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This systematic review's purpose was to evaluate the effectiveness of lower-limb and foot somatosensory stimulation to improve balance and gait post-stroke. PRISMA reporting guidelines were followed. Included studies: randomized controlled trials (RCTs), published in English with ethical approval statement. Studies of conditions other than stroke, functional electrical stimulation, and interventions eliciting muscle contraction, were excluded. AgeLine, AMED, CINAHL PLUS, EMBASE, EMCARE MEDLINE, PEDro, PsycARTICLES, PsycINFO, SPORTDiscus, Web of Science and Cochrane central register of controlled trials were searched from 1 January 2002 to 31 March 2022. Two authors independently screened results, extracted data and assessed study quality using Cochrane Risk of Bias 2 tool; 16 RCTs (n = 638) were included. Four studies showed a medium or large standardized between-group effect size (Cohen's d) in favor of somatosensory stimulation, in relation to: customized insoles (d = 0.527), taping (d = 0.687), and electrical stimulation (two studies: d = 0.690 and d = 1.984). Although limited by study quality and heterogeneity of interventions and outcomes, with only one study's results statistically significant, several interventions showed potential for benefit, exceeding the minimally important difference for gait speed. Further research with larger trials is required. This unfunded systematic review was registered with PROSPERO (number CRD42022321199).
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BACKGROUND: Patient and public involvement (PPI) in research has increased steadily over the last two decades and is now both expected and appropriately resourced by many funding bodies, including the National Institute for Health Research (NIHR). However, PPI in research occurs in many different capacities and numerous frameworks exist for reporting or appraising patient involvement activities. The aim of this article is to describe processes involving PPI contributions to an NIHR-funded mixed-methods feasibility study (MoTaStim-Foot). Details of PPI advisors' input, from initial identification and prioritisation of research ideas, to research delivery and dissemination, are discussed. METHODS: Extensive PPI for MoTaStim-Foot is reported, with consideration of Research Design Service (RDS) advice for PPI for research, involving identifying and prioritising: design; grant proposal development; undertaking/managing research; analysing and interpreting; dissemination; implementation; monitoring and evaluation. Two PPI workshops were undertaken; success in meeting UK standards for public involvement was audited against specific success criteria by two researchers, with discussion and consideration regarding how well our PPI achieved inclusive opportunities, working together, support and learning, governance, communications and impact. How PPI can be improved for future trials was also considered. Although the advantages of PPI for researchers were considered, the benefits for PPI advisors were also analysed. RESULTS: UK standards for public involvement were achieved, along with seven relevant research processes suggested by the RDS. PPI advisor contributions: informed study design; contributed to successful funding; enhanced trial delivery by informing participant information sheets and daily diaries; added value through undertaking note-taker roles in focus groups and helping to analyse focus group transcripts; and assisted in dissemination. However, benefits were mutual with PPI advisors reporting feeling valued and respected, a sense of pride with renewed confidence and purpose in life. CONCLUSIONS: Importance and value of PPI, to researchers and patient advisors, have been highlighted, reinforcing the benefits of working in partnership with PPI advisors. Trial registration ISRCTN 13676183; Central Portfolio Management System ID 30449. Registered 02/01/2015, https://www.isrctn.com/ISRCTN13676183 .
This article reports and analyses our public involvement in the research processes for a study funded by the National Institute for Health Research, the MoTaStim-Foot feasibility study. MoTaStim-Foot explored whether it was feasible to deliver treatments to help people feel their foot better after stroke. The results of this study have been published elsewhere (1). Patient and Public Involvement (PPI) advisors played an important role. They worked voluntarily, actively advising the research team; the term 'PPI advisor' is used within this article, following consultation with our PPI advisors. They were involved during idea generation and discussions about whether the study was important to pursue. In addition, they advised the research team during the study setup helping to write the plain English summary, the participant information sheets and advised on other research activities. Following relevant training, PPI advisors were involved in delivering the research including note-taking during focus groups. One PPI advisor also helped analyse the focus group transcripts and attended the UK Stroke Forum to present the results of the study. Reflecting upon the impact of the PPI advisors' contributions to the MoTaStim-Foot study has evidenced that not only was there great benefit to the research team and process, but our PPI advisors gained satisfaction from being involved in the research, planning, design and delivery. It made them all feel valued and respected and helped one of them find a renewed purpose in life. It is important to understand there can be mutual benefit from PPI advisors' contributions to research.
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Background: Somatosensory stimulation of the lower extremity could improve motor recovery and walking post-stroke. This pilot study investigated the feasibility of a subsequent randomized controlled trial (RCT) to determine whether task-specific gait training is more effective following either (a) intensive hands-on somatosensory stimulation or (b) wearing textured insoles. Objectives: Determine recruitment and attrition rates, adherence to intervention, acceptability and viability of interventions and outcome measures, and estimate variance of outcome data to inform sample size for a subsequent RCT. Methods: Design: randomized, single-blinded, mixed-methods pilot study. Setting: In-patient rehabilitation ward and community. Participants: n = 34, 18+years, 42-112 days following anterior or posterior circulation stroke, able to follow simple commands, able to walk independently pre-stroke, and providing informed consent. Intervention: Twenty 30-min sessions of task-specific gait training (TSGT) (delivered over 6 weeks) in addition to either: (a) 30-60 min mobilization and tactile stimulation (MTS); or (b) unlimited textured insole (TI) wearing. Outcomes: Ankle range of movement (electrogoniometer), touch-pressure sensory thresholds (Semmes Weinstein Monofilaments), motor impairment (Lower Extremity Motricity Index), walking ability and speed (Functional Ambulation Category, 5-m walk test, pressure insoles) and function (modified Rivermead Mobility Index), measured before randomization, post-intervention, and 1-month thereafter (follow-up). Adherence to allocated intervention and actual dose delivered (fidelity) were documented in case report forms and daily diaries. Focus groups further explored acceptability of interventions and study experience. Analysis: Recruitment, attrition, and dose adherence rates were calculated as percentages of possible totals. Thematic analysis of daily diaries and focus group data was undertaken. Standard deviations of outcome measures were calculated and used to inform a sample size calculation. Results: Recruitment, attrition, and adherence rates were 48.57, 5.88, and 96.88%, respectively. Focus groups, daily-diaries and case report forms indicated acceptability of interventions and outcome measures to participants. The 5-m walk was selected as primary outcome measure for a future trial [mean (SD) at end of intervention: 16.86 (11.24) MTS group and 21.56 (13.57) TI group]; sample size calculation indicated 60 participants are required per group. Conclusion: Recruitment, attrition and adherence rates and acceptability of interventions and outcomes justify a subsequent powered RCT of MTS+TSGT compared with TI+TSGT.
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BACKGROUND: Public involvement in the education of students enrolled on higher education programmes has gained impetus. For students enrolled on professional health-care programmes and health-related modules in the UK, there is also a requirement by professional bodies to include "service user" involvement in preparation for entry to a professional health-care register and continuing professional development. Actively involving patients and members of the public in research is also a requirement by many research funders. In this article, the term Patient and Public Involvement (PPI) will be used throughout to include lay members, volunteers, user and carers. OBJECTIVES: A unique pilot study was introduced across a health faculty to integrate PPI in a deliberate way. It aimed to provide an educational, focused programme of events that was meaningful to develop and inform peoples' knowledge, skills and confidence for their involvement in the health faculty. DESIGN: PPI members volunteered to sit on a steering group to determine the educational journey; the outcomes of three focus groups with PPI members (N = 32) and academics informed the programme content which included a range of workshops covering the exploration of public roles and barriers to involvement, introduction to research and interviewing skills. RESULTS: The workshops were well attended, and outcomes indicated the importance of co-production when designing, delivering and evaluating programmes. DISCUSSION: Co-production underpinned this pilot study, resulting in a programme which was meaningfully received by public contributors. RECOMMENDATIONS: Co-production was seen as integral to this research to ensure that outcomes were indeed "fit for purpose".