Evidence map›Paper›PMID 35468766›Full record

Trial reportBMC neurology2022

Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial.

Natasha A Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Steven Faux, Mithu Palit, Senen Gonzalez, John Olver, Emma Schneider, Maria Crotty and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 4 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
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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

11 authors.

Natasha A LanninDepartment of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia. natasha.lannin@monash.edu.
Louise AdaThe University of Sydney, Sydney, Australia.
Coralie EnglishSchool of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, Australia.
Julie RatcliffeCollege of Nursing and Health Sciences, Flinders University, Adelaide, Australia.
Steven FauxSacred Heart Rehabilitation Unit, St Vincent's Hospital, Sydney, Australia.
Mithu PalitAlfred Health, Melbourne, Australia.
Senen GonzalezAustin Health, Melbourne, Australia.
John OlverEpworth Monash Rehabilitation Medicine Research Unit, Monash University, Melbourne, Australia.
Emma SchneiderDepartment of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia.
Maria CrottyCollege of Nursing and Health Sciences, Flinders University, Adelaide, Australia.
Ian D CameronJohn Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, Sydney, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies.

aimTo determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke.

methodAn analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life.

resultsBy 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome.

conclusionAdditional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term.

trial registrationACTRN12615000616572 (12/06/2015).

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsStrokeStroke RehabilitationBrain Damage, ChronicHumansMuscle SpasticityQuality of LifeTreatment OutcomeUpper ExtremityBotulinum Toxins, Type ANeuromuscular AgentsBotulinum toxin type ANeuroscienceRehabilitationSpasticityStrokeWrist

Identifiers

PMID35468766
PMCPMC9036685

What OpenQuestion holds

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Registered trials

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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.