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

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

Enhancing public involvement in assistive technology design research

Purpose: To appraise the application of accepted good practice guidance on public involvement in assistive technology research and to identify its impact on the research team, the public, device and trial design. Methods: Critical reflection and within-project evaluation were undertaken in a case study of the development of a functional electrical stimulation device. Individual and group interviews were undertaken with lay members of a 10 strong study user advisory group and also research team members. Results: Public involvement was seen positively by research team members, who reported a positive impact on device and study designs. The public identified positive impact on confidence, skills, self-esteem, enjoyment, contribution to improving the care of others and opportunities for further involvement in research. A negative impact concerned the challenge of engaging the public in dissemination after the study end. Conclusions: The public were able to impact significantly on the design of an assistive technology device which was made more fit for purpose. Research team attitudes to public involvement were more positive after having witnessed its potential first hand. Within-project evaluation underpins this case study which presents a much needed detailed account of public involvement in assistive technology design research to add to the existing weak evidence base.Implications for Rehabilitation • The evidence base for impact of public involvement in rehabilitation technology design is in need of development. • Public involvement in co-design of rehabilitation devices can lead to technologies that are fit for purpose. • Rehabilitation researchers need to consider the merits of active public involvement in research.</p