Bespoke versus off-the-shelf ankle-foot orthosis for people with stroke: randomized controlled trial.

OBJECTIVE: The aim of the study was to compare the effect of two designs of ankle-foot orthosis on people with stroke. DESIGN: The study design was an assessor-blind, multicentre randomized controlled trial. SETTING: The setting was community stroke services. PARTICIPANTS: A total of 139 community-dwelling stroke survivors with limited mobility were recruited. INTERVENTIONS: The two most commonly used types of ankle-foot orthosis (bespoke and off-the-shelf) were chosen. MAIN MEASURES: The main measures of the study were as follows: short- (6 weeks) and long-term (12 weeks) effects on stroke survivors' satisfaction; adverse events; mobility (Walking Handicap Scale); fear of falling (Falls Efficacy Scale-International (FES-I)) and walking impairments (gait speed and step length using the 5-m walk test). RESULTS: Long-term satisfaction was non-significantly higher in the off-the-shelf group: 72% versus 64%; OR (95% CI) = 0.64 (0.31 to 1.3); P = 0.21. No statistically significant differences were found between the orthoses except that the off-the-shelf group had less fear of falling at short-term follow-up than the bespoke group: mean difference (95% CI) = -4.6 (-7.6 to -1.6) points on the FES-I; P = 0.003. CONCLUSION: No differences between off-the-shelf and bespoke ankle-foot orthoses were found except that participants in the off-the-shelf orthosis group had less fear of falling at short-term follow-up.

Health care professionals' views of the factors influencing the decision to refer patients to a stroke rehabilitation trial.

BACKGROUND: Effective recruitment is an essential element of successful research but notoriously difficult to achieve. This article examines health care professionals' views on the factors influencing decision-making regarding referral to a stroke rehabilitation trial. METHODS: Semi-structured interviews and a card-sorting task were undertaken with stroke service staff in acute and community hospital trusts. Data analysis used a thematic framework approach. RESULTS: Twenty-seven qualified health care professionals from 12 (6 acute and 6 community) hospital trusts and one charity participated. Four main factors emerged: patient-related, professional views, the organisation and research logistics, which all contributed to staff's decision about whether to refer patients to a trial. Clinicians identified patient-related factors as the most frequent influence and considered themselves the patients' advocate. They used their knowledge of the patient to anticipate the patients' reaction to possible participation and tended to only refer those whom they perceived would respond positively. Participants also identified experience of research, a sense of ownership of the project and a positive view of the intervention being evaluated as factors influencing referral. The need to prioritise clinical matters, meet managerial demands and cope with constant change were organisational factors impacting negatively on referral. Staff often simply forgot about recruitment in the face of other higher priorities. Quick, simple, flexible research processes that were closely aligned with existing ways of working were felt to facilitate recruitment. CONCLUSIONS: Patient- and professional-related factors were the most frequent influence on clinicians' recruitment decisions, which often had a 'gate-keeping' effect. Managerial and clinical responsibility to juggle multiple (often higher) priorities was also an important factor. To facilitate recruitment, researchers need to develop strategies to approach potential participants as directly as possible to enable them to make their own decisions about participation; ensure that research processes are as quick and simple as possible; align with existing clinical pathways and systems; and give regular reminders and ongoing support to promote recruitment. TRIAL REGISTRATION: ISRCTN, 98287938 . Registered 6 May 2015.

Recruiting to inpatient-based rehabilitation trials: lessons learned.

UNLABELLED: Effective recruitment is central to successful trials but is often problematic. This article reports the lessons learnt while recruiting stroke rehabilitation patients to a multi-centre randomised control trial. As intended, 94 participants were recruited from 12 inpatient stroke rehabilitation services in Northwest England over 12 months; however, recruitment rates were highly varied (from 0.6 to 2.5 participants per site per month) as were the nature of the stroke services and the personnel available. Consequently, bespoke recruitment procedures were needed at each site. As the assessment skills needed to screen for the selection criteria were specific to therapists, our most common strategy was for the hospital therapists to screen patients and make referrals directly to the trial team. However, we identified several strategies undertaken by the research nurse in the highest recruiting site that appeared to positively impact on recruitment. These strategies included involving the whole multidisciplinary team, being part of the stroke team, facilitating contact between the clinical and trial teams and using inclusive recruitment and watchful waiting strategies. Rehabilitation trials frequently require skilled assessments by therapists, rather than by doctors or nurses to identify potential participants. Thus, research support models need to include suitably skilled trial therapists. Recruitment can be enhanced by enthusiastic, regular and structured engagement with the entire stroke multidisciplinary team and by using inclusive recruitment and 'watchful waiting' strategies to identify and monitor potential participants. TRIAL REGISTRATION: ISRCTN29533052 . Registered May 2011.

Staff's views on delivering patient-led therapy during inpatient stroke rehabilitation: a focus group study with lessons for trial fidelity.

BACKGROUND: Fidelity to the treatment protocol is key to successful trials but often problematic. This article reports the staff's views on delivering a complex rehabilitation intervention: patient-led therapy during inpatient stroke care. METHODS: An exploratory qualitative study using focus groups with staff involved in a multicenter (n = 12) feasibility trial of patient-led therapy (the MAESTRO trial) was undertaken as part of the evaluation process. Purposive sampling ensured that participants represented all recruiting sites, relevant professions and levels of seniority. Data analysis used a Framework Approach. RESULTS: Five focus groups were held involving 30 participants. Five main themes emerged: the effect of the interventions, practical problems, patient-related factors, professional dilemmas, and skills. Staff felt the main effect of the therapies was on patients' autonomy and occupation; the main practical problems were the patients' difficulties in achieving the correct position and a lack of space. Staff clearly identified characteristics that made patient-led therapy unsuitable for some patients. Most staff experienced dilemmas over how to prioritize the trial interventions compared to their usual therapy and other clinical demands. Staff also lacked confidence about how to deliver the interventions, particularly when adapting the interventions to individual needs. For each barrier to implementation, possible solutions were identified. Of these, involving other people and establishing a routine were the most common. CONCLUSIONS: Delivering rehabilitation interventions within a trial is complex. Staff require time and support to develop the skills, strategies and confidence to identify suitable patients, deliver new treatments, adapt the new treatments to individuals' needs and balance the demands of delivering the trial intervention according to the treatment protocol with other clinical and professional priorities. ISRCTN: ISRCTN29533052 . October 2011.

Patient-directed therapy during in-patient stroke rehabilitation: stroke survivors' views of feasibility and acceptability.

PURPOSE: Patient-led therapy, in which patients work outside therapy sessions without direct supervision, is a possible way to increase the amount of therapy stroke patients' receive without increasing staff demands. Here, we report patients' views of patient-led mirror therapy and lower limb exercises. METHOD: 94 stroke survivors with upper and lower limb limitations at least 1-week post-stroke undertook 4 weeks of daily patient-led mirror therapy or lower limb exercise, then completed questionnaires regarding their experience and satisfaction. A convenience random sample of 20 participants also completed a semi-structured telephone interview to consider their experience in more detail and to capture their longer term impressions. RESULTS: Participants were generally positive about patient-led therapy. About 71% found it useful; 68% enjoyed it; 59% felt it "worked" and 88% would recommend it to other patients. Exercise was viewed more positively than the mirror therapy. Difficulties included arranging the equipment and their position, particularly for more severe strokes, loss of motivation and concerns about working unsupervised. CONCLUSIONS: Patient-led mirror therapy and lower limb exercises during in-patient rehabilitation is generally feasible and acceptable to patients but "light touch" supervision to deal with any problems, and strategies to maintain focus and motivation are needed. Implications for Rehabilitation Most stroke patients receive insufficient therapy to maximize recovery during rehabilitation. As increases in staffing are unlikely there is an imperative to find ways for patients to increase the amount of exercise and practice of functional tasks they undertake without increasing demands on staff. Patient-led therapy (also known as patient-directed therapy or independent practice), in which patients undertake exercises or functional tasks practice prescribed by a professional outside formal therapy sessions is one way of achieving this. It is widely used in community-based rehabilitation but is uncommon in hospital-based stroke care. We explored the feasibility and acceptability of two types of patient-led therapy during hospital-based stroke care; mirror therapy for the upper limb and exercises (without a mirror) for the lower limb. Here, we report patients' experiences of undertaking patient-led therapy. Patient-led mirror therapy and lower limb exercises during in-patient stroke rehabilitation is generally feasible and acceptable to patients but "light touch" supervision to deal with any problems, and strategies to maintain focus and motivation are needed.

Phase II Pragmatic Randomized Controlled Trial of Patient-Led Therapies (Mirror Therapy and Lower-Limb Exercises) During Inpatient Stroke Rehabilitation.

BACKGROUND AND OBJECTIVE: Patient-led therapy has the potential to increase the amount of therapy patients undertake during stroke rehabilitation and to enhance recovery. Our objective was to assess the feasibility and acceptability of 2 patient-led therapies during the acute stages of stroke care: mirror therapy for the upper limb and lower-limb exercises for the lower limb. METHODS: This was a blind assessed, multicenter, pragmatic randomized controlled trial of patient-led upper-limb mirror therapy and patient-led lower leg exercises. Stroke survivors with upper and lower limb limitations, undergoing inpatient rehabilitation and able to consent were recruited at least 1 week poststroke. RESULTS: Both interventions proved feasible, with >90% retention. No serious adverse events were reported. Both groups did less therapy than recommended; typically 5 to 15 minutes for 7 days or less. Participants receiving mirror therapy (n = 63) tended to do less practice than those doing lower-limb exercises (n = 31). Those with neglect did 69% less mirror therapy than those without (P = .02), which was not observed in the exercise group. Observed between-group differences were modest but neglect, upper-limb strength, and dexterity showed some improvement in the mirror therapy group. No changes were seen in the lower-limb group. CONCLUSIONS: Both patient-led mirror therapy and lower-limb exercises during inpatient stroke care are safe, feasible, and acceptable and warrant further investigation. Practice for 5 to 15 minutes for 7 days is a realistic prescription unless strategies to enhance adherence are included.