Evidence map›Paper›PMID 28728602›Full record

Trial reportTrials2017

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial.

Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L Cohen, Jesse Dawson, Janet Eyre, Tracy Finch and 15 more

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
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. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

25 authors.

Helen RodgersStroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK. helen.rodgers@newcastle.ac.uk.
Lisa ShawStroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Helen BosomworthStroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Lydia AirdStroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.
Natasha AlvaradoInstitute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Sreeman AndoleBarking, Havering and Redbridge University Hospitals NHS Trust Queen's Hospital, Rom Valley Way, Romford, Essex, RM7 0AG, UK.
David L CohenNorth West London Hospitals NHS Trust, Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ, UK.
Jesse DawsonUniversity of Glasgow, Queen Elizabeth University Hospital, 1342 Govan Road, Govan, Glasgow, G51 4TF, UK.
Janet EyreDepartment of Child Health, Institute of Neuroscience, Newcastle University, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
Tracy FinchInstitute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Gary A FordMedical Sciences Division, University of Oxford, and Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
Jennifer HislopHealth Economics Group, Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Steven HoggContact via: Stroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Denise HowelInstitute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Niall HughesNHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital, 1342 Govan Road, Govan, Glasgow, G51 4TF, UK.
Hermano Igo KrebsMassachusetts Institute of Technology, 77 Massachusetts Avenue, 3-137, Cambridge, MA, 02139, USA.
Christopher PriceStroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Lynn RochesterInstitute of Neuroscience, Newcastle University, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL, UK.
Elaine StampInstitute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Laura TernentHealth Economics Group, Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Duncan TurnerUniversity of East London, School of Health, Sport and Biosciences, Stratford Campus, Water Lane, Stratford, London, E15 4LZ, UK.
Luke ValeHealth Economics Group, Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Elizabeth WarburtonCambridge University Health Partners (Addenbrooke's Hospital), R3 Neurosciences, Addenbrooke's Hospital, Hills Road, Box 83, Cambridge, CB2 2QQ, UK.
Frederike van WijckInstitute for Applied Health Research and School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK.
Scott WilkesDepartment of Pharmacy, Health and Wellbeing, Faculty of Applied Sciences, Science Complex, University of Sunderland, City Campus, Chester Road, Sunderland, SR1 3SD, UK.

Funding

Department of Health 11/26/05
6 · The paper itself

Abstract

backgroundLoss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. METHODS/

designStudy design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation.

settingNHS stroke services.

participantsadults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. PRIMARY OUTCOME: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. SECONDARY OUTCOMES: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. SAMPLE SIZE: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points. DISCUSSION: The results from this trial will determine whether robot-assisted training improves upper limb function post stroke.

trial registrationISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013.

Indexed as

Exercise TherapyRoboticsBiomechanical PhenomenaClinical ProtocolsCost-Benefit AnalysisDisability EvaluationHealth Care CostsHumansModels, EconomicQuality-Adjusted Life YearsQuality of LifeRecovery of FunctionResearch DesignState MedicineStrokeStroke RehabilitationArmCost-effectiveness analysisParallel process evaluationRCTRehabilitationRoboticsStroke

Identifiers

PMID28728602
PMCPMC5520386

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.