A sock for foot-drop: A preliminary study on two chronic stroke patients

Background: Foot-drop is a common motor impairment of chronic stroke patients, which may be addressed with an ankle foot orthosis. Although there is reasonable evidence of effectiveness for ankle foot orthoses, user compliance is sometimes poor. This study investigated a new alternative to the ankle foot orthosis, the dorsiflex sock. Case description and methods: The dorsiflex sock was evaluated using an A-B single case experimental design. Two community-dwelling, chronic stroke patients with foot-drop participated in this study. Measures were selected to span the International Classification of Function, Disability and Health domains and user views on the dorsiflex sock were also collected. Findings and outcomes: The dorsiflex sock was not effective in improving participants’ walking symmetry, speed or energy expenditure. Participant 1 showed improvement in the distance he could walk in 6 min when using the dorsiflex sock, but this was in keeping with a general improvement trend over the course of this study. However, both participants viewed the dorsiflex sock positively and reported a positive effect on their walking. Conclusion: Despite positive user perceptions, the study found no clear evidence that dorsiflex sock is effective in improving foot-drop. Clinical relevance Although the dorsiflex sock offers an attractive alternative to an ankle foot orthosis, the case studies found no clear evidence of its efficacy. Clinicians should view this device with caution until further research becomes availabl

The evaluation of and comparative evidence for two types of interventional devices for foot-drop of central neurological origin

Introduction This thesis focusses on ankle foot orthoses (AFO) and functional electrical stimulation (FES) for the correction of foot-drop. It consists of two parts linked through identification of three gaps in the knowledge base: 1) limitations in device design, 2) limitations in device evaluation and 3) a lack of clear clinical guidance surrounding which of the two devices to use. Methods and Results PART 1 reports on the design and evaluation of an AFO alternative (dorsiflex sock) and an alternative to conventional FES systems (ShefStim®). Article 1 reports the evaluation of the researcher/user co-design approach used in the development of both devices, finding that lay-advisory involvement guided aspects such as where to locate the stimulator and informed the revision of the evaluation studies. Article 2 used a single case experimental design with 2 stroke participants to preliminarily explore the efficacy and user views of the dorsiflex sock. It found no clear evidence to demonstrate that the dorsiflex sock with its current design was effective, despite user views to the contrary. Article 3 reported on the feasibility of ShefStim®. Seven current foot-drop FES users used ShefStim® unsupervised for two weeks at home, alongside gait laboratory testing of foot-clearance and kinematics at initial contact. Number of heel rises in day-day use was logged, as well as user satisfaction, donning/setup times and diary data. This data demonstrated that ShefStim® could be used in the community. Lab-based testing suggested that ShefStim® was comparable to conventional FES systems with regards kinematics at initial contact and foot-clearance. User satisfaction was comparable for both devices. However, further product refinement around setup and the electrode array-skin interface is necessary to make ShefStim® commercially viable. Article 4 reports on the design, development and evaluation of ShefStim®. PART 2 comprises two meta-analyses focussing on orthotic (Article 5) and therapeutic (Article 6) effects. Article 5 revealed statistically comparable positive orthotic effects on walking speed, exercise capacity and the stroke impact scale. Article 6 found comparable therapeutic speed increases, but both reviews highlighted the lack of high quality evidence on use of each device outside of the laboratory. It was not possible draw any conclusions about the mechanisms-of-action underlying these findings. Conclusion and future study The dorsiflex sock and ShefStim® are both feasible devices and the novel approaches taken to their evaluation merit wider use in the field. Further work is necessary to improve the design of both devices before definitive clinical trials are carried out. Despite AFO and FES showing similar levels of efficacy there is very little published work on the real world evaluation of either type of device or foot-drop specific mechanistic evaluations that might help to guide clinical choice. Therefore, this thesis highlights the need for further comparative randomised controlled trials, focussing on biomechanical and real world measures, informed by potential end-users

Functional electrical stimulation versus ankle foot orthoses for foot-drop: a meta-analysis of orthotic effects

Objective: To compare the effects on walking of Functional Electrical Stimulation (FES) and Ankle Foot Orthoses (AFO) for foot-drop of central neurological origin, assessed in terms of unassisted walking behaviours compared with assisted walking following a period of use (combined-orthotic effects). Data Sources: MEDLINE, AMED, CINAHL, Cochrane Central Register of Controlled Trials, Scopus, REHABDATA, PEDro, NIHR Centre for Reviews and Dissemination and clinicaltrials.gov. plus reference list, journal, author and citation searches. Study Selection: English language comparative Randomised Controlled Trials (RCTs). Data Synthesis: Seven RCTs were eligible for inclusion. Two of these reported different results from the same trial and another two reported results from different follow up periods so were combined; resulting in five synthesised trials with 815 stroke participants. Meta-analyses of data from the final assessment in each study and three overlapping time-points showed comparable improvements in walking speed over ten metres (p=0.04-0.95), functional exercise capacity (p=0.10-0.31), timed up-and-go (p=0.812 and p=0.539) and perceived mobility (p=0.80) for both interventions. Conclusion: Data suggest that, in contrast to assumptions that predict FES superiority, AFOs have equally positive combined-orthotic effects as FES on key walking measures for foot-drop caused by stroke. However, further long-term, high-quality RCTs are required. These should focus on measuring the mechanisms-of-action; whether there is translation of improvements in impairment to function, plus detailed reporting of the devices used across diagnoses. Only then can robust clinical recommendations be made

Functional electrical stimulation and ankle foot orthoses provide equivalent therapeutic effects on foot drop: A meta-analysis providing direction for future research

Objective: To compare the randomized controlled trial evidence for therapeutic effects on walking of functional electrical stimulation and ankle foot orthoses for foot drop caused by central nervous system conditions. Data sources: MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, REHABDATA, PEDro, NIHR Centre for Reviews and Dissemination, Scopus and clinicaltrials.gov. Study selection: One reviewer screened titles/abstracts. Two independent reviewers then screened the full articles. Data extraction: One reviewer extracted data, another screened for accuracy. Risk of bias was assessed by 2 independent reviewers using the Cochrane Risk of Bias Tool. Data synthesis: Eight papers were eligible; 7 involving participants with stroke and 1 involving participants with cerebral palsy. Two papes reporting different measures from the same trial were grouped, resulting in 7 synthesized randomized controlled trials (n= 464). Meta-analysis of walking speed at final assessment (p = 0.46), for stroke participants (p = 0.54) and after 4–6 weeks’ use (p = 0.49) showed equal improvement for both devices. Conclusion: Functional electrical stimulation and ankle foot orthoses have an equally positive therapeutic effect on walking speed in non-progressive central nervous system diagnoses. The current randomized controlled trial evidence base does not show whether this improvement translates into the user’s own environment or reveal the mechanisms that achieve that change. Future studies should focus on measuring activity, muscle activity and gait kinematics. They should also report specific device details, capture sustained therapeutic effects and involve a variety of central nervous system diagnoses

The design, development and evaluation of an array-based FES system with automated setup for the correction of drop foot

Functional electrical stimulation has been shown to be a safe and effective means of correcting drop foot of central neurological origin. However, despite recent technological advances, the set-up of surface stimulators remains a challenge for many users with drop foot. The automation of the setup process through the use of electrode arrays has been proposed as a way to address this problem. This paper describes a series of research and clinical studies which have led to the first demonstration of unsupervised automated setup of an electrode-array based drop foot stimulator. Finally, future research plans are discussed

A review of the design and clinical evaluation of the ShefStim array-based functional electrical stimulation system

Functional electrical stimulation has been shown to be a safe and effective means of correcting foot 12 drop of central neurological origin. Current surface-based devices typically consist of a single channel stimulator, 13 a sensor for determining gait phase and a cuff, within which is housed the anode and cathode. The cuff-mounted 14 electrode design reduces the likelihood of large errors in electrode placement, but the user is still fully responsible 15 for selecting the correct stimulation level each time the system is donned. Researchers have investigated different 16 approaches to automating aspects of setup and/or use, including recent promising work based on iterative learning 17 techniques. This paper reports on the design and clinical evaluation of an electrode array-based FES system for 18 the correction of drop foot, ShefStim. The paper reviews the design process from proof of concept lab-based study, 19 through modelling of the array geometry and interface layer to array search algorithm development. Finally, the 20 paper summarises two clinical studies involving patients with drop foot. The results suggest that the ShefStim 21 system with automated setup produces results which are comparable with clinician setup of conventional systems. 22 Further, the final study demonstrated that patients can use the system without clinical supervision. When used 23 unsupervised, setup time was 14 minutes (9 minutes for automated search plus 5 minutes for donning the 24 equipment), although this figure could be reduced significantly with relatively minor changes to the design

Caregiver delivered sensory electrical stimulation for post stroke upper limb spasticity: A single blind crossover randomized feasibility study

We developed a 64 channel sensory electrical stimulator which delivers a dynamic and variable ‘Sensory Barrage’ Stimulation (SBS). Our aim was to assess the feasibility of caregivers delivering the stimulation in the community for a clinical trial comparing single channel Transcutaneous Electrical Nerve Stimulation (TENS) with SBS for post stroke upper limb spasticity. We trained caregivers of 16 participants with post stroke upper limb spasticity to sequentially administer SBS and TENS for 60 min daily for four weeks each, with a washout period of two weeks in between. Outcome measures tested were recruitment and retention rates, compliance with interventions and daily recording of Participant -reported Numerical Rating Scale (NRS). We also collected results of Action Research Arm Test (ARAT), Leeds Arm Spasticity Impact Scale (LASIS) and Modified Ashworth Scale (MAS) for spasticity. Out of 21 potential participants, 16 consented and 15 completed the protocol. Ten participants received TENS for 80% (23/28) of the intended hours. Eleven participants completed NRS for at 80% (45/56) of the study days. All participants attended all visits. The MAS reduced by at least one in five participants after SBS and in three after TENS. Minimal Clinically Important Difference (MCID) of four points increase in ARAT was seen in five participants following TENS, and in four following SBS. A MCID of 18% decrease in NRS was reported by eight participants after TENS and three after SBS. This study demonstrated the feasibility of undertaking a trial of sensory electrical stimulation for post-stroke spasticity with caregivers delivering intervention in community. The study was not powered to detect efficacy of the interventions. Trial registration number: NCT02907775.Date 20-9-2016

Improving the quality of primary teaching in a developing country: an analytical evaluation of an in-service training programme in Sindh Province, Pakistan

The province of Sindh, Pakistan has had considerable donor investment in its primary education system through development projects since the 1960s. These have not made an observable impact on the quality of  teaching in government primary schools. This research is an evaluation and study of a pilot in-service teacher training programme, a component of the Sindh Primary Education Development Programme (1991 - 96). At the  heart of the research is the question "How is it possible to effect long-term, sustainable change and  development in schools in order to make teaching more effective?"Two basic hypotheses were considered during the course of the programme:(I) In-service training courses alone are not effective in changing teachers' behaviour and improving the quality of teaching beyond the short-term. School based developmental work should be integrated with the training  plan, to initiate and sustain change and improvement. (ii) In the context of this programme, supervisors and primary headteachers are the most appropriate persons  to conduct in-service training as they can continue to support and sustain development within schools. There is  evidence to support both these hypotheses. The research indicates that the training has led to changes in  perceptions, attitudes and understanding as well as in supervision, management and classroom practice but  that the greatest change has been where follow-up support was given. There is evidence that,  where a collaborative culture exists within a school, successful innovation is more likely to occur. Community  involvement has also been found to be an important element in school development. The thesis concludes that there are limits to the amount of change possible without extra resources and direct  support in schools. Training programmes should support networking and development within localities rather  than train teachers in isolation from the context in which they work.Subsequently, a postscript has been added to the thesis. This is a reflective critical analysis of the development  of the author's thinking over the period of the research with regard to a number of philosophical, epistemological  and strategic issues relating to methodology and the dynamics of change