Evidence map›Paper›PMID 28166806›Full record

Trial reportTrials2017

The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial.

Siri Merete Brændvik, Karin Roeleveld, Guro Lillemoen Andersen, Anne Elisabeth Ross Raftemo, Kjersti Ramstad, Jasmina Majkic-Tajsic, Torarin Lamvik, Bendik Lund, Turid Follestad, Torstein Vik

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02546999 (Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02546999 phase4completednot on this map

Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

TypeinterventionalSponsorSt. Olavs HospitalRan2015 to 2021Enrolled61ConditionsCerebral Palsy, Muscle SpasticityArmsbotox, placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Siri Merete BrændvikDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology, NTNU, Trondheim, Norway. siri.merete.brandvik@ntnu.no.
Karin RoeleveldDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
Guro Lillemoen AndersenChildren's Center, Vestfold Hospital Trust, Tønsberg, Norway.
Anne Elisabeth Ross RaftemoChildren's Center, Vestfold Hospital Trust, Tønsberg, Norway.
Kjersti RamstadDepartment of Clinical Neurosciences for children, Oslo University Hospital, Oslo, Norway.
Jasmina Majkic-TajsicDivision of Child and Adolescents Health, University Hospital of North Norway, Tromsø, Norway.
Torarin LamvikDepartment of Orthopedics, St. Olav's University Hospital, Trondheim, Norway.
Bendik LundDepartment of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
Turid FollestadDepartment of Public Health and General Practice, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
Torstein VikDepartment of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
Norwegian University of Science and Technology · NOSt Olav's University Hospital · NOSykehuset i Vestfold · NOOslo University Hospital · NOUniversity Hospital of North Norway · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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.

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

Indexed as

Mobility LimitationWalkingAcetylcholine Release InhibitorsAdolescentAge FactorsBotulinum Toxins, Type ACerebral PalsyChildChild, PreschoolClinical ProtocolsDisability EvaluationDouble-Blind MethodEnergy MetabolismExercise ToleranceFemaleHumansAcetylcholine Release InhibitorsBotulinum Toxins, Type AincobotulinumtoxinAActivityBotulinum toxin ACerebral palsyEnergy costPainSpasticityWalking

Identifiers

PMID28166806
PMCPMC5294730
OpenAlexW2587597454

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.