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

Abstract

BackgroundThe 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/designThis 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.DiscussionThe 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 registrationInternational Standard Randomised Controlled Trial Number ISRCTN15412695. Registration on 19 December 2016.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0254-z) contains supplementary material, which is available to authorized users.

Early effects of a knee-ankle-foot orthosis on static standing balance in people with subacute stroke

“…Increasing physical activity may also be an important factor to promote improvements in post-stroke disability. Furthermore, to perform standing exercises early after stroke onset, is important to prevent or minimize secondary changes of the musculoskeletal and cardiorespiratory systems by immobility31 ) . However, many people with severe stroke require maximum physical assistance to perform standing and often have fewer opportunities to perform standing activities in daily living and rehabilitation.…”

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

“…Patients were eligible if they had a confirmed clinical diagnosis of new (first/recurrent) severe stroke, aged ≥ 18 years and graded as modified Rankin (mRS) 4 or 5. Full details of inclusion and exclusion criteria are given in the published trial protocol [ 23 ].…”

“…OH was defined as a decrease in systolic blood pressure (BP) of ≥ 20 mmHg, or a reduction in diastolic BP of ≥ 10 mmHg when moving from a supine position to an upright posture, or from sitting to standing. Full details are given in the published trial protocol [ 23 ].…”

Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis

“…Of the 87 full-text articles, 17 primary investigators were contacted to verify if their trial suited our inclusion criteria or for further extraction of patient data. Eleven trialists responded, resulting in the conclusion that six of the trials did not fit our inclusion criteria [58][59][60][61][62][63]. Six trialists and their affiliated institutions did not respond [64][65][66][67][68][69].…”