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Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial

BACKGROUND: Early mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separ...

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Autores principales: Logan, Angela, Freeman, Jennifer, Kent, Bridie, Pooler, Jill, Creanor, Siobhan, Enki, Doyo, Vickery, Jane, Barton, Andrew, Marsden, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8892736/
https://www.ncbi.nlm.nih.gov/pubmed/35241176
http://dx.doi.org/10.1186/s40814-022-01012-4
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author Logan, Angela
Freeman, Jennifer
Kent, Bridie
Pooler, Jill
Creanor, Siobhan
Enki, Doyo
Vickery, Jane
Barton, Andrew
Marsden, Jonathan
author_facet Logan, Angela
Freeman, Jennifer
Kent, Bridie
Pooler, Jill
Creanor, Siobhan
Enki, Doyo
Vickery, Jane
Barton, Andrew
Marsden, Jonathan
author_sort Logan, Angela
collection PubMed
description BACKGROUND: Early mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separately been evaluated in the literature; however, these functionally linked tasks have not been evaluated in combination for people with severe sub-acute stroke. METHODS: The objective was to determine the feasibility of conducting a randomised controlled trial (RCT) of a functional standing frame programme compared with usual physiotherapy for people with severe sub-acute stroke. An assessor-blinded feasibility RCT with nested qualitative component (interviews and focus group) and process evaluation was adopted. Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England. Participants were randomised to receive either: (1) functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control). Both programmes were protocolised to be undertaken a minimum of five sessions per week for 3 weeks. Feasibility indicators included process, resource, management, and safety. Adherence, fidelity, and acceptability of the trial and intervention were evaluated using data recorded by therapists, observation of intervention and control sessions, interviews and one focus group. Patient measures of motor impairment, activities/participation, and quality of life were carried out by blinded assessors at baseline, 3, 15, 29, and 55 weeks post-randomisation. RESULTS: Forty-five participants (51–96 years; 42% male, mRS 4 = 80% 5 = 20%) were randomised (n = 22 to intervention). Twenty-seven (60%) participants were followed-up at all time points. Twelve participants (27%) died during the trial; no deaths were related to the trial. Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11). Intervention group: mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session 5 (SD 4). Interviews were conducted with 10 participants, four relatives and six physiotherapists. Five physiotherapists attended a focus group. CONCLUSIONS: The majority of progression criteria for this feasibility trial were met. However, adherence to the interventions was unacceptably low. This aspect of the trial design needs to be addressed prior to moving to a definitive RCT of this standing frame intervention in people with severe sub-acute stroke. Solutions have been identified to address these concerns. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15412695. Registration 19 December 2016. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01012-4.
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spelling pubmed-88927362022-03-10 Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial Logan, Angela Freeman, Jennifer Kent, Bridie Pooler, Jill Creanor, Siobhan Enki, Doyo Vickery, Jane Barton, Andrew Marsden, Jonathan Pilot Feasibility Stud Research BACKGROUND: Early mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separately been evaluated in the literature; however, these functionally linked tasks have not been evaluated in combination for people with severe sub-acute stroke. METHODS: The objective was to determine the feasibility of conducting a randomised controlled trial (RCT) of a functional standing frame programme compared with usual physiotherapy for people with severe sub-acute stroke. An assessor-blinded feasibility RCT with nested qualitative component (interviews and focus group) and process evaluation was adopted. Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England. Participants were randomised to receive either: (1) functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control). Both programmes were protocolised to be undertaken a minimum of five sessions per week for 3 weeks. Feasibility indicators included process, resource, management, and safety. Adherence, fidelity, and acceptability of the trial and intervention were evaluated using data recorded by therapists, observation of intervention and control sessions, interviews and one focus group. Patient measures of motor impairment, activities/participation, and quality of life were carried out by blinded assessors at baseline, 3, 15, 29, and 55 weeks post-randomisation. RESULTS: Forty-five participants (51–96 years; 42% male, mRS 4 = 80% 5 = 20%) were randomised (n = 22 to intervention). Twenty-seven (60%) participants were followed-up at all time points. Twelve participants (27%) died during the trial; no deaths were related to the trial. Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11). Intervention group: mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session 5 (SD 4). Interviews were conducted with 10 participants, four relatives and six physiotherapists. Five physiotherapists attended a focus group. CONCLUSIONS: The majority of progression criteria for this feasibility trial were met. However, adherence to the interventions was unacceptably low. This aspect of the trial design needs to be addressed prior to moving to a definitive RCT of this standing frame intervention in people with severe sub-acute stroke. Solutions have been identified to address these concerns. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15412695. Registration 19 December 2016. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01012-4. BioMed Central 2022-03-03 /pmc/articles/PMC8892736/ /pubmed/35241176 http://dx.doi.org/10.1186/s40814-022-01012-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Logan, Angela
Freeman, Jennifer
Kent, Bridie
Pooler, Jill
Creanor, Siobhan
Enki, Doyo
Vickery, Jane
Barton, Andrew
Marsden, Jonathan
Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title_full Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title_fullStr Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title_full_unstemmed Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title_short Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial
title_sort functional standing frame programme early after severe sub-acute stroke (spires): a randomised controlled feasibility trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8892736/
https://www.ncbi.nlm.nih.gov/pubmed/35241176
http://dx.doi.org/10.1186/s40814-022-01012-4
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