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Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial.
Pilot Feasibility Stud. 2018; 4:66.PF

Abstract

Background

The most common physical deficit caused by a stroke is muscle weakness which limits a person's mobility. Mobility encompasses activities necessary for daily functioning: getting in and out bed, on/off toilet, sitting, standing and walking. These activities are significantly affected in people with severe stroke who typically spend most of their time in bed or a chair and are immobile. Immobility is primarily caused by neurological damage but exacerbated by secondary changes in musculoskeletal and cardiorespiratory systems. These secondary changes can theoretically be prevented or minimised by early mobilisation, in this case standing up early post-stroke.Standing up early post-stroke has been identified as an important priority for people who have suffered a severe stroke. However, trials of prolonged passive standing have not demonstrated any functional improvements. Conversely, task-specific training such as repeated sit-to-stand has demonstrated positive functional benefits. This feasibility trial combines prolonged standing and task-specific strength training with the aim of determining whether this novel combination of physiotherapy interventions is feasible for people with severe stroke as well as the overall feasibility of delivering the trial.

Methods/design

This is a pragmatic multi-centre parallel single-blinded two-armed feasibility randomised controlled trial. Fifty people with a diagnosis of severe stroke will be randomly allocated to either the functional standing frame programme or usual physiotherapy. All patient participants will be assessed at baseline and followed up at 3 weeks, then 3, 6 and 12 months post-randomisation. Trial objectives are to determine the feasibility according to the following indicators:: (i) Process: recruitment and retention rate, ability to consent, eligibility criteria, willingness/ability of physiotherapists to recruit, willingness of patients to be randomised, and acceptability of the intervention; (ii) Resource: burden and potential costs; (iii) Management: treatment fidelity, participant adherence, acceptability and completeness of outcome measures, impact and management or orthostatic hypotension; and (iv) Safety: number and nature of adverse and serious adverse events.

Discussion

The functional standing frame programme addresses a key concern for people who have suffered a severe stroke. However, several uncertainties exist which need to be understood prior to progressing to a full-scale trial, including acceptability and tolerance of the functional standing frame programme intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties.

Trial registration

International Standard Randomised Controlled Trial Number ISRCTN15412695. Registration on 19 December 2016.

Authors+Show Affiliations

1Faculty of Health and Human Sciences, School of Health Professions, Peninsula Allied Health Centre, Plymouth University, Derriford Rd, Plymouth, PL6 8BH UK.1Faculty of Health and Human Sciences, School of Health Professions, Peninsula Allied Health Centre, Plymouth University, Derriford Rd, Plymouth, PL6 8BH UK.2School of Nursing and Midwifery, Plymouth University, Room 405, Rolle Building, Drake Circus, Plymouth, Devon PL4 8AA UK.3Peninsula Schools of Medicine and Dentistry, Rooms 14 & 15, ITTC Building Research Way, Plymouth, PL6 8BU UK.4Peninsula Clinical Trials Unit (PenCTU), Plymouth University Peninsula Schools of Medicine and Dentistry, Room N16, Plymouth Science Park, Plymouth, PL6 8BX UK. 5Medical Statistics, Peninsula Schools of Medicine and Dentistry, Room N15, Plymouth Science Park, Plymouth, PL6 8BX UK.4Peninsula Clinical Trials Unit (PenCTU), Plymouth University Peninsula Schools of Medicine and Dentistry, Room N16, Plymouth Science Park, Plymouth, PL6 8BX UK.5Medical Statistics, Peninsula Schools of Medicine and Dentistry, Room N15, Plymouth Science Park, Plymouth, PL6 8BX UK.6National Institute for Health Research, Research Design Service, Peninsula Schools of Medicine and Dentistry, ITTC Building, Plymouth Science Park, Plymouth, PL6 8BX UK.1Faculty of Health and Human Sciences, School of Health Professions, Peninsula Allied Health Centre, Plymouth University, Derriford Rd, Plymouth, PL6 8BH UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29588861

Citation

Logan, Angie, et al. "Standing Practice in Rehabilitation Early After Stroke (SPIRES): a Functional Standing Frame Programme (prolonged Standing and Repeated Sit to Stand) to Improve Function and Quality of Life and Reduce Neuromuscular Impairment in People With Severe Sub-acute Stroke-a Protocol for a Feasibility Randomised Controlled Trial." Pilot and Feasibility Studies, vol. 4, 2018, p. 66.
Logan A, Freeman J, Kent B, et al. Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud. 2018;4:66.
Logan, A., Freeman, J., Kent, B., Pooler, J., Creanor, S., Vickery, J., Enki, D., Barton, A., & Marsden, J. (2018). Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial. Pilot and Feasibility Studies, 4, 66. https://doi.org/10.1186/s40814-018-0254-z
Logan A, et al. Standing Practice in Rehabilitation Early After Stroke (SPIRES): a Functional Standing Frame Programme (prolonged Standing and Repeated Sit to Stand) to Improve Function and Quality of Life and Reduce Neuromuscular Impairment in People With Severe Sub-acute Stroke-a Protocol for a Feasibility Randomised Controlled Trial. Pilot Feasibility Stud. 2018;4:66. PubMed PMID: 29588861.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial. AU - Logan,Angie, AU - Freeman,Jennifer, AU - Kent,Bridie, AU - Pooler,Jillian, AU - Creanor,Siobhan, AU - Vickery,Jane, AU - Enki,Doyo, AU - Barton,Andrew, AU - Marsden,Jonathan, Y1 - 2018/03/23/ PY - 2017/06/07/received PY - 2018/02/19/accepted PY - 2018/3/29/entrez PY - 2018/3/29/pubmed PY - 2018/3/29/medline KW - Early mobilisation KW - Feasibility randomised controlled trial KW - Function KW - Neuromuscular impairment KW - Physiotherapy KW - Stroke KW - Supported standing SP - 66 EP - 66 JF - Pilot and feasibility studies JO - Pilot Feasibility Stud VL - 4 N2 - Background: The most common physical deficit caused by a stroke is muscle weakness which limits a person's mobility. Mobility encompasses activities necessary for daily functioning: getting in and out bed, on/off toilet, sitting, standing and walking. These activities are significantly affected in people with severe stroke who typically spend most of their time in bed or a chair and are immobile. Immobility is primarily caused by neurological damage but exacerbated by secondary changes in musculoskeletal and cardiorespiratory systems. These secondary changes can theoretically be prevented or minimised by early mobilisation, in this case standing up early post-stroke.Standing up early post-stroke has been identified as an important priority for people who have suffered a severe stroke. However, trials of prolonged passive standing have not demonstrated any functional improvements. Conversely, task-specific training such as repeated sit-to-stand has demonstrated positive functional benefits. This feasibility trial combines prolonged standing and task-specific strength training with the aim of determining whether this novel combination of physiotherapy interventions is feasible for people with severe stroke as well as the overall feasibility of delivering the trial. Methods/design: This is a pragmatic multi-centre parallel single-blinded two-armed feasibility randomised controlled trial. Fifty people with a diagnosis of severe stroke will be randomly allocated to either the functional standing frame programme or usual physiotherapy. All patient participants will be assessed at baseline and followed up at 3 weeks, then 3, 6 and 12 months post-randomisation. Trial objectives are to determine the feasibility according to the following indicators:: (i) Process: recruitment and retention rate, ability to consent, eligibility criteria, willingness/ability of physiotherapists to recruit, willingness of patients to be randomised, and acceptability of the intervention; (ii) Resource: burden and potential costs; (iii) Management: treatment fidelity, participant adherence, acceptability and completeness of outcome measures, impact and management or orthostatic hypotension; and (iv) Safety: number and nature of adverse and serious adverse events. Discussion: The functional standing frame programme addresses a key concern for people who have suffered a severe stroke. However, several uncertainties exist which need to be understood prior to progressing to a full-scale trial, including acceptability and tolerance of the functional standing frame programme intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties. Trial registration: International Standard Randomised Controlled Trial Number ISRCTN15412695. Registration on 19 December 2016. SN - 2055-5784 UR - https://www.unboundmedicine.com/medline/citation/29588861/Standing_Practice_In_Rehabilitation_Early_after_Stroke__SPIRES_:_a_functional_standing_frame_programme__prolonged_standing_and_repeated_sit_to_stand__to_improve_function_and_quality_of_life_and_reduce_neuromuscular_impairment_in_people_with_severe_sub_acute_stroke_a_protocol_for_a_feasibility_randomised_controlled_trial_ L2 - https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0254-z DB - PRIME DP - Unbound Medicine ER -
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