Evidence map›Paper›PMID 26286662›Full record

Trial reportBMC neurology2015

Effects of botulinum toxin A and/or bimanual task-oriented therapy on upper extremity activities in unilateral Cerebral Palsy: a clinical trial.

Lucianne Speth, Yvonne Janssen-Potten, Eugene Rameckers, Anke Defesche, Bjorn Winkens, Jules Becher, Rob Smeets, Hans Vles

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03410667 (A Patient-centered Approach to Urinary Incontinence and Quality of Life in Children and Adolescents With Spina Bifida), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03410667 naactive not recruitingnot on this mapstarted 2019, after this paper: background citation

A Patient-centered Approach to Urinary Incontinence and Quality of Life in Children and Adolescents With Spina Bifida

TypeinterventionalSponsorIndiana UniversityRan2019 to 2026Enrolled67ConditionsSpina Bifida, MyelomeningoceleArmsPhase One: Exploration, Phase Two: Creation, Phase Three: Reflection, Aim 3
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Article
  8. 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

8 authors.

Lucianne SpethAdelante, Paediatric Rehabilitation, Onderstestraat 29, 6301 , KA, Valkenburg, The Netherlands. l.speth@adelante-zorggroep.nl.
Yvonne Janssen-PottenAdelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. y.janssen-potten@adelante-zorggroep.nl.
Eugene RameckersAdelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. eaa.rameckers@hetnet.nl.
Anke DefescheAdelante, Paediatric Rehabilitation, Onderstestraat 29, 6301 , KA, Valkenburg, The Netherlands. a.defesche@adelante-zorggroep.nl.
Bjorn WinkensDepartment of Methodology and Statistics, Maastricht University, Research School CAPHRI, Maastricht, The Netherlands. bjorn.winkens@maastrichtuniversity.nl.
Jules BecherDepartment of Rehabilitation Medicine, Free University Medical Centre, De Boelelaan 1118, 1081 , HZ, Amsterdam, The Netherlands. jg.becher@vumc.nl.
Rob SmeetsAdelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. rob.smeets@mumc.nl.
Hans VlesDepartment of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands. jsh.vles@mumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study reports on the effects of botulinum toxin A (BoNT-A) injections in the upper extremity (UE) in children with unilateral Cerebral Palsy (uCP) combined with bimanual task-oriented therapy (BITT) or either treatment modality performed separately. Bimanual activities were measured with the Assisting Hand Assessment (AHA), the ABILHand-Kids questionnaire (AK), the Observational Skills Assessment Score (OSAS). Goal achievement was measured with Goal Attainment Scaling (GAS), using blind video assessment, and the Canadian Occupational Performance Measure (COPM).

methodsThirty-five children, mean age 7.14 years (SD 2.63), 11 Manual Ability Classification Score (MACS) I, 15 MACS II and 9 MACS III, participated. The trial started with four study groups: BoNT-A-only (n = 5), BITT-only (n = 11), BoNT-A + BITT (n = 13), and control (n = 6). Twenty-two children were randomised, 13 children received their parents' preferred treatment: BoNT-A + BITT or BITT-only. Three comparisons were analysed: BITT (BoNT-A + BITT and BITT-only; n = 24) versus no BITT (BoNT-A-only and control; n = 11), BoNT-A (BoNT-A-only and BoNT-A + BITT; n = 18) versus no BoNT-A (BITT-only and control; n = 17), and the additional effect of BoNT-A (BoNT-A + BITT versus BITT-only). Follow-up time: 24 weeks.

resultsNo significant differences between the groups were found on the AHA. The amount of use of both hands on the OSAS was significantly better in the BoNT-A group in the beading and sandwich-making task. The BoNT-A group also showed significant improvement in the quality scores of the OSAS: the wrist position during grasping and holding, especially in the younger children. The BITT group improved significantly on the AK and significantly more on the performance and satisfaction scores of the COPM at 12 and 24 weeks regarding several goals. BoNT-A showed a significant negative effect at 12 and 24 weeks in the most important goal. BITT, more than BoNT-A + BITT, showed positive effects on the GAS score at 12 (significant), 18 and 24 weeks.

conclusionsBoNT-A has a positive effect on quality of movement and amount of use of the affected UE during the 3 months' working time. BoNT-A has no additional effect on bimanual performance and goal achievement. BITT has a positive effect on goal achievement and bimanual performance, even up to 6 weeks after therapy had stopped.

trial registrationCurrent Controlled Trials ISRCTN69541857.

Indexed as

Botulinum Toxins, Type ACerebral PalsyChildChild, PreschoolCombined Modality TherapyExercise TherapyFemaleHandHand StrengthHumansMaleMovementOccupational TherapySurveys and QuestionnairesTreatment OutcomeUpper ExtremityBotulinum Toxins, Type A

Identifiers

PMID26286662
PMCPMC4544795

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.