Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial
Background Loss 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/design Study des...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Article |
| Language: | English |
| Published: |
BioMed Central Ltd
2017
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| Online Access: | http://hdl.handle.net/1721.1/110818 |
| _version_ | 1811075048582152192 |
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| author | 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 Price, Christopher Rochester, Lynn Stamp, Elaine Ternent, Laura Turner, Duncan Vale, Luke Warburton, Elizabeth van Wijck, Frederike Wilkes, Scott Cohen, David L. Ford, Gary A. Krebs, Hermano Igo Krebs, Hermano I |
| author2 | Massachusetts Institute of Technology. Department of Mechanical Engineering |
| author_facet | Massachusetts Institute of Technology. Department of Mechanical Engineering 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 Price, Christopher Rochester, Lynn Stamp, Elaine Ternent, Laura Turner, Duncan Vale, Luke Warburton, Elizabeth van Wijck, Frederike Wilkes, Scott Cohen, David L. Ford, Gary A. Krebs, Hermano Igo Krebs, Hermano I |
| author_sort | Rodgers, Helen |
| collection | MIT |
| description | Background
Loss 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/design
Study design: a pragmatic, three-arm, multicentre randomised controlled 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 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. |
| first_indexed | 2024-09-23T09:59:49Z |
| format | Article |
| id | mit-1721.1/110818 |
| institution | Massachusetts Institute of Technology |
| language | English |
| last_indexed | 2024-09-23T09:59:49Z |
| publishDate | 2017 |
| publisher | BioMed Central Ltd |
| record_format | dspace |
| spelling | mit-1721.1/1108182022-09-30T18:11:26Z 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 Price, Christopher Rochester, Lynn Stamp, Elaine Ternent, Laura Turner, Duncan Vale, Luke Warburton, Elizabeth van Wijck, Frederike Wilkes, Scott Cohen, David L. Ford, Gary A. Krebs, Hermano Igo Krebs, Hermano I Massachusetts Institute of Technology. Department of Mechanical Engineering Krebs, Hermano I Background Loss 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/design Study design: a pragmatic, three-arm, multicentre randomised controlled 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 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. 2017-07-24T13:47:01Z 2017-07-24T13:47:01Z 2017-07 2016-10 2017-07-23T03:13:13Z Article http://purl.org/eprint/type/JournalArticle 1745-6215 http://hdl.handle.net/1721.1/110818 Rodgers, Helen; Shaw, Lisa; Bosomworth, Helen et al. "Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial." Trials 18 (July 2017): 340 © 2017 The Author(s) en http://dx.doi.org/10.1186/s13063-017-2083-4 Trials Creative Commons Attribution http://creativecommons.org/licenses/by/4.0/ The Author(s). application/pdf BioMed Central Ltd BioMed Central |
| spellingShingle | 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 Price, Christopher Rochester, Lynn Stamp, Elaine Ternent, Laura Turner, Duncan Vale, Luke Warburton, Elizabeth van Wijck, Frederike Wilkes, Scott Cohen, David L. Ford, Gary A. Krebs, Hermano Igo Krebs, Hermano I Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title | Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title_full | Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title_fullStr | Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title_full_unstemmed | Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title_short | Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial |
| title_sort | robot assisted training for the upper limb after stroke ratuls study protocol for a randomised controlled trial |
| url | http://hdl.handle.net/1721.1/110818 |
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