Clinical and biomechanical effectiveness of foot-ankle exercise programs and weight-bearing activity in people with diabetes and neuropathy: A systematic review and meta-analysis.

BACKGROUND: Most interventions to prevent foot ulcers in people with diabetes do not seek to reverse the foot abnormalities that led to the ulcer. Foot-ankle exercise programs target these clinical and biomechanical factors, such as protective sensation and mechanical stress. Multiple RCTs exist investigating the effectiveness of such programs, but these have never been summarised in a systematic review and meta-analysis. METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on foot-ankle exercise programs for people with diabetes at risk of foot ulceration. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed the risk of bias of controlled studies and extracted data. Meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was performed when >2 RCTs were available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: We included a total of 29 studies, of which 16 were RCTs. A foot-ankle exercise programme of 8-12 weeks duration for people at risk of foot ulceration results in: (a) no increase or decrease risk of foot ulceration or pre-ulcerative lesion (Risk Ratio (RR): 0.56 (95% CI: 0.20-1.57)); (b) no increase or decrease risk of adverse events (RR: 1.04 (95% CI: 0.65-1.67)); (c) not increase or decrease barefoot peak plantar pressure during walking (Mean Difference (MD): -6.28 kPa (95% CI: -69.90-57.34)); (d) no increase or decrease health-related quality of life (no meta-analysis possible). Likely results in increases in ankle joint and first metatarsalphalangeal joint range of motion (MD: 1.49° (95% CI: -0.28-3.26)) may result in improvements in neuropathy signs and symptoms (MD: -1.42 (95% CI: -2.95-0.12)), may result in a small increase in daily steps in some people (MD: 131 steps (95% CI: -492-754)), and may not increase or decrease foot and ankle muscle strength and function (no meta-analysis was possible). CONCLUSIONS: In people at risk of foot ulceration, a foot-ankle exercise programme of 8-12 weeks duration may not prevent or cause diabetes-related foot ulceration. However, such a programme likely improves the ankle joint and first metatarsalphalangeal joint range of motion and neuropathy signs and symptoms. Further research is needed to strengthen the evidence base, and should also focus on the effects of specific components of foot-ankle exercise programs.

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis.

AIMS: Prevention of foot ulcers in persons with diabetes is important to help reduce the substantial burden on both individual and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review and meta-analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at risk thereof. MATERIALS AND METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on preventative interventions. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed risk of bias of controlled studies and extracted data. A meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was done when >1 RCT was available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: From the 19,349 records screened, 40 controlled studies (of which 33 were Randomised Controlled Trials [RCTs]) and 103 non-controlled studies were included. We found moderate certainty evidence that temperature monitoring (5 RCTs; risk ratio [RR]: 0.51; 95% CI: 0.31-0.84) and pressure-optimised therapeutic footwear or insoles (2 RCTs; RR: 0.62; 95% CI: 0.26-1.47) likely reduce the risk of plantar foot ulcer recurrence in people with diabetes at high risk. Further, we found low certainty evidence that structured education (5 RCTs; RR: 0.66; 95% CI: 0.37-1.19), therapeutic footwear (3 RCTs; RR: 0.53; 95% CI: 0.24-1.17), flexor tenotomy (1 RCT, 7 non-controlled studies, no meta-analysis), and integrated care (3 RCTs; RR: 0.78; 95% CI: 0.58-1.06) may reduce the risk of foot ulceration in people with diabetes at risk for foot ulceration. CONCLUSIONS: Various interventions for persons with diabetes at risk for foot ulceration with evidence of effectiveness are available, including temperature monitoring (pressure-optimised) therapeutic footwear, structured education, flexor tenotomy, and integrated foot care. With hardly any new intervention studies published in recent years, more effort to produce high-quality RCTs is urgently needed to further improve the evidence base. This is especially relevant for educational and psychological interventions, for integrated care approaches for persons at high risk of ulceration, and for interventions specifically targeting persons at low-to-moderate risk of ulceration.

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update).

AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals. MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability. RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration. CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.

The Care and Management of Children and Young People with Ataxia Telangiectasia Provided by Nurses and Allied Health Professionals: a Scoping Review.

Ataxia telangiectasia (A-T) is a rare, multisystem progressive condition that typically presents in early childhood. In the absence of cure, people with A-T require coordinated multidisciplinary care to manage their complex array of needs and to minimize the disease burden. Although symptom management has proven benefits for this population, including improved quality of life and reduced complications, there is a need for guidance specific to the nursing and allied healthcare teams who provide care within the community. A scoping review, adopting the Joanna Briggs Institute methodology, was undertaken. It aimed to identify and map the available expertise from nursing and allied healthcare and management of children and young people with A-T ≤ 18 years of age. A rigorous search strategy was employed which generated a total of 21,118 sources of evidence, of which 50 were selected for review following screening by experts. A range of interventions were identified that reported a positive impact on A-T-related impairments, together with quality of life, indicating that outcomes can be improved for this population. Most notable interventions specific to A-T include therapeutic exercise, inspiratory muscle training, and early nutritional assessment and intervention. Further research will be required to determine the full potential of the identified interventions, including translatability to the A-T setting for evidence related to other forms of ataxia. Large gaps exist in the nursing and allied health evidence-base, highlighting a need for robust research that includes children and young people with A-T and their families to better inform and optimize management strategies.

Systematic review and meta-analysis of the effects of foot and ankle physical therapy, including mobilisations and exercises, in people with diabetic peripheral neuropathy on range of motion, peak plantar pressures and balance.

To evaluate the effects of foot and ankle physical therapy on ankle and first metatarsophalangeal joint range of motion (ROM), peak plantar pressures (PPPs) and balance in people with diabetes. MEDLINE, EBSCO, Cochrane Database of Systematic Reviews, Joanna Briggs Institute Database of Systematic Reviews, PROSPERO, EThOS, Web of Science and Google Scholar were searched in April 2022. Randomised Controlled Trials (RCT), quasi-experimental, pre-post experimental design and prospective cohort studies were included. Participants were people with diabetes, neuropathy and joint stiffness. Interventions included physical therapy such as mobilisations, ROM exercises and stretches. Outcome measures focused on ROM, PPPs and balance. Methodological quality was assessed with Critical Appraisal Skills Programme RCT and Risk-of-Bias 2 tool. Meta-analyses used random-effects models and data was analysed using the inverse variance method. In total, 9 studies were included. Across all studies, participant characteristics were similar; however, type and exercise dosage varied greatly. Meta-analysis was performed with four studies. Meta-analysis showed significant effects of combined exercise interventions in increasing total ankle ROM (3 studies: MD, 1.76; 95% CI, 0.78-2.74; p = 0; I2  = 0%); and reducing PPPs in the forefoot area (3 studies; MD, -23.34; 95% CI, -59.80 to 13.13; p = 0.21, I2  = 51%). Combined exercise interventions can increase ROM in the ankle and reduce PPPs in the forefoot. Standardisation of exercise programmes with or without the addition of mobilisations in the foot and ankle joints needs further research.

The effects of wearing textured versus smooth shoe insoles for 4-weeks in people with diabetic peripheral neuropathy: a randomised controlled trial.

PURPOSE: To determine whether short-term wear of textured insoles alters balance, gait, foot sensation, physical activity, or patient-reported outcomes, in people with diabetic neuropathy. MATERIALS AND METHODS: 53 adults with diabetic neuropathy were randomised to wear textured or smooth insoles for 4-weeks. At baseline and post-intervention, balance (foam/firm surface; eyes open/closed) and walking were assessed whilst barefoot, wearing shoes only, and two insoles (textured/smooth). The primary outcome was center of pressure (CoP) total sway velocity. Secondary outcomes included other CoP measures, spatiotemporal gait measures, foot sensation, physical activity, and patient-reported outcomes (foot health, falls efficacy). RESULTS: Wearing textured insoles led to improvements in CoP measures when standing on foam with eyes open, relative to smooth insoles (p ≤ 0.04). The intervention group demonstrated a 5% reduction in total sway velocity, indicative of greater balance. The intervention group also showed a 9-point improvement in self-perceived vigour (p = 0.03). Adjustments for multiple comparisons were not applied. CONCLUSIONS: This study provides weak statistical evidence in favour of textured insoles. Wearing textured insoles may alter measures of balance, suggestive of greater stability, in people with diabetic neuropathy. Plantar stimulation, through textured insoles, may have the capacity to modulate the perception of foot pain, leading to improved well-being.IMPLICATIONS FOR REHABILITATIONShort-term wear of textured insoles can lead to improvements in centre of pressure sway measures when standing on a compliant supporting surface.Wearing textured insoles may have the capacity to help relieve foot pain leading to enhanced self-perceived vitality in people with diabetic peripheral neuropathy.

Off-loading and compression therapy strategies to treat diabetic foot ulcers complicated by lower limb oedema: a scoping review.

BACKGROUND: Lower limb oedema is a common co-morbidity in those with diabetes and foot ulceration and is linked with increased amputation risk. There is no current guidance for the treatment of concurrent diabetic foot ulcers and lower limb oedema, leading to uncertainty around the safety and efficacy of combination approaches incorporating offloading and compression therapies. To determine indications and contraindications for such strategies and identify any other supplementary treatment approaches, a scoping review was undertaken to map the evidence relating to off-loading and compression therapy strategies to treat both diabetic foot ulcers and lower limb oedema in combination. METHODS: Following the Joanna Briggs Institute (JBI) and PRISMA - Scoping Review (ScR) guidance, this review included published and unpublished literature from inception to April 2022. Literature was sourced using electronic databases including Cochrane Library, PubMed, CINAHL, AMED; websites; professional journals and reference lists of included literature. Eligible literature discussed the management of both diabetic foot ulceration and lower limb oedema and included at least one of the treatment strategies of interest. Data extraction involved recording any suggested off-loading, compression therapy or supplementary treatment strategies and any suggested indications, contraindications and cautions for their use. RESULTS: Five hundred twenty-two publications were found relating to the management of diabetic foot ulcers with an off-loading strategy or the management of lower limb oedema with compression therapy. 51 publications were eligible for inclusion in the review. The majority of the excluded publications did not discuss the situation where diabetic foot ulceration and lower limb oedema present concurrently. CONCLUSIONS: Most literature, focused on oedema management with compression therapy to conclude that compression therapy should be avoided in the presence of severe peripheral arterial disease. Less literature was found regarding off-loading strategies, but it was recommended that knee-high devices should be used with caution when off-loading diabetic foot ulcers in those with lower limb oedema. Treatment options to manage both conditions concurrently was identified as a research gap. Integrated working between specialist healthcare teams, was the supplementary strategy most frequently recommended. In the absence of a definitive treatment solution, clinicians are encouraged to use clinical reasoning along with support from specialist peers to establish the best, individualised treatment approach for their patients. TRIAL REGISTRATION: Open Science Framework (osf.io/crb78).

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study.

BACKGROUND: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimising plantar foot pressure reduction in people with diabetes has been developed. AIM: To explore the feasibility and acceptability of testing an optimised insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy. METHODS: A double-blinded multi-centre feasibility RCT with an embedded qualitative study. Participants were randomised to either an optimised insole group (intervention) or a standard cushioned insole group (active control). Participants were assessed at baseline, 3, 6, and 12 months with clinical outcomes of foot ulceration and mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analysed using descriptive statistics (quantitative data) and thematic analysis (qualitative data). RESULTS: Screened were142 patients from which 61 were recruited; 30 participants were randomised to the intervention group and 31 to the active control group. Forty-two participants completed the study. At 12 months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. There were 17 incidences of foot ulceration occurring in 7/31 of the active control group and 10/30 in the intervention group. Mean difference in MPPP between the intervention and active control groups for all regions-of-interest combined favoured the intervention. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. CONCLUSION: The results of the feasibility RCT suggest that the optimised insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN16011830 . Registered 9th October 2017.

Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT.

INTRODUCTION: People with diabetic peripheral neuropathy (DPN) and limited joint mobility syndrome (LJMS) can experience increased forefoot peak plantar pressures (PPPs), a known risk factor for ulceration. The aim of this study was to investigate whether ankle and 1st metatarsophalangeal (MTP) joint mobilisations and home-based stretches in people with DPN improve joint range of motion (ROM) and reduce forefoot PPPs. DESIGN AND METHODS: Sixty-one people with DPN (IWGDF risk 2), were randomly assigned to a 6-week programme of ankle and 1st MTP joint mobilisations (n = 31) and home-based stretches or standard care only (n = 30). At baseline (T0); 6-week post intervention (T1) and at 3 months follow-up (T2), a blinded assessor recorded dynamic ankle dorsiflexion range using 3D (Codamotion) motion analysis and the weight bearing lunge test, static 1st MTP joint dorsiflexion ROM, dynamic plantar pressure and balance. RESULTS: At T1 and T2 there was no difference between both groups in ankle dorsiflexion in stance phase, plantar pressure and balance. Compared to the control group, the intervention group showed a statistically significant increase in static ankle dorsiflexion range (Left 1.52 cm and 2.9cms, Right 1.62 cm and 2.7 cm) at 6 (T1) and 18 weeks (T2) respectively p < 0.01). Between group differences were also seen in left hallux dorsiflexion (2.75°, p < 0.05) at T1 and in right hallux dorsiflexion ROM (4.9°, p < 0.01) at T2 follow up. Further, functional reach showed a significant increase in the intervention group (T1 = 3.13 cm p < 0.05 and T2 = 3.9 cm p < 0.01). Intervention adherence was high (80%). CONCLUSIONS: Combining ankle and 1st MTP joint mobilisations with home-based stretches in a 6-week programme in people with DPN is effective in increasing static measures of range. This intervention may be useful for improving ankle, hallux joint mobility and anteroposterior stability limits in people with diabetes and neuropathy but not for reducing PPP or foot ulcer risk. TRIAL REGISTRATION: https://classic. CLINICALTRIALS: gov/ct2/show/NCT03195855 .

Prevalence and incidence of mental health issues amongst adults with diabetes at risk of foot complications in the European Union: a systematic review protocol.

OBJECTIVE: The objective of this systematic review is to evaluate and synthesize the evidence to establish the prevalence and incidence of mental health issues in people at risk of diabetic foot ulceration living within the European Union. INTRODUCTION: Due to the large health and financial burden of diabetic foot ulceration, prevention is a key focus for clinicians and researchers. Current foot ulcer prevention strategies are directed at the assessment and management of physical pathologies and risk factors for diabetic foot ulceration. Psychological burden and risk factors are often overlooked. This review will determine the prevalence and incidence of mental health issues among adults with diabetes mellitus who are at risk of foot ulceration. The review will focus on European Union countries. INCLUSION CRITERIA: Studies considered for inclusion will report on adults with a formal diagnosis of either type 1 or type 2 diabetes mellitus, who are at risk of foot ulceration and mental health issues. Studies will have been completed in the European Union. METHODS: A search of MEDLINE, CINAHL, AMED, Embase, Cochrane CENTRAL, and PsycINFO will be conducted for studies published in or translatable into English. Unpublished and gray literature will be searched. Studies will be selected against the review inclusion/exclusion criteria, and selected studies will be critically appraised, with data extraction and synthesis completed using the relevant JBI systematic review tools. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021260815.

Experiences of foot and ankle mobilisations combined with home stretches in people with diabetes: a qualitative study embedded in a proof-of-concept randomised controlled trial.

BACKGROUND: The benefits of exercise and staying active are widely reported in the literature, however adherence and engagement with exercise amongst people with long-term illness and diabetes is poor. Physiotherapy aims to promote independence and physical activity using a range of strategies, including manual therapy and education/advice on exercises. However, low adherence impacts negatively on treatment outcomes. In this study, the practicality of physiotherapy interventions in patients who participate in a proof-of-concept (PoC) randomised controlled trial (RCT) will be considered. AIM: To explore the experiences of people with diabetes who received an intervention package of foot and ankle mobilisations combined with home stretches for a 6-week period. DESIGN: An embedded qualitative study in a proof-of-concept RCT using semi-structured interviews and thematic analysis. PARTICIPANTS: Purposive sample of 16 participants (mean age 73 years) with a diagnosis of diabetes (mean duration 13.4 years) were recruited. RESULTS: Analysis revealed seven themes informing the adherence and non-adherence to the exercise intervention. Themes describing the positive experiences were: 1) support from others to do the exercises; 2) psychological factors to motivate exercise adherence; 2) physical factors contributing to exercise adherence; 4) acceptability of home exercises during and beyond the study. Other themes described barriers: 5) social factors that contributed to exercise disengagement; 6) emotional limitations that influence exercise avoidance; 7) physical circumstances that made exercise participation burdensome. Themes highlighted positive influences by physiotherapists, the motivation of doing exercises while participating in a study, improving the perceived range of motion in their foot and ankle and reducing discomfort in these joints whilst being more active with daily activities. CONCLUSION: Our findings highlighted that the intervention of foot and ankle mobilisations combined with home stretches is feasible for study participants. Psycho-social support, self-efficacy, and physiotherapy support are motivational to adhere to the study intervention and might contribute to the success of a full-scale RCT.

Footwear and insole design features for offloading the diabetic at risk foot-A systematic review and meta-analyses.

The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration in people with diabetic peripheral neuropathy. We searched multiple databases for published and unpublished studies reporting offloading footwear and insoles for people with diabetic neuropathy and nonulcerated feet. Primary outcome was foot ulcer incidence; other outcome measures considered were any standardized kinetic or kinematic measure indicating loading or offloading the plantar foot. Fifty-four studies, including randomized controlled studies, cohort studies, case-series, and a case-controlled and cross-sectional study were included. Three meta-analyses were conducted and random-effects modelling found peak plantar pressure reduction of arch profile (37 kPa (MD, -37.5; 95% CI, -72.29 to -3.61; P < .03), metatarsal addition (35.96 kPa (MD, -35.96; 95% CI, -57.33 to -14.60; P < .001) and pressure informed design 75.4 kPa (MD, -75.4 kPa; 95% CI, -127.4 to -23.44 kPa; P < .004).The remaining data were presented in a narrative form due to heterogeneity. This review highlights the difficulty in differentiating the effect of different insole and footwear features in offloading the neuropathic diabetic foot. However, arch profiles, metatarsal additions and apertures are effective in reducing plantar pressure. The use of pressure analysis to enhance the effectiveness of the design of footwear and insoles, particularly through modification, is recommended.

Behaviour change approaches for individuals with diabetes to improve foot self-management: a scoping review.

BACKGROUND: Diabetes related foot complications are increasing in complexity, frequency and cost. The application of self-management strategies can reduce the risk of individuals developing foot complications. The type, range and nature of the literature focusing on interventions that support patients with diabetic foot self-management is unknown. This scoping review aimed to i) identify self-management actions and risky behaviour avoidance strategies within interventions, ii) map the theoretical functions through which these behaviour change interventions have an effect, iii) display gaps in the research. METHODOLOGY: Arksey and Malley's (2003) 5 stage framework was followed to conduct the scoping study. This methodological framework was selected because it was developed specifically for scoping reviews and therefore offered clear methodological distinction from systematic review methodology. . Databases were searched from inception of the project until June 2020 supplemented by hand searching of reference lists. In total 988 papers were identified. These were independently screened by three reviewers, identifying 19 eligible papers. Data extraction and charting of data was independently conducted by three reviewers to identify study characteristics, self-management actions and risky behaviours. Data was charted against the COM-B (capability, opportunity, motivation, behaviour) model of behaviour to determine intervention function. RESULTS: In total 25 different foot self-management actions and risk behaviours were classified into three themes; routine self-management, trauma avoidance and warning signs and actions. Inspect feet daily received the most attention. The majority of interventions focused on knowledge and skills, but overlooked taking action and decision making. Intervention mapping identified four primary intervention functions (education, persuasion, training and enablement) used to address deficits in capability, opportunity and motivation that positively improved foot self-management behaviour. No studies targeted first ulcer prevention, and most either did not measure or improve foot health outcomes. CONCLUSION: This review charted the evidence for interventions promoting diabetic foot self-management through a theoretical behaviour change perspective. A core set of behaviour change activities and intervention functions associated with positive changes in behaviour were identified. This information will provide researchers with a useful basis for developing self-management interventions.

The prevalence, distribution, and functional importance of lower limb somatosensory impairments in chronic stroke survivors: a cross sectional observational study.

Purpose: To investigate the prevalence and distribution of lower limb somatosensory impairments in community dwelling chronic stroke survivors and examine the association between somatosensory impairments and walking, balance, and falls. Methods: Using a cross sectional observational design, measures of somatosensation (Erasmus MC modifications to the (revised) Nottingham Sensory Assessment), walking ability (10 m walk test, Walking Impact Scale, Timed "Get up and go"), balance (Functional Reach Test and Centre of Force velocity), and falls (reported incidence and Falls Efficacy Scale-International), were obtained. Results: Complete somatosensory data was obtained for 163 ambulatory chronic stroke survivors with a mean (SD) age 67(12) years and mean (SD) time since stroke 29 (46) months. Overall, 56% (n = 92/163) were impaired in the most affected lower limb in one or more sensory modality; 18% (n = 30/163) had impairment of exteroceptive sensation (light touch, pressure, and pin-prick), 55% (n = 90/163) had impairment of sharp-blunt discrimination, and 19% (n = 31/163) proprioceptive impairment. Distal regions of toes and foot were more frequently impaired than proximal regions (shin and thigh). Distal proprioception was significantly correlated with falls incidence (r = 0.25; p < 0.01), and centre of force velocity (r = 0.22, p < 0.01). The Walking Impact Scale was the only variable that significantly contributed to a predictive model of falls accounting for 15-20% of the variance. Conclusion: Lower limb somatosensory impairments are present in the majority of chronic stroke survivors and differ widely across modalities. Deficits of foot and ankle proprioception are most strongly associated with, but not predictive, of reported falls. The relative contribution of lower limb somatosensory impairments to mobility in chronic stroke survivors appears limited. Further investigation, particularly with regard to community mobility and falls, is warranted. Implications for Rehabilitation Somatosensory impairments in the lower limb were present in approximately half of this cohort of chronic stroke survivors. Tactile discrimination is commonly impaired; clinicians should include an assessment of discriminative ability. Deficits of foot and ankle proprioception are most strongly associated with reported falls. Understanding post-stroke lower limb somatosensory impairments may help inform therapeutic strategies that aim to maximise long-term participation, minimise disability, and reduce falls.

Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial.

INTRODUCTION: Peripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations. This study aims to explore whether wearing textured insoles for 4 weeks alters balance performance in adults with diabetic peripheral neuropathy. METHODS AND ANALYSIS: A prospective, single-blinded randomised controlled trial with parallel groups will be conducted on 70 adults with diabetic peripheral neuropathy. Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20 m (with/without an assistive device), will be recruited. Participants will be randomised to receive a textured insole (n=35) or smooth insole (n=35), to be worn for 4 weeks. During baseline and post intervention assessments, standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured). The primary outcome measure will be centre of pressure (CoP) velocity, with higher values indicating poorer balance. Secondary outcome measures include walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion). Patient-reported outcomes will be completed evaluating foot health, frequency of falls and fear of falling. Data will be analysed using a repeated measures mixed models approach (including covariates) to establish any differences between-groups, for all outcome measures, over the intervention period. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the institutional Human Research Ethics Committee (#2017000098). Findings will be disseminated at national and international conferences, through peer-reviewed journals, workshops and social media. TRIAL REGISTRATION NUMBER: ACTRN12617000543381; Pre-results.

INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol.

INTRODUCTION: Foot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration. AIM: This study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy. METHODS AND ANALYSIS: This study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention. ETHICS AND DISSEMINATION: The study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications. TRIALS REGISTRATION NUMBER: ISRCTN16011830; Pre-results.

The physical characteristics of materials used in the manufacture of orthoses for patients with diabetes.

BACKGROUND: Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues can be modified. Orthotic therapy is one practical method commonly used to maintain tissue integrity. Orthotic design must consider the materials chosen for use in fabrication and profile of the device because both aspects influence the performance and durability of the device. Published research evaluating the physical properties of materials commonly used in the manufacture of orthoses for patients with diabetes is limited. This study investigated the physical properties of materials used to fabricate orthoses designed for the prevention of neuropathic diabetic foot ulcers. METHODS: Fifteen commonly used orthotic materials were selected for testing: four specifications of 6.4-mm Poron (Rogers Corp., Gent, Belgium), 3.2-mm Poron, three densities of 12-mm Ethylene Vinyl Acetate (EVA), 12-mm low-density plastazote, two depths (6.4-mm, 3.2-mm) of Cleron (Algeo Ltd., Liverpool, UK), Professional Protective Technology (PPT), and MaxaCane (Algeo Ltd, Liverpool, UK). The density, resilience, stiffness, static coefficient of friction, durability, and compression set of each material were tested, ranked, and allocated a performance indicator score. RESULTS: The most clinically desirable dampening materials tested were Poron 96 (6-mm) and Poron 4000 (6-mm). High density EVA (Algeo Ltd., Liverpool, UK) and Lunacell Nora EVA (Freudenberg, Weinhein, Germany) possessed the properties most suitable to achieve motion control. The data present a simple and useful comparison and classification of the selected materials. CONCLUSIONS: Although this information should not be used as a single indicator for assessing the suitability of an orthotic material, the results provide clinically relevant information relating to the physical properties of orthotic materials commonly used in the prevention of neuropathic diabetic foot ulcers.

Footwear and insole design features to prevent foot ulceration in people with diabetes: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The aim of this systematic review is to identify the key design features of footwear and insoles that are used to offload the plantar surface of the foot to prevent foot ulceration in adults with diabetes.More specifically, the objectives are to identify the key design features of footwear and insoles to offload the plantar surface of the foot with regard to.

The relationship between navicular drop and first metatarsophalangeal joint motion.

This study was conducted to determine whether navicular drop, as a representative measure of foot pronation, was associated with first metatarsal joint motion in 24 healthy subjects aged 21 to 40 years. The magnitude of first metatarsophalangeal joint motion was identified using a custom-built weightbearing goniometer designed to measure maximal hallux dorsiflexion in stance. The weightbearing measure of navicular drop was recorded using an adapted digital caliper. Statistical analysis demonstrated a significant negative correlation (P < .05) between the two variables. Furthermore, simple regression analysis suggested that 33.2% of the variation in maximal hallux dorsiflexion could be explained by different navicular drop values.

Effect of extrinsic rearfoot post design on the lateral-to-medial position and velocity of the center of pressure.

Findings from investigations of the effects of external forefoot and rearfoot posts added to foot orthoses have been inconclusive. This study was undertaken to examine the effects of rearfoot post design on the lateral-to-medial position and velocity of the center-of-pressure path. Four identical pairs of neutral-cast polypropylene orthotic shells were constructed; three pairs had a rearfoot post of specified design added. The fourth pair, the control, did not have a post added. Stance period data were broken down into four functional phases, and the statistically significant differences between the experimental conditions were calculated and analyzed. The addition of a rearfoot post to an orthotic shell affects center-of-pressure lateral-to-medial position and velocity. Although the effect of the post designs seemed to provide reasonably predictable changes in center-of-pressure position, the effect on center-of-pressure velocity was variable and inconsistent. The effect of the orthotic post was dependent on design and phase of gait. The addition of a rearfoot post and, specifically, the design of the post can probably be used to alter the center-of-pressure position and velocity.