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; Gary A. Ford; Jennifer Hislop; Steven Hogg; Denise Howel; Niall Hughes; Hermano Igo Krebs; Christopher Price; Lynn Rochester; Elaine Stamp; Laura Ternent; Duncan Turner; Luke Vale; Elizabeth Warburton; Frederike van Wijck; Scott Wilkes

doi:10.1186/s13063-017-2083-4

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, Gary A. Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs, Christopher Price, Lynn Rochester, Elaine Stamp, Laura TernentDuncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes

^*Corresponding author for this work

Glasgow Caledonian University

Research output: Contribution to journal › Article › peer-review

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Abstract

Background

Loss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke.

Methods/design

Study design: a pragmatic, three-arm, multicentre randomisedcontrolled trial, economic analysis and process evaluation.

Setting: NHS stroke services.

Participants: adults with acute or chronic first-ever stroke(1 week to 5 years post stroke) causing moderate to severe upper limbfunctional limitation.

Randomisation groups:

1. Robot-assisted training using the InMotion robotic gymsystem for 45 min, three times/week for 12 weeks

2. Enhanced upper limb therapy for 45 min, threetimes/week for 12 weeks

3. Usual NHS care in accordance with local clinical practice

Randomisation: individual participant randomisationstratified by centre, time since stroke, and severity of upper limb impairment.

Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months.

Blinding: outcomes are undertaken by blinded assessors.

Economic analysis: micro-costing and economic evaluation ofinterventions compared to usual NHS care. A within-trial analysis, with aneconomic model will be used to extrapolate longer-term costs and outcomes.

Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial.

Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points.

Discussion

The results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.

Trial registration

ISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.

Original language	English
Article number	340 (2017)
Number of pages	16
Journal	Trials
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s13063-017-2083-4
Publication status	Published - 20 Jul 2017

Keywords

stroke, arm, rehabilitation, robotics, RCT, cost-effectiveness analysis, parallel process evaluation

Documents and Links

10.1186/s13063-017-2083-4

Rodgers, et al (2017) Robot assisted training for the upper limb after stroke (RATULS) study protocol for a randomised controlled trial
© The Author(s). 2017 Crown copyright; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
Final published version, 616 KBLicence: CC BY

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Rodgers, H., Shaw, L., Bosomworth, H., Aird, L., Alvarado, N., Andole, S., Cohen, D. L., Dawson, J., Eyre, J., Finch, T., Ford, G. A., Hislop, J., Hogg, S., Howel, D., Hughes, N., Krebs, H. I., Price, C., Rochester, L., Stamp, E., ... Wilkes, S. (2017). Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial. Trials, 18(1), [340 (2017)]. https://doi.org/10.1186/s13063-017-2083-4

Rodgers, Helen ; Shaw, Lisa ; Bosomworth, Helen ; Aird, Lydia ; Alvarado, Natasha ; Andole, Sreeman ; Cohen, David L. ; Dawson, Jesse ; Eyre, Janet ; Finch, Tracy ; Ford, Gary A. ; Hislop, Jennifer ; Hogg, Steven ; Howel, Denise ; Hughes, Niall ; Krebs, Hermano Igo ; Price, Christopher ; Rochester, Lynn ; Stamp, Elaine ; Ternent, Laura ; Turner, Duncan ; Vale, Luke ; Warburton, Elizabeth ; van Wijck, Frederike ; Wilkes, Scott. / Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial. In: Trials. 2017 ; Vol. 18, No. 1.

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abstract = "BackgroundLoss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke.Methods/designStudy design: a pragmatic, three-arm, multicentre randomisedcontrolled trial, economic analysis and process evaluation.Setting: NHS stroke services.Participants: adults with acute or chronic first-ever stroke(1 week to 5 years post stroke) causing moderate to severe upper limbfunctional limitation.Randomisation groups:1. Robot-assisted training using the InMotion robotic gymsystem for 45 min, three times/week for 12 weeks2. Enhanced upper limb therapy for 45 min, threetimes/week for 12 weeks3. Usual NHS care in accordance with local clinical practiceRandomisation: individual participant randomisationstratified by centre, time since stroke, and severity of upper limb impairment.Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months.Blinding: outcomes are undertaken by blinded assessors.Economic analysis: micro-costing and economic evaluation ofinterventions compared to usual NHS care. A within-trial analysis, with aneconomic model will be used to extrapolate longer-term costs and outcomes.Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial.Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points.DiscussionThe results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.Trial registrationISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.",

keywords = "stroke, arm, rehabilitation, robotics, RCT, cost-effectiveness analysis, parallel process evaluation",

author = "Helen Rodgers and Lisa Shaw and Helen Bosomworth and Lydia Aird and Natasha Alvarado and Sreeman Andole and Cohen, {David L.} and Jesse Dawson and Janet Eyre and Tracy Finch and Ford, {Gary A.} and Jennifer Hislop and Steven Hogg and Denise Howel and Niall Hughes and Krebs, {Hermano Igo} and Christopher Price and Lynn Rochester and Elaine Stamp and Laura Ternent and Duncan Turner and Luke Vale and Elizabeth Warburton and {van Wijck}, Frederike and Scott Wilkes",

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year = "2017",

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day = "20",

doi = "10.1186/s13063-017-2083-4",

language = "English",

volume = "18",

journal = "Trials",

issn = "1745-6215",

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number = "1",

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Rodgers, H, Shaw, L, Bosomworth, H, Aird, L, Alvarado, N, Andole, S, Cohen, DL, Dawson, J, Eyre, J, Finch, T, Ford, GA, Hislop, J, Hogg, S, Howel, D, Hughes, N, Krebs, HI, Price, C, Rochester, L, Stamp, E, Ternent, L, Turner, D, Vale, L, Warburton, E, van Wijck, F & Wilkes, S 2017, 'Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial', Trials, vol. 18, no. 1, 340 (2017). https://doi.org/10.1186/s13063-017-2083-4

Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial. / Rodgers, Helen; Shaw, Lisa; Bosomworth, Helen; Aird, Lydia; Alvarado, Natasha; Andole, Sreeman; Cohen, David L.; Dawson, Jesse; Eyre, Janet; Finch, Tracy; Ford, Gary A.; Hislop, Jennifer; Hogg, Steven; Howel, Denise; Hughes, Niall; Krebs, Hermano Igo; Price, Christopher; Rochester, Lynn; Stamp, Elaine; Ternent, Laura; Turner, Duncan; Vale, Luke; Warburton, Elizabeth; van Wijck, Frederike; Wilkes, Scott.

In: Trials, Vol. 18, No. 1, 340 (2017), 20.07.2017.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial

AU - Rodgers, Helen

AU - Shaw, Lisa

AU - Bosomworth, Helen

AU - Aird, Lydia

AU - Alvarado, Natasha

AU - Andole, Sreeman

AU - Cohen, David L.

AU - Dawson, Jesse

AU - Eyre, Janet

AU - Finch, Tracy

AU - Ford, Gary A.

AU - Hislop, Jennifer

AU - Hogg, Steven

AU - Howel, Denise

AU - Hughes, Niall

AU - Krebs, Hermano Igo

AU - Price, Christopher

AU - Rochester, Lynn

AU - Stamp, Elaine

AU - Ternent, Laura

AU - Turner, Duncan

AU - Vale, Luke

AU - Warburton, Elizabeth

AU - van Wijck, Frederike

AU - Wilkes, Scott

N1 - Acceptance from webpage OA journal

PY - 2017/7/20

Y1 - 2017/7/20

N2 - BackgroundLoss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke.Methods/designStudy design: a pragmatic, three-arm, multicentre randomisedcontrolled trial, economic analysis and process evaluation.Setting: NHS stroke services.Participants: adults with acute or chronic first-ever stroke(1 week to 5 years post stroke) causing moderate to severe upper limbfunctional limitation.Randomisation groups:1. Robot-assisted training using the InMotion robotic gymsystem for 45 min, three times/week for 12 weeks2. Enhanced upper limb therapy for 45 min, threetimes/week for 12 weeks3. Usual NHS care in accordance with local clinical practiceRandomisation: individual participant randomisationstratified by centre, time since stroke, and severity of upper limb impairment.Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months.Blinding: outcomes are undertaken by blinded assessors.Economic analysis: micro-costing and economic evaluation ofinterventions compared to usual NHS care. A within-trial analysis, with aneconomic model will be used to extrapolate longer-term costs and outcomes.Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial.Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points.DiscussionThe results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.Trial registrationISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.

AB - BackgroundLoss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke.Methods/designStudy design: a pragmatic, three-arm, multicentre randomisedcontrolled trial, economic analysis and process evaluation.Setting: NHS stroke services.Participants: adults with acute or chronic first-ever stroke(1 week to 5 years post stroke) causing moderate to severe upper limbfunctional limitation.Randomisation groups:1. Robot-assisted training using the InMotion robotic gymsystem for 45 min, three times/week for 12 weeks2. Enhanced upper limb therapy for 45 min, threetimes/week for 12 weeks3. Usual NHS care in accordance with local clinical practiceRandomisation: individual participant randomisationstratified by centre, time since stroke, and severity of upper limb impairment.Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months.Blinding: outcomes are undertaken by blinded assessors.Economic analysis: micro-costing and economic evaluation ofinterventions compared to usual NHS care. A within-trial analysis, with aneconomic model will be used to extrapolate longer-term costs and outcomes.Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial.Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points.DiscussionThe results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.Trial registrationISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.

KW - stroke, arm, rehabilitation, robotics, RCT, cost-effectiveness analysis, parallel process evaluation

U2 - 10.1186/s13063-017-2083-4

DO - 10.1186/s13063-017-2083-4

M3 - Article

C2 - 28728602

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 340 (2017)

ER -