Evidence map›Paper›PMID 31128926›Full record

Trial reportLancet (London, England)2019

Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial.

Helen Rodgers, Helen Bosomworth, Hermano I Krebs, Frederike van Wijck, Denise Howel, Nina Wilson, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L Cohen and 13 more

Registry-linked trialAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04164381 (Use of Robotics to Improve Cognitive Functions in Subject With Subacute Stroke), which is not on this map. Cited by 203 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
203citing papers in PubMed, 20 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.

NCT04164381 nacompletednot on this map

Use of Robotics to Improve Cognitive Functions in Subject With Subacute Stroke: a Bicentric Pilot Study

TypeinterventionalSponsorFondazione Don Carlo Gnocchi ETSRan2019 to 2020Enrolled51ConditionsStrokeArmsRobotic assisted intervention
3 · Its place in the literature

Who cites it

203 citing papers in PubMed, 20 syntheses or guidelines pooled it.

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143 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Helen RodgersStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK; Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK; Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. Electronic address: helen.rodgers@newcastle.ac.uk.
Helen BosomworthStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
Hermano I KrebsMassachusetts Institute of Technology, Cambridge, MA, USA.
Frederike van WijckSchool of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Denise HowelInstitute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Nina WilsonInstitute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Lydia AirdStroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK.
Natasha AlvaradoSchool of Healthcare, University of Leeds, Leeds, UK.
Sreeman AndoleBarking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.
David L CohenLondon North West Healthcare NHS Trust, Northwick Park Hospital, Harrow, UK.
Jesse DawsonInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Cristina Fernandez-GarciaInstitute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Tracy FinchNursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.
Gary A FordStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK; Medical Sciences Division, University of Oxford and Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Richard FrancisStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
Steven HoggStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
Niall HughesNHS Greater Glasgow and Clyde, Glasgow, UK.
Christopher I PriceStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK; Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK.
Laura TernentInstitute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Duncan L TurnerSchool of Health, Sport and Bioscience, University of East London, London, UK.
Luke ValeInstitute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Scott WilkesSchool of Medicine, University of Sunderland, Sunderland, UK.
Lisa ShawStroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.

Funding

Medical Research Council MR/K02325X/1
6 · The paper itself

Abstract

backgroundLoss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care.

methodsRATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850.

findingsBetween April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention.

interpretationRobot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice.

fundingNational Institute for Health Research Health Technology Assessment Programme.

Indexed as

AgedFemaleHumansMaleMiddle AgedRecovery of FunctionRoboticsStroke RehabilitationTreatment OutcomeUnited KingdomUpper Extremity

Identifiers

PMID31128926
PMCPMC6620612

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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.