dc.contributor.author | Brændvik, Siri Merete | |
dc.contributor.author | Roeleveld, Karin | |
dc.contributor.author | Andersen, Guro Lillemoen | |
dc.contributor.author | Raftemo, Anne Elisabeth Ross | |
dc.contributor.author | Ramstad, Kjersti | |
dc.contributor.author | Majkic-Tajsic, Jasmina | |
dc.contributor.author | Lamvik, Torarin | |
dc.contributor.author | Lund, Bendik | |
dc.contributor.author | Follestad, Turid | |
dc.contributor.author | Vik, Torstein | |
dc.date.accessioned | 2017-05-29T08:31:16Z | |
dc.date.available | 2017-05-29T08:31:16Z | |
dc.date.created | 2017-02-15T13:30:26Z | |
dc.date.issued | 2017 | |
dc.identifier.citation | Trials. 2017, 18 (1), . | nb_NO |
dc.identifier.issn | 1745-6215 | |
dc.identifier.uri | http://hdl.handle.net/11250/2443650 | |
dc.description.abstract | Background
Intramuscular 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/design
This 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.
Discussion
The 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. | nb_NO |
dc.language.iso | eng | nb_NO |
dc.publisher | BioMed Central | nb_NO |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial | nb_NO |
dc.type | Journal article | nb_NO |
dc.type | Peer reviewed | nb_NO |
dc.source.pagenumber | 8 | nb_NO |
dc.source.volume | 18 | nb_NO |
dc.source.journal | Trials | nb_NO |
dc.source.issue | 1 | nb_NO |
dc.identifier.doi | 10.1186/s13063-016-1772-8 | |
dc.identifier.cristin | 1450829 | |
dc.description.localcode | © The Author(s). 2017. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. | nb_NO |
cristin.unitcode | 194,65,30,0 | |
cristin.unitcode | 194,65,10,0 | |
cristin.unitcode | 194,63,15,0 | |
cristin.unitname | Institutt for nevromedisin | |
cristin.unitname | Institutt for laboratoriemedisin, barne- og kvinnesykdommer | |
cristin.unitname | Institutt for matematiske fag | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |