An observational study to assess validity and reliability of smartphone sensor-based gait and balance assessments in multiple sclerosis: Floodlight GaitLab protocol.

Background: Gait and balance impairments are often present in people with multiple sclerosis (PwMS) and have a significant impact on quality of life and independence. Gold-standard quantitative tools for assessing gait and balance such as motion capture systems and force plates usually require complex technical setups. Wearable sensors, including those integrated into smartphones, offer a more frequent, convenient, and minimally burdensome assessment of functional disability in a home environment. We developed a novel smartphone sensor-based application (Floodlight) that is being used in multiple research and clinical contexts, but a complete validation of this technology is still lacking. Methods: This protocol describes an observational study designed to evaluate the analytical and clinical validity of Floodlight gait and balance tests. Approximately 100 PwMS and 35 healthy controls will perform multiple gait and balance tasks in both laboratory-based and real-world environments in order to explore the following properties: (a) concurrent validity of the Floodlight gait and balance tests against gold-standard assessments; (b) reliability of Floodlight digital measures derived under different controlled gait and balance conditions, and different on-body sensor locations; (c) ecological validity of the tests; and (d) construct validity compared with clinician- and patient-reported assessments. Conclusions: The Floodlight GaitLab study (ISRCTN15993728) represents a critical step in the technical validation of Floodlight technology to measure gait and balance in PwMS, and will also allow the development of new test designs and algorithms.

The MoXFo initiative - study design: Considerations related to study design and methodology in exercise research for people with multiple sclerosis.

BACKGROUND: Exercise as a subset of physical activity is a cornerstone in the management of multiple sclerosis (MS) based on its pleiotropic effects, but continued progression of the field requires better future designs and methodologies. OBJECTIVES: This paper outlines the work of the 'Study design and methodology' group of the MoXFo (moving exercise research forward) initiative, and addresses critical aspects and future directions when defining the research question of interest, and subsequently, designing the study and exercise intervention in MS patients. METHODS: The work is based on the formation of an international expert panel formed within the MoXFo initiative. We provide a structured and concise synthesis of exercise-specific MS research challenges and considerations when designing randomized controlled trials (RCTs). RESULTS: Challenges and considerations are presented using the Patient population, Intervention, Comparator, Outcomes, Timing, Setting (PICOTS) framework, thereby forming a new and specific MS exercise PICOTS framework. CONCLUSION: We propose that researchers should carefully consider and align all elements of this MS exercise PICOTS framework when developing future research questions and study designs, ultimately improving the quality of new exercise studies in people with MS.

Telerehabilitation for people with physical disabilities and movement impairment: development and evaluation of an online toolkit for practitioners and patients.

PURPOSE: Telerehabilitation has increasingly been used since the COVID-19 pandemic but with limited guidance available on undertaking physical assessments using remote methods. We aimed to provide such guidance by developing a Telerehab Toolkit, an online information and training resource for practitioners, patients, and carers on telerehabilitation for people with physical disabilities and movement impairment. MATERIALS AND METHODS: Development and evaluation of the toolkit were informed by the Knowledge to Action framework and took place iteratively in two phases-knowledge creation and action. Information was collated from various sources including literature review, online survey, service evaluation, and focus group discussions. The toolkit has been evaluated using think-aloud interviews, e-mail and social media feedback from users, and analytics data on user engagement with the website. RESULTS: The Telerehab Toolkit focuses on remote physical assessments, and contains information on technology, digital skills, remote assessment tools, information governance, and safety for telerehabilitation. Resources include top tips from practitioners and patients, how-to guides, checklists, videos, and links to evidence. CONCLUSIONS: The Telerehab Toolkit has been well-received by practitioners, healthcare students, patients, and carers, is being disseminated widely, and is freely available (www.plymouth.ac.uk/research/telerehab). IMPLICATIONS FOR REHABILITATIONTelerehabilitation has been increasingly used since the COVID-19 pandemic, but with limited guidance and training for practitioners on undertaking safe and effective remote physical assessments.The Telerehab Toolkit has been developed iteratively using the Knowledge to Action framework; it is a free online resource for practitioners and patients with specific guidance on telerehabilitation for physical disabilities and movement impairment.It is anticipated that the resource will help to improve the knowledge, skills, and confidence of the current and future rehabilitation workforce.

Telerehabilitation for physical disabilities and movement impairment: A service evaluation in South West England.

RATIONALE, AIMS AND OBJECTIVES: Telerehabilitation was used to ensure continued provision of care during the COVID-19 pandemic, but there was a lack of guidance on how to use it safely and effectively for people with physical disabilities and movement impairment. In this service evaluation, we aimed to collate information on practitioner and patient experiences, challenges and facilitators, and examples of best practice to inform the development of an online toolkit and training package. METHODS: Guided discussions were carried out with 44 practitioners, 7 patients and 2 carers from five health and social care organisations in South West England, and analysed thematically. RESULTS: Practitioners and patients had positive experiences of telerehabilitation and were optimistic about its future use. Recognized benefits for people with physical disabilities included greater flexibility, reduced travel and fatigue, having appointments in a familiar environment and ease of involving family members. Challenges encountered were: technological (usability issues, access to technology and digital skills); difficulties seeing or hearing patients; the lack of 'hands-on' care; and safety concerns. Facilitators were supported by colleagues or digital champions, and family members or carers who could assist patients during their appointments. Key themes in best practice were: person-centred and tailored care; clear and open communication and observation and preparation and planning. Practitioners shared tips for remote physical assessments; for example, making use of patient-reported outcomes, and asking patients to wear bright and contrasting coloured clothing to make it easier to see movement. CONCLUSION: Telerehabilitation holds promise in health and social care, but it is necessary to share good practice to ensure it is safe, effective and accessible. We collated information and recommendations that informed the content of the Telerehab Toolkit (https://www.plymouth.ac.uk/research/telerehab), a practical resource for practitioners, patients and carers, with a focus on remote assessment and management of physical disabilities and movement impairment.

Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis.

OBJECTIVE: The purpose of this systematic review was to investigate whether aerobic training (AT) or resistance training (RT) is most effective in terms of improving lower limb physical function and perceived fatigue in persons with multiple sclerosis (PwMS). DATA SOURCES: Nine databases (MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health, Allied and Complementary Medicine Database, Physiotherapy Evidence Database, SPORTDiscus, PsycINFO, Web of Science, and Scopus) were electronically searched in April 2020. STUDY SELECTION: Included studies were randomized controlled trials (RCTs) involving PwMS attending 1 of 2 exercise interventions: AT or RT. Studies had to include at least 1 objective or self-reported outcome of lower extremity physical function and/or perceived fatigue. DATA EXTRACTION: Data were extracted using a customized spreadsheet, which included detailed information on patient characteristics, interventions, and outcomes. The methodological quality of the included studies was independently assessed by 2 reviewers using the Tool for Assessment of Study Quality for Reporting on Exercise rating scale. DATA SYNTHESIS: Twenty-seven articles reporting data from 22 RCTS (AT=14, RT=8) including 966 PwMS. The 2 modalities were found to be equally effective in terms of improving short walk test (AT: effect size [ES]=0.33 [95% confidence interval (CI), -1.49 to 2.06]; RT: ES=0.27 [95% CI, 0.07-0.47]) and long walk test performance (AT: ES=0.37 [95% CI, -0.04 to 0.78]; RT: ES=0.36 [95% CI, -0.35 to 1.08]), as well as in reducing perceived fatigue (AT: ES=-0.61 [95% CI, -1.10 to -0.11]; RT: ES=-0.41 [95% CI, -0.80 to -0.02]). Findings on other functional mobility tests along with self-reported walking performance were sparse and inconclusive. CONCLUSIONS: AT and RT appear equally highly effective in terms of improving lower extremity physical function and perceived fatigue in PwMS. Clinicians can thus use either modality to target impairments in these outcomes. In a future perspective, head-to-head exercise modality studies are warranted. Future MS exercise studies are further encouraged to adapt a consensus "core battery" of physical function tests to facilitate a detailed comparison of results across modalities.

Real-World Goal Setting and Use of Outcome Measures According to the International Classification of Functioning, Disability and Health: A European Survey of Physical Therapy Practice in Multiple Sclerosis.

Goal setting is a core component of physical therapy in multiple sclerosis (MS). It is unknown whether and to what extent goals are set at different levels of the International Classification of Functioning, Disability and Health (ICF), and whether, and to which, standardized outcome measures are used in real life for evaluation at the different ICF levels. Our aim was to describe the real-world use of goal setting and outcome measures in Europe. An online cross-sectional survey, completed by 212 physical therapists (PTs) specialized in MS from 26 European countries, was conducted. Differences between European regions and relationships between goals and assessments were analyzed. PTs regularly set goals, but did not always apply the Specific, Measurable, Achievable, Realistic, Timed (SMART) criteria. Regions did not differ in the range of activities assessed, but in goals set (e.g., Western and Northern regions set significantly more goals regarding leisure and work) and outcome measures used (e.g., the Berg Balance Scale was more frequently used in Northern regions). Quality of life was not routinely assessed, despite being viewed as an important therapy goal. Discrepancies existed both in goal setting and assessment across European regions. ICF assists in understanding these discrepancies and in guiding improved health-care for the future.

Content and Delivery of Physical Therapy in Multiple Sclerosis across Europe: A Survey.

Background: Guidelines and general recommendations are available for multiple sclerosis rehabilitation, but no specific guidance exists for physical therapists. Describing aspects of physical therapy content and delivery in multiple sclerosis and its determinants and analysing whether general recommendations connected with physical therapy are implemented in practice is important for interpreting clinical and research evidence. Methods: An online cross-sectional survey of physical therapists specialized in multiple sclerosis (212 specialists from 26 European countries) was used. Results: There was distinct diversity in service delivery and content across Europe. Perceived accessibility of physical therapy varied from most accessible in the Western region, and least in the Southern region. Sixty-four physical therapists adjusted their approach according to different disability levels, less so in the Eastern region. Duration, frequency and dose of sessions differed between regions, being highest in Southern and Western regions. "Hands on treatment" was the most commonly used therapeutic approach in all apart from the Northern regions, where "word instruction" (providing advice and information) prevailed. Conclusions: The content and delivery of physical therapy differs across Europe. Recommendations concerning access to treatment and adjustment according to disability do not appear to be widely implemented in clinical practice.

Influence of cardiac autonomic neuropathy on cardiac repolarisation during incremental adrenaline infusion in type 1 diabetes.

AIMS/HYPOTHESIS: We examined the effect of a standardised sympathetic stimulus, incremental adrenaline (epinephrine) infusion on cardiac repolarisation in individuals with type 1 diabetes with normal autonomic function, subclinical autonomic neuropathy and established autonomic neuropathy. METHODS: Ten individuals with normal autonomic function and baroreceptor sensitivity tests (NAF), seven with subclinical autonomic neuropathy (SAN; normal standard autonomic function tests and abnormal baroreceptor sensitivity tests); and five with established cardiac autonomic neuropathy (CAN; abnormal standard autonomic function and baroreceptor tests) underwent an incremental adrenaline infusion. Saline (0.9% NaCl) was infused for the first hour followed by 0.01 µg kg-1 min-1 and 0.03 µg kg-1 min-1 adrenaline for the second and third hours, respectively, and 0.06 µg kg-1 min-1 for the final 30 min. High resolution ECG monitoring for QTc duration, ventricular repolarisation parameters (T wave amplitude, T wave area symmetry ratio) and blood sampling for potassium and catecholamines was performed every 30 min. RESULTS: Baseline heart rate was 68 (95% CI 60, 76) bpm for the NAF group, 73 (59, 87) bpm for the SAN group and 84 (78, 91) bpm for the CAN group. During adrenaline infusion the heart rate increased differently across the groups (p = 0.01). The maximum increase from baseline (95% CI) in the CAN group was 22 (13, 32) bpm compared with 11 (7, 15) bpm in the NAF and 10 (3, 18) bpm in the SAN groups. Baseline QTc was 382 (95% CI 374, 390) ms in the NAF, 378 (363, 393) ms in the SAN and 392 (367, 417) ms in the CAN groups (p = 0.31). QTc in all groups lengthened comparably with adrenaline infusion. The longest QTc was 444 (422, 463) ms (NAF), 422 (402, 437) ms (SAN) and 470 (402, 519) ms (CAN) (p = 0.09). T wave amplitude and T wave symmetry ratio decreased and the maximum decrease occurred earlier, at lower infused adrenaline concentrations in the CAN group compared with NAF and SAN groups. AUC for the symmetry ratio was different across the groups and was lowest in the CAN group (p = 0.04). Plasma adrenaline rose and potassium fell comparably in all groups. CONCLUSIONS/INTERPRETATION: Participants with CAN showed abnormal repolarisation in some measures at lower adrenaline concentrations. This may be due to denervation adrenergic hypersensitivity. Such individuals may be at greater risk of cardiac arrhythmias in response to physiological sympathoadrenal challenges such as stress or hypoglycaemia.

Assessing lower limb position sense in stroke using the gradient discrimination test (GradDT™) and step-height discrimination test (StepDT™): a reliability and validity study.

Purpose: To evaluate the psychometric properties of two novel tests of lower limb position sense.Methods: Our newly developed tests assess the discrimination thresholds of under-foot slope and step height perception using a two alternative forced choice approach. Stroke participants (n = 32) and age matched controls (n = 32) were tested. Inter- and intra-rater reliability and agreement, sensitivity and specificity, discriminant and convergent validity were evaluated.Results: Intra-rater reliability for both variants of the gradient discrimination test was excellent; intraclass correlation coefficients (ICC) =0.91 and 0.89. The step height discrimination test had excellent intra-rater reliability and agreement: ICC =0.95. Inter-rater reliability was also excellent in both tests (ICC= 0.85-0.93). Discriminant validity was demonstrated with significant differences in test performance between stroke and control participants (p < 0.001). Our novel tests did not significantly correlate with the proprioceptive component of the Erasmus modified Nottingham Sensory Assessment. Receiver Operating Characteristic curve analysis indicated both novel tests to have greater sensitivity and specificity than the proprioceptive component of the Erasmus modified Nottingham Sensory Assessment in predicting the presence of self-reported sensory impairments. Functional reach test, 10 meter walk test, centre of pressure measurement and reported falls showed significant and moderate to strong correlations with novel test performance (r = 0.40-0.60); the Erasmus modified Nottingham Sensory Assessment did not.Conclusions: Our novel, functionally oriented tests of lower limb position sense are reliable, valid and feasible for use in an ambulatory chronic stroke and elderly population.Implications for rehabilitationThe GradDT™ and StepDT are two novel tests of lower limb position sense which are reliable and valid in a chronic stroke sample.They offer clinicians and researchers sensitive, accurate and clinically usable measures of lower limb position sense.

Lower Limb Somatosensory Discrimination Is Impaired in People With Parkinson's Disease: Novel Assessment and Associations With Balance, Gait, and Falls.

BACKGROUND: People with Parkinson's disease (PD) have often compromised walking and balance. This may be the result of the impaired lower limb tactile and proprioceptive sensation. Existing clinical measures may not be sufficiently sensitive to uncover these sensory impairments. OBJECTIVE: To determine whether novel measures of lower limb somatosensory discrimination are psychometrically robust and associated with mobility outcomes in people with PD. METHODS: Lower limb somatosensation was assessed on 2 occasions, 3 to 7 days apart, using the following 3 novel tests: gradient discrimination, roughness discrimination, and step height discrimination. Static and dynamic balance (Brief Balance Evaluations Systems Test), falls incidence, falls confidence (Falls Efficacy Scale), and gait (speed and step length) were also obtained. The participants were 27 people with PD and 27 healthy controls. RESULTS: Novel tests showed good to excellent intrarater reliability (intraclass correlation coefficient = 0.72-0.92). Significantly higher gradient and step height discrimination thresholds (P < 0.01) were demonstrated in the participants with PD when compared with the healthy controls, indicating worse position sense at the ankle, knee, and hip. Significant correlations were identified between gradient discrimination and falls incidence (r = 0.55), falls confidence (r = 0.44), and balance (r = 0.63), but not gait (r = 0.21). Step height discrimination was significantly correlated with balance (r = 0.54). Foot roughness discrimination was not significantly different between people with PD and healthy controls and was not significantly correlated with mobility measures (P > .05). CONCLUSION: These novel tests are psychometrically robust and identify impaired lower limb position sense, which was associated with balance and falls in this sample of PD patients. Interventions targeting somatosensory processing in PD may improve aspects of balance and reduce falls risk. Further research is warranted.

Assessing Plantar Sensation in the Foot Using the Foot Roughness Discrimination Test (FoRDT): A Reliability and Validity Study in Stroke.

BACKGROUND: The plantar foot represents a sensory dynamometric map and is essential for balance and gait control. Sensory impairments are common, yet often difficult to quantify in neurological conditions, particularly stroke. A functionally oriented and quantifiable assessment, the Foot Roughness Discrimination Test (FoRDT), was developed to address these shortcomings. OBJECTIVE: To evaluate inter- and intrarater reliability, convergent and discriminant validity of the FoRDT. DESIGN: Test-retest design. SETTING: Hospital outpatient. PARTICIPANTS: Thirty-two people with stroke (mean age 70 years) at least 3 months after stroke, and 32 healthy, age-matched controls (mean age 70). MAIN OUTCOME MEASURES: Roughness discrimination thresholds were quantified utilizing acrylic foot plates, laser cut to produce graded spatial gratings. Stroke participants were tested on three occasions, and by two different raters. Inter- and intrarater reliability and agreement were evaluated with Intraclass Correlation Coefficients and Bland-Altman plots. Convergent validity was evaluated through Spearman rank correlation coefficients (rho) between the FoRDT and the Erasmus modified Nottingham Sensory Assessment (EmNSA). RESULTS: Intra- and interrater reliability and agreement were excellent (ICC =0.86 [95% CI 0.72-0.92] and 0.90 [95% CI 0.76-0.96]). Discriminant validity was demonstrated through significant differences in FoRDT between stroke and control participants (P < .001). Stroke fallers had statistically significant higher FoRDT scores compared with nonfallers (P = .01). Convergent validity was demonstrated through significant and strong correlations (rho) with the Erasmus MC Nottingham Sensory Assessment (r = .69, P < .01). Receiver operator characteristic curve analysis indicated the novel test to have excellent sensitivity and specificity in predicting the presence of self-reported sensory impairments. Functional Reach test significantly correlated with FoRDT (r = .62, P < .01) whereas measures of postural sway and gait speed did not (r = .16-.26, P > .05). CONCLUSIONS: This simple and functionally oriented test of plantar sensation is reliable, valid, and clinically feasible for use in an ambulatory, chronic stroke and older population. It offers clinicians and researchers a sensitive and robust sensory measure and may further support the evaluation of rehabilitation targeting foot sensation. LEVEL OF EVIDENCE: III.

Evaluation of the Multiple Sclerosis Spasticity Scale 88: A Short Report.

BACKGROUND: The Multiple Sclerosis Spasticity Scale 88 (MSSS-88) is designed to capture the patient experience and impact of spasticity, but there is limited evaluation against clinician-rated measures of spasticity. OBJECTIVE: To evaluate the convergent validity and responsiveness of the MSSS-88. DESIGN: Longitudinal study. SETTING: University Laboratory. SUBJECTS: Thirty-four people with multiple sclerosis. METHODS: People with multiple sclerosis (MS; n = 34) completed the self-reported 12-item Multiple Sclerosis Walking Scale, Multiple Sclerosis Spasticity Scale, Barthel Index alongside the clinician-rated Ashworth Scale, and a laboratory-based measure of ankle spasticity. Spasticity measure responsiveness was evaluated in 20 participants at two time points, an average of 8.75 ± 3.8 months apart. RESULTS: In people with MS (mean age 55.1 ± 8.1 years; Expanded Disability Scale range 4.5-7.0), spasticity symptom specific subscales of the MSSS-88 (stiffness and spasms) showed strong and significant correlations with the clinician-rated Ashworth Scale (r = 0.52-0.53; P < .01). Responsiveness of the MSSS-88 was comparable to a laboratory-based measure of ankle spasticity. CONCLUSIONS: Our findings lend additional support to the convergent validity of this measure.

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.

Comprehensive geriatric assessment and decision-making in older men with incurable but manageable (chronic) cancer.

PURPOSE: In older cancer patients, treatment decision-making is often complex. A comprehensive geriatric assessment (CGA) is an established tool used in geriatric medicine to identify unmet need requiring intervention. This study aimed to assess whether using a CGA in older male cancer patients with incurable but manageable disease provides information that would alter a cancer clinician's intended management plan. Acceptability and feasibility were secondary aims. METHODS: Elderly men with incurable but manageable malignancies (advanced prostate cancer and multiple myeloma) who had previously received at least one line of treatment were recruited from hospital outpatient clinics. A CGA was undertaken. Additional parameters measuring pain, fatigue and disease-specific concerns were also recorded, at the recommendation of patient involvement groups. Results were made available to clinicians. Patient and clinician acceptability and changes in subsequent management were recorded. RESULTS: Forty-eight patients completed the study. The median ages were 70.8 years and 74 years for myeloma and prostate respectively. Most identified concerns are related to disease-specific concerns (93%), pain (91%), frailty (57%) and nutrition (52%). Results altered the clinician's oncological management plan in nine cases only. Patients found the format and content of CGA acceptable. CONCLUSIONS: Many unmet needs were identified in this population of elderly men with manageable but non curable cancer which led to supportive care referrals and interventions. The CGA, however, did not result in significant changes in clinical oncology treatment plans for the majority of patients. The application of the CGA and other assessments was viewed positively by participants and can feasibly be undertaken in the outpatient oncology setting.

Physiotherapeutic interventions in multiple sclerosis across Europe: Regions and other factors that matter.

BACKGROUND: A wide variety of interventions exists in physical therapy (PT), but knowledge about their use across different geographical regions is limited. This study investigated the use of PT interventions in people with multiple sclerosis (MS) across Europe. It aimed to determine whether regions differ in applying interventions, and explore whether factors other than regions play a role in their use. METHODS: In an online cross-sectional survey, 212 respondents from 115 European workplaces providing PT services to people with MS representing 26 countries (four European regions) participated. Cluster analysis, Pearson Chi-squared test and a Poisson regression model were used to analyze the data. RESULTS: Thirteen of 45 listed PT interventions were used by more than 75% of centers, while nine interventions were used by less than 25%. For 12 interventions, regions differed markedly in their use. Cluster analysis of centers identified four clusters similar in their intervention use. Cluster assignment did not fully align with regions. While center region was important, center size, number and gender of physical therapists working in the center, and time since qualification also played a role. Cluster analysis exploring the use of the interventions provided the basis for a categorization of PT interventions in line with their primary focus: 1. Physical activity (fitness/endurance/resistance) training; 2. Neuroproprioceptive "facilitation/inhibition"; 3. Motor/skill acquisition (individualized therapy led); 4. Technology based interventions. CONCLUSIONS: To our knowledge this is the first study that has explored this topic in MS. The results broaden our understanding of the different PT interventions used in MS, as well as the context of their use.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

BACKGROUND: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. AIMS: This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. METHODS & PROCEDURES: Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). OUTCOMES & RESULTS: Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. CONCLUSIONS & IMPLICATIONS: The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention.

Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

Objective: Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Materials and Methods: Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. Results: The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Discussion: Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. Conclusion: While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

Cardiac Autonomic Regulation and Repolarization During Acute Experimental Hypoglycemia in Type 2 Diabetes.

Hypoglycemia is associated with increased cardiovascular mortality in trials of intensive therapy in type 2 diabetes mellitus (T2DM). We previously observed an increase in arrhythmias during spontaneous prolonged hypoglycemia in patients with T2DM. We examined changes in cardiac autonomic function and repolarization during sustained experimental hypoglycemia. Twelve adults with T2DM and 11 age- and BMI-matched control participants without diabetes underwent paired hyperinsulinemic clamps separated by 4 weeks. Glucose was maintained at euglycemia (6.0 mmol/L) or hypoglycemia (2.5 mmol/L) for 1 h. Heart rate, blood pressure, and heart rate variability were assessed every 30 min and corrected QT intervals and T-wave morphology every 60 min. Heart rate initially increased in participants with T2DM but then fell toward baseline despite maintained hypoglycemia at 1 h accompanied by reactivation of vagal tone. In control participants, vagal tone remained depressed during sustained hypoglycemia. Participants with T2DM exhibited greater heterogeneity of repolarization during hypoglycemia as demonstrated by T-wave symmetry and principal component analysis ratio compared with control participants. Epinephrine levels during hypoglycemia were similar between groups. Cardiac autonomic regulation during hypoglycemia appears to be time dependent. Individuals with T2DM demonstrate greater repolarization abnormalities for a given hypoglycemic stimulus despite comparable sympathoadrenal responses. These mechanisms could contribute to arrhythmias during clinical hypoglycemic episodes.

A Comparison of Measurements of Change in Respiratory Status in Spontaneously Breathing Volunteers by the ExSpiron Noninvasive Respiratory Volume Monitor Versus the Capnostream Capnometer.

BACKGROUND: Current respiratory monitoring technologies such as pulse oximetry and capnography have been insufficient to identify early signs of respiratory compromise in nonintubated patients. Pulse oximetry, when used appropriately, will alert the caregiver to an episode of dangerous hypoxemia. However, desaturation lags significantly behind hypoventilation and alarm fatigue due to false alarms poses an additional problem. Capnography, which measures end-tidal CO2 (EtCO2) and respiratory rate (RR), has not been universally used for nonintubated patients for multiple reasons, including the inability to reliably relate EtCO2 to the level of impending respiratory compromise and lack of patient compliance. Serious complications related to respiratory compromise continue to occur as evidenced by the Anesthesiology 2015 Closed Claims Report. The Anesthesia Patient Safety Foundation has stressed the need to improve monitoring modalities so that "no patient will be harmed by opioid-induced respiratory depression." A recently available, Food and Drug Administration-approved noninvasive respiratory volume monitor (RVM) can continuously and accurately monitor actual ventilation metrics: tidal volume, RR, and minute ventilation (MV). We designed this study to compare the capabilities of capnography versus the RVM to detect changes in respiratory metrics. METHODS: Forty-eight volunteer subjects completed the study. RVM measurements (MV and RR) were collected simultaneously with capnography (EtCO2 and RR) using 2 sampling methods (nasal scoop cannula and snorkel mouthpiece with in-line EtCO2 sensor). For each sampling method, each subject performed 6 breathing trials at 3 different prescribed RRs (slow [5 min], normal [12.6 ± 0.6 min], and fast [25 min]). All data are presented as mean ± SEM unless otherwise indicated. RESULTS: Following transitions in prescribed RRs, the RVM reached a new steady state value of MV in 37.7 ± 1.4 seconds while EtCO2 changes were notably slower, often failing to reach a new asymptote before a 2.5-minute threshold. RRs as measured by RVM and capnography during steady breathing were strongly correlated (R = 0.98 ± 0.01, bias = Capnograph-based RR - RVM-based RR = 0.21 ± 1.24 [SD] min). As expected, changes in MV were negatively correlated with changes in EtCO2. However, large changes in MV following transitions in prescribed RR resulted in relatively small changes in EtCO2 (instrument sensitivity = ΔEtCO2/ΔMV = -0.71 ± 0.11 and -0.55 ± 0.11 mm Hg per 1 L/min for nasal and in-line sampling, respectively). Nasal cannula EtCO2 measurements were on average 4 mm Hg lower than in-line measurements. CONCLUSIONS: RVM measurements of MV change more rapidly and by a greater degree than capnography in response to respiratory changes in nonintubated patients. Earlier detection could enable earlier intervention that could potentially reduce frequency and severity of complications due to respiratory depression.