength training versus conventional physical therapy combined with movement performance therapy will be summarized using the adjusted mean difference and 95% confidence interval. To identify the neural correlates of improvement in both groups, we will investigate associations between change from baseline in clinical outcomes and each explanatory measure. To identify baseline measurements that independently predict motor improvement, we will develop a multiple regression model.<p></p>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McConnachie, Professor Alex
Authors: Pomeroy, V. M., Ward, N. S., Johansen-Berg, H., van Vliet, P., Burridge, J., Hunter, S. M., Lemon, R. N., Rothwell, J., Weir, C. J., Wing, A., Walker, A. A., Kennedy, N., Barton, G., Greenwood, R. J., and McConnachie, A.
Subjects:R Medicine > R Medicine (General)
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
Journal Name:International Journal of Stroke
Publisher:Wiley-Blackwell Publishing Ltd.
ISSN:1747-4930
ISSN (Online):1747-4949
Copyright Holders:Copyright © 2013 The Authors
First Published:First published in International Journal of Stroke 9(2):240-245
Publisher Policy:Reproduced under a Creative Commons License

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