Delphi consensus study and clinical practice guideline development for functional electrical stimulation to support upright mobility in people with an upper motor neuron lesion.

PURPOSE: A Clinical Practice Guideline (CPG) is required to provide guidance on optimal service delivery for Functional Electrical Stimulation (FES) to support upright mobility in people living with mobility difficulties due to an upper motor neuron lesion, such as stroke or multiple sclerosis. A modified Delphi consensus study was used to provide expert consensus on best practice. METHODS: A Steering Group supported the recruitment of an Expert Panel, which included a range of stakeholders who participated in up to three survey rounds. In each round, panelists were asked to rate their agreement with draft statements about best practice using a 6-point Likert scale and add free text to explain their answer. Statements that achieved over 75% agree/strongly agree on the Likert scale were included in the CPG. Those that did not were revised based on free text comments and proposed in the next survey round. RESULTS: The first round included 82 statements with seven substatements. Sixty-five people (84% response rate) completed survey round 1 leading to 62 statements and four substatements being accepted. Fifty-six people responded to survey round 2, and consensus was achieved for all remaining statements. CONCLUSION: The accepted statements are included within the CPG and provide recommendations about who can benefit from FES and how they can be optimally supported through FES service provision. As such the CPG will support advocacy for, and optimal design of, FES services.

Is functional electrical stimulation effective in improving walking in adults with lower limb impairment due to an upper motor neuron lesion? An umbrella review.

PURPOSE: To conduct an umbrella review of systematic reviews on functional electrical stimulation (FES) to improve walking in adults with an upper motor neuron lesion. METHODS: Five electronic databases were searched, focusing on the effect of FES on walking. The methodological quality of reviews was evaluated using AMSTAR2 and certainty of evidence was established through the GRADE approach. RESULTS: The methodological quality of the 24 eligible reviews (stroke, n = 16; spinal cord injury (SCI), n = 5; multiple sclerosis (MS); n = 2; mixed population, n = 1) ranged from critically low to high. Stroke reviews concluded that FES improved walking speed through an orthotic (immediate) effect and had a therapeutic benefit (i.e., over time) compared to usual care (low certainty evidence). There was low-to-moderate certainty evidence that FES was no better or worse than an Ankle Foot Orthosis regarding walking speed post 6 months. MS reviews concluded that FES had an orthotic but no therapeutic effect on walking. SCI reviews concluded that FES with or without treadmill training improved speed but combined with an orthosis was no better than orthosis alone. FES may improve quality of life and reduce falls in MS and stroke populations. CONCLUSION: FES has orthotic and therapeutic benefits. Certainty of evidence was low-to-moderate, mostly due to high risk of bias, low sample sizes, and wide variation in outcome measures. Future trials must be of higher quality, use agreed outcome measures, including measures other than walking speed, and examine the effects of FES for adults with cerebral palsy, traumatic and acquired brain injury, and Parkinson's disease.

Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.

Introduction: A multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies. Methods: A constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed. Results: Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named "the Ideal Scenario" was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture. Conclusion: Novel explanatory theory is proposed with relevance for Implementation Science. The "Ideal Scenario" is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.

Support after COVID-19 study: a mixed-methods cross-sectional study to develop recommendations for practice.

Objectives of study stage 1 were to: explore people's experiences of illness due to COVID-19 while feeling socially isolated or socially isolating; identify perceptions of what would support recovery; and synthesise insights into recommendations for supporting people after COVID-19. Study stage 2 objectives were to engage stakeholders in evaluating these recommendations and analyse likely influences on access to the support identified. DESIGN: A two-stage, multimethod cross-sectional study was conducted from a postpositivist perspective. Stage 1 included an international online survey of people's experiences of illness, particularly COVID-19, in isolation (n=675 full responses). Stage 2 involved a further online survey (n=43), two tweetchats treated as large online focus groups (n=60 and n=27 people tweeting), two smaller focus groups (both n=4) and one interview (both using MS teams). SETTING: Stage 1 had an international emphasis, although 87% of respondents were living in the UK. Stage 2 focused on the UK. PARTICIPANTS: Anyone aged 18+ and able to complete a survey in English could participate. Stage 2 included health professionals, advocates and people with lived experience. MAIN OUTCOME MEASURES: Descriptive data and response categories derived from open responses to the survey and the qualitative data. RESULTS: Of those responding fully to stage 1 (mean age 44 years); 130 (19%) had experienced COVID-19 in isolation; 45 had recovered, taking a mean of 5.3 (range 1-54) weeks. 85 did not feel they had recovered; fatigue and varied 'other' symptoms were most prevalent and also had most substantial negative impacts. Our draft recommendations were highly supported by respondents to stage 2 and refined to produce final recommendations. CONCLUSIONS: Recommendations support access to progressive intensity and specialism of support, addressing access barriers that might inadvertently increase health inequalities. Multidisciplinary collaboration and learning are crucial, including the person with COVID-19 and/or Long Covid in the planning and decision making throughout.

Person-Centered Healthcare Practice in a Pandemic Context: An Exploration of People's Experience of Seeking Healthcare Support.

Background: The recent COVID-19 pandemic increased pressure upon healthcare resources resulting in compromised health services. Enforced national lockdown led to people being unable to access essential services in addition to limiting contact with social support networks. The novel coronavirus, and subsequent condition known as long covid were not well-understood and clinicians were not supported by existing guidelines or pathways. Our study explored people's experiences of healthcare during this period with a person-centered "lens." Methods: Ninety-seven people participated in our online survey about their experiences of the pandemic, particularly while socially isolated and their experiences of healthcare. Following completion of the survey, 11 of these participants agreed to further semi-structured interviews to explore this further in their own words. Interview conversations were transcribed, checked; together with the responses to open questions in the survey. The data were then analyzed thematically by members of the research team. We conducted framework analysis from a post-positivist perspective, using the Person-centered Practice Framework to explore participants' experiences. Results: There were few examples of people describing person-centered care. People experienced barriers to accessing support, and negative experiences of care that represented complexities enacting person-centered care at each level of the framework (processes, practice environment, prerequisites, and macro context). These barriers were influenced greatly by the pandemic, for example, with health professionals being harder to access. Some experiences related to the ways in which health professionals responded to the context, for example, positive examples included active listening, recognition of people's experiences, seeking to find out more, and engaging in collaborative problem-solving. Discussion: People want to feel heard, supported to navigate healthcare systems, source trustworthy information, find appropriate services, and collaborate in learning and problem-solving with healthcare professionals. There have been enormous challenges to the provision of healthcare throughout the pandemic. Moving forward is crucial with emphasis on overcoming barriers to person-centered healthcare. This should focus on steps now and also in planning for the possibility of further rapid changes in the demand for and provision of healthcare.

An investigation into the minimum accelerometry wear time for reliable estimates of habitual physical activity and definition of a standard measurement day in pre-school children.

The purpose of this study was to determine the number of hours and days of accelerometry data necessary to provide a reliable estimate of habitual physical activity in pre-school children. The impact of a weekend day on reliability estimates was also determined and standard measurement days were defined for weekend and weekdays.Accelerometry data were collected from 112 children (60 males, 52 females, mean (SD) 3.7 (0.7)yr) over 7 d. The Spearman-Brown Prophecy formula (S-B prophecy formula) was used to predict the number of days and hours of data required to achieve an intraclass correlation coefficient (ICC) of 0.7. The impact of including a weekend day was evaluated by comparing the reliability coefficient (r) for any 4 d of data with data for 4 d including one weekend day.Our observations indicate that 3 d of accelerometry monitoring, regardless of whether it includes a weekend day, for at least 7 h d(-1) offers sufficient reliability to characterise total physical activity and sedentary behaviour of pre-school children. These findings offer an approach that addresses the underlying tension in epidemiologic surveillance studies between the need to maintain acceptable measurement rigour and retention of a representatively meaningful sample size.

Measurement of lower limb volume: agreement between the vertically oriented perometer and a tape measure method.

OBJECTIVE: To investigate the agreement between lower limb volume measurements for the vertically oriented perometer and a tape measure method. DESIGN: Between-methods agreement and test-retest reliability study. SETTING: University setting. PARTICIPANTS: Thirty university staff and students were recruited using convenience sampling with no participant drop-outs. INTERVENTIONS: All participants' dominant lower limb volumes were measured using the vertically oriented perometer and a tape measure method. MAIN OUTCOME MEASURES: The Bland-Altman difference plot was reported for determining the bias between the two methods and its 95% confidence interval. Test-retest reliability and the measurement error for the perometer method were determined using the ICC(2,1) model and within-subject standard deviation (sw) respectively. RESULTS: There was a lack of agreement between the tape measure and perometer method. The Bland-Altman difference plot showed that the tape measure method overestimated limb volume by 157ml compared to the perometer method. A 95% confidence interval of -834ml to 519ml was observed. The test-retest reliability of the perometer method was ICC(2,1)=0.99. The measurement error of the perometer method was clinically acceptable (sw=121ml). CONCLUSIONS: There was a lack of agreement between the two methods investigated. Therefore the perometer and tape measure methods are not interchangeable. It is recommended that future validity and reliability studies for the vertically oriented perometer are conducted on clinical populations.

The effects and experiences of goal setting in stroke rehabilitation - a systematic review.

OBJECTIVE: To systematically integrate and appraise the evidence for effects and experiences of goal setting in stroke rehabilitation. DESIGN: Systematic review of quantitative and qualitative studies. METHODS: Relevant databases were searched from start of database to 30 April 2011. Studies of any design employing goal setting, reporting stroke-specific data and evaluating its effects and/ or experiences were included. RESULTS: From a total of 53998 hits, 112 full texts were analysed and 17 studies were included, of which seven evaluated effects while ten explored experiences of goal setting. No eligible randomized controlled trials were identified. Most of the included studies had weak to moderate methodological strengths. The design, methods of goal setting and outcome measures differed, making pooling of results difficult. Goal setting appeared to improve recovery, performance and goal achievement, and positively influenced patients' perceptions of self-care ability and engagement in rehabilitation. However, the actual extent of patient involvement in the goal setting process was not made clear. Patients were often unclear about their role in this process. Professionals reported higher levels of collaboration during goal setting than patients. Patients and professionals differed on how they set goals, types of goals set, and on how they perceived goal attainment. Barriers to goal setting outnumbered the facilitators. CONCLUSION: Due to the heterogeneity and quality of included studies, no firm conclusions could be made on the effectiveness, feasibility and acceptability of goal setting in stroke rehabilitation. Further rigorous research is required to strengthen the evidence base. Better collaboration and communication between patients and professionals and relevant education are recommended for best practice.

Comparison of accelerometry cut points for physical activity and sedentary behavior in preschool children: a validation study.

This study compared accelerometry cut points for sedentary behavior, light and moderate to vigorous intensity activity (MVPA) against a criterion measure, the Children's Activity Rating Scale (CARS), in preschool children. Actigraph accelerometry data were collected from 31 children (4.4 ± 0.8 yrs) during one hour of free-play. Video data were coded using the CARS. Cut points by Pate et al., van Cauwenberghe et al., Sirard et al. and Puyau et al. were applied to calculate time spent in sedentary, light and MVPA. Repeated-measures ANOVA and paired t tests tested differences between the cut points and the CARS. Bland and Altman plots tested agreement between the cut points and the CARS. No significant difference was found between the CARS and the Puyau et al. cut points for sedentary, light and MVPA or between the CARS and the Sirard et al. cut point for MVPA. The present study suggests that the Sirard et al. and Puyau et al. cut points provide accurate group-level estimates of MVPA in preschool children.

Experiences of an exercise referral scheme from the perspective of people with chronic stroke: a qualitative study.

OBJECTIVE: To explore stroke survivors' experiences of undertaking exercise in the context of an exercise referral scheme for people with chronic stroke. DESIGN: A qualitative design, using semi-structured interviews within a constructivist framework to explore the experiences of individual participants. Verbatim transcripts were thematically analysed. Rigour mechanisms included respondent validation, peer checking, and reflexivity. SETTING: An exercise referral scheme, based at a leisure centre in South London. PARTICIPANTS: Nine community-dwelling stroke survivors took part; 5 male and 4 female, mean age 51 years (range 37-61 years); time post stroke 1-4 years, with mixed ethnic backgrounds. FINDINGS: Participants described greater physical and psychological well-being following participation in the exercise referral scheme. Categories that emerged were: improved exercise engagement and confidence, more internalised perceptions of control and enhanced lifestyle, work and social roles. Categories linked to form a master theme, labelled: 'Exercise Referral Scheme as a catalyst for regaining independence.' CONCLUSIONS: This study supports the value of exercise referral schemes in enabling people with stroke to engage in exercise. For participants in this study, the scheme seemed influential in the process of regaining independence.

Comparison of epoch and uniaxial versus triaxial accelerometers in the measurement of physical activity in preschool children: a validation study.

The objectives of this study were to explore whether triaxial is more accurate than uniaxial accelerometry and whether shorter sampling periods (epochs) are more accurate than longer epochs. Physical activity data from uniaxial and triaxial (RT3) devices were collected in 1-s epochs from 31 preschool children (15 males, 16 females, 4.4 ± 0.8 yrs) who were videoed while they engaged in 1-hr of free-play. Video data were coded using the Children's Activity Rating Scale (CARS). A significant difference (p < .001) in the number of minutes classified as moderate to vigorous physical activity (MVPA) was found between the RT3 and the CARS (p < .002) using the cut point of relaxed walk. No significant difference was found between the GT1M and the CARS or between the RT3 and the CARS using the cut point for light jog. Shorter epochs resulted in significantly greater overestimation of MVPA, with the bias increasing from 0.7 mins at 15-s to 3.2 mins at 60-s epochs for the GT1M and 0 mins to 1.7 mins for the RT3. Results suggest that there was no advantage of a triaxial accelerometer over a uniaxial model. Shorter epochs result in significantly higher number of minutes of MVPA with smaller bias relative to direct observation.

"Functional electrical stimulation (FES) impacted on important aspects of my life": a qualitative exploration of chronic stroke patients' and carers' perceptions of FES in the management of dropped foot.

Our purpose was to explore the impact of functional electrical stimulation (FES), as applied in the management of dropped foot, on patients with chronic stroke and their carers. A qualitative phenomenological study was undertaken. Participants were recruited from the Lothian FES clinic. Data were collected by using semistructured face-to-face interviews and analysed by using the framework of interpretative phenomenological analysis (IPA). Thirteen patients and nine carers consented to participate in the study. The overarching theme that emerged from the data was that "FES impacted on important aspects of my life." Four subthemes were identified: 1) "Walking with FES is much better"; 2) "FES helped regain control of life"; 3) "Feeling good comes with using FES"; and 4) "FES is not perfect but it is of value." This study provides insights into the perceptions of patients and carers of the impact of FES. These results have implications for clinicians delivering an FES service for the management of dropped foot after stroke.

A mixed methods service evaluation of a pilot functional electrical stimulation clinic for the correction of dropped foot in patients with chronic stroke.

AIM: To undertake a service evaluation of the pilot Lothian functional electrical stimulation (FES) clinic using both quantitative and qualitative methods and clinical practice reflection. BACKGROUND: Clinical guidelines recommend that FES, for the management of dropped foot after stroke, is delivered by a specialist team. However, little detail is provided about the structure and composition of the specialist team or model of service delivery. A pilot Lothian FES clinic was developed to explore the clinical value of providing such a service to stroke patients with dropped foot and identify any service modifications. METHODS: Mixed methods were used to evaluate the service and included quantitative, qualitative and reflective components. Phase 1: Before and after service evaluation of patients attending the FES clinic between 2003 and 2007. Outcomes of gait velocity and cadence were recorded at initial clinic appointment and 6 months after application of FES. Phase 2: Qualitative research exploring patients with stroke and carers' experiences of the FES clinic. Data were collected via semi-structured interviews. Phase 3: A reflection on the service delivery model. PARTICIPANTS: Phase 1: 40 consecutive out-patients with stroke; Phase 2: 13 out-patients with stroke and 9 carers; Phase 3: Three specialist physiotherapists engaged in running the FES clinic. FINDINGS: Statistically significant improvements (p < 0.001) were demonstrated in gait velocity and cadence. Qualitatively, one super-ordinate theme 'The FES clinic met my needs' emerged. Within this were four sub-themes, namely 1. 'Getting to grips with FES wasn't difficult'; 2. 'It's great to know they're there'; 3. 'Meeting up with others really helps' and 4. 'The service is great but could be better'. On reflection, minor modifications were made to the service delivery model but overall the service met user needs. This dedicated FES clinic produced positive physical outcomes and met the needs of this chronic stroke population.

Carer experiences of life after stroke - a qualitative analysis.

AIMS AND OBJECTIVES: Carers' experiences of caring for a stroke survivor were explored, including reactions and changes in their lives. METHOD: A phenomenological approach was taken to the collection and analysis of data. Semi-structured interviews lasting an average of 43 min were carried out with nine informal carers in their own homes. All were married to someone who had survived a stroke. RESULTS: An overarching theme emerged, entitled: 'lives turned upside-down'. It took time for participants to understand the long-term impacts of stroke. Carers experienced increased caring and domestic workloads alongside reduced participation and altered expectations of life. They found emotional and cognitive changes in their partners particularly distressing, and would have valued more information and help with adjusting to the increased emotional, physical and cognitive workload of caring. CONCLUSIONS: It is important to support carers of people who have survived a stroke in adjusting to their changed lifestyles. This may affect their quality of life as well as sustainability of caring, and requires further research.

What do patients feel they can do following lumbar microdiscectomy? A qualitative study.

PURPOSE: Lumbar microdiscectomy is becoming increasingly popular in the management of prolapsed intervertebral disc. The early stage of rehabilitation has been under-researched, with little documented about optimal activity levels during the initial six weeks. This study aimed to gain insight into patients' experiences of physiotherapy and activity choices during this period. METHOD: Eight participants were chosen purposively. All had undergone an uncomplicated lumbar microdiscectomy in the preceding six weeks in an acute neurosurgical unit in the Northeast of England. One-to-one semi-structured interviews were conducted in the participants' homes and transcribed. Data were thematically analysed within a constructionist framework. Mechanisms to ensure analytical rigour were implemented. RESULTS: Three major themes were derived inductively from the data. The first, 'wish for precise movement boundaries,' described participants reduced levels of activity postoperatively as being related to high levels of anxiety about the surgery and fear of re-injury. The second theme suggested that physiotherapy failed to help participants explore their potential for activity. The final theme described post-operative fatigue. CONCLUSIONS: High levels of postoperative anxiety about movement and activity were not addressed postoperatively. This has significant clinical implications and highlights the need for further research.