The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy: Study protocol for a randomized controlled trialReportar como inadecuado




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Trials

, 18:58

First Online: 06 February 2017Received: 29 June 2016Accepted: 28 December 2016DOI: 10.1186-s13063-016-1772-8

Cite this article as: Brændvik, S.M., Roeleveld, K., Andersen, G.L. et al. Trials 2017 18: 58. doi:10.1186-s13063-016-1772-8

Abstract

BackgroundIntramuscular injections of botulinum toxin A BoNT-A have been a cornerstone in the treatment of spasticity for the last 20 years. In Norway, the treatment is now offered to two out of three children with spastic cerebral palsy CP. However, despite its common use, the evidence for its functional effects is limited and inconclusive. The objective of this study is to determine whether BoNT-A makes walking easier in children with CP. We hypothesize that injections with BoNT-A in the calf muscles will reduce energy cost during walking, improve walking capacity, increase habitual physical activity, reduce pain and improve self-perceived performance and satisfaction.

Methods-designThis randomized, double-blinded, placebo-controlled, multicenter trial is conducted in a clinical setting involving three health regions in Norway. Ninety-six children with spastic CP, referred for single-level injections with BoNT-A in the calf muscles, will be invited to participate. Those who are enrolled will be randomized to receive either injections with BoNT-A Botox® or 0.9% saline in the calf muscles. Stratification according to age and study center will be made. The allocation ratio will be 1:1. Main inclusion criteria are 1 age 4 − 17.5 years, 2 Gross Motor Function Classification System levels I and II, 3 no BoNT-A injections in the lower limbs during the past 6 months and 4 no orthopedic surgery to the lower limbs during the past 2 years. The outcome measures will be made at baseline and 4, 12 primary endpoint and 24 weeks after injections. Primary outcome is change in energy cost during walking. Secondary outcomes are change in walking capacity, change in activity, perceived change in performance and satisfaction in mobility tasks, and pain. The primary analysis will use a linear mixed model to test for difference in change in the outcome measures between the groups. The study is approved by the Regional Ethical Committee and The Norwegian Medicines Agency. Recruitment started in September 2015.

DiscussionThe evaluation of effect is comprehensive and includes objective standardized tests and measures on both impairment and activity level. Results are to be expected by spring 2019.

Trial registrationClinicalTrials.gov, NCT02546999. Registered on 9 September 2015.

KeywordsCerebral palsy Spasticity Botulinum toxin A Walking Energy cost Activity Pain Abbreviations1MWT1-Minute Walk Test

5MWT5-Minutes Walk Test

AEAdverse event

BoNT-ABotulinum toxin A Botox®

CPCerebral palsy

ECEnergy cost

eCRFWeb-based Case Report Form

GMFCSGross Motor Function Classification System

OMNI-RPEOMNI Rating of Perceived Exertion scale

TMFTrial Master File

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1772-8 contains supplementary material, which is available to authorized users.





Autor: Siri Merete Brændvik - Karin Roeleveld - Guro Lillemoen Andersen - Anne Elisabeth Ross Raftemo - Kjersti Ramstad - Jasmi

Fuente: https://link.springer.com/







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