Title: A feasibility study to investigate the effects of a functional standing frame programme in people with severe sub-acute stroke on function, quality of life and neuromuscular impairment; and a systematic review on non-pharmacological interventions for orthostatic hypotension.
Funder: Health Education England

Abstract: Background Stroke is the largest cause of complex adult disability in the UK affecting over 152,000 people per annum. The most common physical deficit caused by stroke is motor impairment which limits a person's mobility, ability to participate in activities of daily living (ADL) and live independently. Mobility encompasses activities necessary for ADL: getting in and out of bed, sitting, standing and walking. These activities are significantly affected in people with severe stroke who typically spend the majority of their time in bed/sitting. With the advent of Early Supported Discharge in the UK there is an increase in the proportion of people in Stroke Rehabilitation Units (SRUs) who have a severe stroke. Although immobility post-stroke is primarily caused by neurological damage it can lead to secondary complications (e.g. muscle wasting, reduced muscle length, muscle stiffness, joint contracture and orthostatic hypotension (OH)). Immobility due to the primary neurological deficit as well as secondary complications can theoretically be minimised by early mobilisation in standing. Due to the severity of the stroke this would require support in a standing frame which allows a person to undertake functional activities in standing. However, functional standing programmes are not routinely undertaken in SRUs for people with severe stroke where much of the therapy input is directed towards achieving tasks such as transferring that will facilitate discharge from the SRU. An additional difficulty post-stroke is OH that can occur in over 50% of people and can limit the ability to stand. Currently there are no guidelines for non-pharmacological interventions to treat OH post-stroke, therefore a systematic review will be undertaken to inform the development of a protocol for the treatment of OH that will be implemented in the feasibility study. Systematic Review Aims Identify the effectiveness of non-pharmacological interventions to treat OH in the elderly and people with a neurological condition Feasibility Study Aims Establish the feasibility of a Randomised Controlled Trial (RCT). The RCT aims to determine the effectiveness of functional standing practice in people with severe sub-acute stroke in improving functional ability and quality of life, OH and neuromuscular impairment. Study Design and Methods The systematic review will inform the development of a protocol for the non-pharmacological treatment of OH post-stroke for use in the feasibility study. A pragmatic multi-centred RCT with blinded outcome assessment will be adopted. Fifty people with severe stroke will be recruited from four different inpatient SRUs across Cornwall and Devon. Participants will be randomised into either functional standing frame practice (intervention) or usual physiotherapy (control). Participants in the intervention group will undertake functional activities in a standing frame for up to x5/week for 30 minutes during a 3-week period. An additional 15 minutes will provide time for usual care which may include activities chosen by participants or guided by physiotherapists (practising transfers, reviewing seating etc.). Participants in the control group will receive 45 minutes of usual physiotherapy. In both groups outcomes will be measured at baseline, immediately post-intervention and follow-up (3, 6 and 12 months). Outcome measures include: motor function, quality of life and fatigue, OH, lower limb muscle and joint range and muscle strength, muscle tone, trunk control and mood using clinically oriented, validated and reliable measures. The subjective experiences of the intervention will be explored qualitatively (16 participants, eight carers, and one or two clinicians from each site). If feasible this study will lead to a subsequent fully powered RCT which will evaluate the clinical and cost effectiveness of the intervention. This study will therefore contribute to the development of clinical guidelines and implementation of practice within the National Health Service.

Lay abstract: People with severe stroke experience significant muscle weakness which means that they spend much of their time in bed or sitting. This inactivity can cause their muscles to become even weaker and stiffer and may lead them to experience sudden drops in blood pressure when they move from lying to standing (orthostatic hypotension). This further interferes with their ability to participate in intensive stroke rehabilitation, overall recovery and quality of life. Currently physiotherapy for people with severe stroke concentrates on practicing tasks such as transfers in/out of a chair that are important for independence and achieving discharge home. Standing up early after a stroke may help strengthen muscles, reduce orthostatic hypotension and minimise or prevent muscles becoming stiff and weaker. Our research aims to assess whether it is possible for people with severe stroke to use a standing frame to practise functional movements such as standing and moving between sitting and standing. Our discussions with people who have had a severe stroke, identified that optimising function was a key priority. People highlighted how important it was to get up and get moving straight away; emphasising the importance they placed on standing and walking as soon as possible following their stroke. They believed it would help me get back to normal, and allow me to do things on my own. They told us that the aims of this research project were important, and reflected the needs of people who had experienced a severe stroke and were undergoing inpatient rehabilitation between one week to six months after their stroke. These discussions helped us to develop this proposal in a number of ways, for example by identifying and addressing barriers that may limit participation in this study (e.g. fatigue, exercise tolerance, communication difficulties). Clinicians also guided us in selecting the most suitable measures for this evaluation. Orthostatic hypotension is very common in elderly people and people with stroke; it frequently interferes with standing practice. We will firstly undertake a systematic review of the literature in this area. This will inform the development of a protocol for the treatment of orthostatic hypotension. For instance, wearing a compression garment such as stockings or an abdominal corset, may help optimise people's standing time and tolerance. This protocol will be used in the feasibility study if people present with orthostatic hypotension. The feasibility study will find out if it is possible and practical to use a functional standing frame programme in people with severe stroke in the sub-acute hospital setting. Fifty people with a severe stroke will be recruited from four different Stroke Rehabilitation Units in Cornwall and Devon. Using a computer programme, participants will be randomly allocated to either (1) Functional standing programme (30 minutes) and 15 minutes usual physiotherapy, or (2) 45 minutes usual physiotherapy management only. We will measure factors such as the rate of recruitment to the study, how many people drop out and the content of the usual physiotherapy treatment package. We will assess the effect of the interventions on measures of functional ability, quality of life and factors such as muscle weakness and stiffness. The person assessing each participant will not be aware of which treatment participants are receiving therefore, the study will be assessor blinded to minimise bias. We will assess the feasibility of undertaking these outcome measures and obtain an estimate of the size of any change with the intervention that will inform the development of a future main study. Patients who take part in the study and their carers/relatives will be interviewed, as will the clinicians involved. This will allow us to: identify the reasons why people decided whether or not to participate in the study; explore their experiences of the functional standing frame programme; and understand how participants felt about being randomly allocated into different groups. This will further inform development of the subsequent main study. To maximise impact, we will work with people with a stroke and carers to publicise the research findings in many different ways. We will publish in journals, via professional clinical networks, charity websites and newsletters such as the Stroke Association, Different Strokes, and Cornwall and Devon Stroke Services. There will also be a dedicated web page. Presentations will be made at relevant national and international conferences, and via local and regional Stroke Improvement Groups, regional clinician professional development training sessions and patient support group meetings across Cornwall and Devon. Social Media such as FaceBook and Twitter will be used to publish results in specific stroke, neurological rehabilitation and NHS provider pages.

Research activity codes: 6.7 PHYSICAL
Health categories: STROKE