Comparison of patient-reported outcomes of physical activity and accelerometry in people with multiple sclerosis and ambulatory impairment: A cross-sectional study.

BACKGROUND: Accelerometers and patient-reported outcomes (PRO) are used to assess physical activity (PA) in people with multiple sclerosis (pwMS). So far it is unknown, however, whether these assessments represent mobility limitations in pwMS with mild and moderate to severe disability alike. The primary aim of the study was to assess the correlation between accelerometry and International Physical Activity Questionnaire (IPAQ) scores in pwMS with different degrees of ambulatory impairment. Taken its frequent use into account, the Godin Leisure Time Exercise Questionnaire (GLTEQ) was investigated as additional PRO. METHODS: In a prospective cohort of pwMS, correlational analyses were performed between the number of daily steps, time spent in light, moderate to vigorous PA (MVPA) and time spent sitting as assessed using accelerometry (ActiGraph®-GT3X), and the respective IPAQ and GLTEQ scores. Additionally, associations of PA with disease-specific characteristics, aerobic capacity (VO2peak), walking assessments (Timed 25-Foot Walk, T25FW; 2-Minute Walk Test, 2MWT) and walking perception (Multiple Sclerosis Walking Scale-12; MSWS-12) were explored. Patient subgroups with mild (Expanded Disability Status Scale; EDSS score <4.0) and moderate to severe disability (EDSS ≥4.0) were analysed for the impact of ambulatory impairment on PA. Multiple linear regression was used to determine predictors of PA. RESULTS: A total of 56 pwMS completed the study, with a mean (standard deviation, SD) age of 48.4 (10.3) years, disease duration of 14.8 (9.6) years and median (interquartile range) EDSS score of 3.5 (2.0 - 4.4). Moderate to weak correlations were found between daily step count and IPAQ total metabolic equivalent (MET) minutes/week (p < 0.001; r = 0.506), MVPA MET-minutes/week (p < 0.01; r = 0.479) and walking MET-minutes/week (p < 0.05; r = 0.372) in the total cohort. Time spent sitting was inversely correlated with total MET-minutes/week and MVPA MET-minutes/week (p < 0.05; r = -0.358 and r = -0.365). Subgroup analysis revealed, that daily step count was significantly correlated with total MET-minutes/week, MVPA MET-minutes/week and walking MET-minutes/week (p < 0.01, r = 0.569; p < 0.01, r = 0.531 and p < 0.05, r = 0.480, respectively) in the "mild disability" subgroup only, whereas time spent sitting was inversely correlated with total MET-minutes/week (p < 0.05; r = -0.582) in the "moderate to severe disability" subgroup. There was no association between objectively assessed PA and GLTEQ scores in any group. In the total cohort, moderate to weak correlations were found between daily step count and walking assessments (T25FW: p < 0.01, ρ = -0.508; 2MWT: p < 0.01, ρ=0.463) and MSWS-12 (p < 0.001; ρ = -0.609). Moderate to weak correlations were also observed between VO2peak and walking assessments (T25FW: p < 0.01; ρ = -0.516; 2MWT: p < 0.01, ρ=0.480). Multiple linear regression analysis identified disability and VO2peak as predictors of PA (p = 0.045; ß=0.25 and p < 0.001; ß=0.49). CONCLUSION: Significant associations of objective PA measurements using accelerometry with IPAQ were found only in pwMS with "mild disability". In pwMS with "moderate to severe disability", IPAQ did not reflect the objectively assessed amount of PA. In our cohort, GLTEQ showed no association with objectively assessed PA. Thus, an MS-specific self-reported questionnaire for assessing PA is warranted.

Identifying central elements of the therapeutic alliance in the setting of telerehabilitation: A qualitative study.

INTRODUCTION: Therapeutic alliance is a relevant aspect of healthcare and may influence patient outcomes. So far, little is known about the therapeutic alliance in telerehabilitation. PURPOSE: To identify and describe central elements of therapeutic alliance in the setting of telerehabilitation and compare it to those in conventional rehabilitation. METHODS: In this qualitative study, a literature search and in-depth semi-structured interviews with rehabilitation and telerehabilitation experts were conducted from 15.5.-10.8.2020 on elements influencing the therapeutic alliance in rehabilitation and telerehabilitation. Using a combined deductive and inductive approach, qualitative content analysis was used to identify categories and derive central themes. RESULTS: The elements bond, communication, agreement on goals and tasks and external factors were identified in the literature search and informed the development of the interview guide. Twelve purposively sampled experts from the fields of physiotherapy, occupational therapy, speech and language therapy, psychology, general medicine, sports science and telerehabilitation software development participated in the interviews. We identified three central themes: building effective communication; nurturing a mutual relationship of trust and respect; and agreement on goals and tasks and drivers of motivation. CONCLUSIONS: In this qualitative study, key elements of therapeutic alliance in rehabilitation confirmed those reported in the literature, with additional elements in telerehabilitation comprising support from others for ensuring physical safety and technical connectedness, caregivers acting as co-therapists and applying professional touch, and promoting patient autonomy and motivation using specific strategies.

Factors influencing the willingness to adopt telerehabilitation among rehabilitation professionals in Austria and Germany: a survey comparing data before and during COVID-19.

PURPOSE: To investigate determinants of willingness to adopt telerehabilitation, willingness of technology use, core affect regarding using telerehabilitation, and digital competencies in rehabilitation professionals in Austria and Germany before and during the COVID-19 pandemic. MATERIALS AND METHODS: A cross-sectional paper-based and online survey was conducted before and during COVID-19, respectively, with three cohorts of rehabilitation professionals. Outcomes were the willingness to adopt telerehabilitation evaluated using the extended Unified Theory of Acceptance and Use of Technology; willingness of technology use using the short scale for assessing the willingness of technology use; digital competencies and core affect using the Digital Competence Framework and semantic differential, respectively. Multivariate ordinal regression analysis was performed to determine predictors. RESULTS: Included were 603 rehabilitation professionals. Analysis revealed differences between Austria and Germany and before and during the pandemic for most outcomes. German residency, the pandemic, and a higher educational level were most important predictors of higher willingness to adopt telerehabilitation, willingness of technology use, digital competencies, and positive core affect.The pandemic increased most aspects of willingness to adopt telerehabilitation, willingness of technology use, digital competencies, and positive core affect. Results confirm that rehabilitation professionals with higher degrees are more prone to adopt innovations in healthcare.Registration: German Clinical Trials Register (DRKS00021464)IMPLICATIONS FOR REHABILITATIONThe willingness to adopt telerehabilitation is associated with external factors increasing the need for alternative rehabilitation delivery, such as COVID-19, and with financial facilitators, such as reimbursement.As the willingness to adopt telerehabilitation is higher among speech and language therapists and dietitians, efforts are necessary to enhance its use in physiotherapists and occupational therapists.As a higher willingness to adopt telerehabilitation was observed in younger rehabilitation professionals and those with higher education, increasing the importance of telerehabilitation in education curricula and further knowledge transfer into practice for those already working in the field seems necessary.

Combining specific task-oriented training with manual therapy to improve balance and mobility in patients after stroke: a mixed methods pilot randomised controlled trial.

PURPOSE: In absence of existing studies, to describe changes in balance and mobility, following specific task-oriented training (TOT), its combination with talocrural manual therapy (MT-TOT) or no intervention, in chronic stroke patients. To explore the feasibility of a full-scale randomised controlled trial (RCT) based on criteria of recruitment, retention and adherence rates, adverse events, falls and acceptability of the intervention. MATERIALS AND METHODS: Using an assessor-blinded pilot RCT, 36 stroke patients were allocated to either MT-TOT, TOT, or controls. Supervised interventions were performed 45 min, 2×/weekly, for 4 weeks, and home-based practice 20 min, 4x/weekly for 4 weeks. Qualitative interviews evaluated intervention acceptability. Outcomes of balance, mobility, ankle dorsiflexion range of motion (ROM), falls and health-related quality of life (HRQoL) were assessed at baseline, post-intervention and 4-week follow-up. RESULTS: Preliminary efficacy of MT-TOT and TOT was shown in improving balance (effect size 0.714), walking speed (0.683), mobility (0.265), dual-tasking mobility (0.595), falls (0.037), active and passive talocrural ROM (0.603; 0.751) and activities and social participation related HRQoL domains (0.332-0.784) in stroke patients. The feasibility of a larger RCT was confirmed. CONCLUSIONS: Specific MT-TOT and TOT appeared effective and are feasible in stroke patients. A larger RCT is needed to validate the results.Trial Registration: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

A specific goal- and task-oriented training involving timed mobility and dynamic balance activities based on the demands of daily life, of high intensity and progressed in difficulty according to predefined criteria is feasible in patients after stroke.In this mixed methods pilot study patients indicated high acceptability of task-oriented training with and without ankle mobilisations, with their descriptions being in line with the Theoretical Framework of Acceptability.Specific task-oriented training and its combination with talocrural joint manual therapy improved balance, mobility, talocrural dorsiflexion range of motion and some domains of health-related quality of life in people after stroke.

[Psychometric Evaluation of the 'German Neurological Fatigue Index for Multiple Sclerosis (NFI-MS-G)' in a Sample of Rehabilitation Patients with Multiple Sclerosis]. / Psychometrische Prüfung des deutschsprachigen "Neurologischen Fragebogens zur Müdigkeit bei Multipler Sklerose (NFI-MS-G)" bei Rehabilitanden mit Multipler Sklerose.

PURPOSE: The purpose of this study was to provide a patient-reported outcome measure for people with multiple sclerosis (MS) comprehensively reflecting the construct of fatigue and developed upon the assumptions of the Rasch model. The Neurological Fatigue Index - Multiple Sclerosis (NFI-MS) is based on both a medical and patient-described symptom framework of fatigue and has been validated. Therefore, in this study the German version of the NFI-MS (NFI-MS-G) consisting of a physical and cognitive subscale and a summary scale was validated. METHOD: In this bi-centre-study, 309 people with MS undergoing outpatient rehabilitation or being≥2 months before or after their inpatient rehabilitation completed the German NFI-MS-G twice within 14-21 days together with other questionnaires. Correlation with established questionnaires and Rasch analysis were used for its validation. Additionally, psychometric properties of known-groups validity, internal consistency, test-retest reliability, measurement precision and readability were tested. Finally, the English NFI-MS and German NFI-MS-G were compared with each other to equate the language versions. RESULTS: The NFI-MS-G showed good internal construct validity, convergent and known-groups validity and internal consistency (Cronbach's alpha 0.84-0.93). The physical subscale showed minor local dependencies between items 1 and 7, 2 and 3 and 4 to 6, that could be treated by combining the respective items to testlets. Unidimensionality was found for the physical and cognitive subscales but not for the summary scale. Replacing the summary scale, a 2-domains subtest measuring the higher-order construct of fatigue was created. Good test-retest reliability (Lin's concordance correlation coefficient of 0.86-0.90) and low floor and ceiling effects were demonstrated. The NFI-MS-G was found easily readable and invariant across groups of gender, age, disease duration, timepoint and centre. CONCLUSION: The German version of the NFI-MS comprehensively represents the construct of fatigue and has adequate psychometric properties. The German version differs from the English original version with respect to a lack of unidimensionality of the summary scale and minor local dependencies of the physical subscale that could be canceled out using a testlet analysis.

Factors and strategies affecting motor imagery ability in people with multiple sclerosis: a systematic review.

BACKGROUND: Although growing evidence has shown beneficial effects of motor imagery (MI) training in different populations including people with multiple sclerosis (pwMS), not all patients with neurological diseases may benefit from MI. OBJECTIVES: To investigate factors and strategies affecting and enhancing MI ability in pwMS. DATA SOURCES: MEDLINE/PubMed, PsycINFO, Cochrane Library, Scopus, EMBASE, EBSCOhost, Web of Science and REHABDATA databases, clinical trials registries, dissertation repositories, study bibliographies and internet search engines were searched through August 2021. STUDY SELECTION: Any study type but single case studies investigating factors or strategies contributing to MI ability in pwMS. STUDY APPRAISAL AND SYNTHESIS METHODS: Risk of bias (RoB) was assessed using the Joanna Briggs Institute Checklist for Case-Control and Analytical Cross-Sectional Studies and Cochrane RoB-2.0 tool for randomised trials. A qualitative synthesis was performed summarising main results. RESULTS: Eight databases, 4 trial registries, 9 dissertation repositories, and 1 internet search engine were searched. Fourteen studies including 366 pwMS and 236 healthy controls were included. Most frequently, cognitive impairment was reported as a negative factor influencing MI ability in pwMS. Other negative factors were cognitive fatigue and disability. Inconsistent evidence was found on the contribution of MS phenotype, anxiety, and depression. Using a theory-based MI framework and familiarisation to MI and external cueing may enhance MI ability. LIMITATIONS: Eligible studies were highly heterogeneous. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS: Cognitive impairment, cognitive fatigue and disability negatively influence MI ability in pwMS. Visual and/or auditory cueing of MI are strategies for facilitating MI ability. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020173081 CONTRIBUTION OF THE PAPER.

ExerG: adapting an exergame training solution to the needs of older adults using focus group and expert interviews.

BACKGROUND: Exergames are playful technology-based exercise programs. They train physical and cognitive functions to preserve independence in older adults (OAs) with disabilities in daily activities and may reduce their risk of falling. This study gathered in-depth knowledge and understanding of three different user groups' experiences in and relevant needs, worries, preferences, and expectations of technology-based training, to develop an exergame training device for OAs. METHODS: We conducted a qualitative study using semi-structured focus group interviews of primary (OAs in geriatric or neurological rehabilitation) and secondary (health professionals) end users, as well as expert interviews of tertiary end users (health insurance experts or similar), exploring user perspectives on adjusting an existing exergame to OAs' needs. Voice-recorded interviews were transcribed by researchers and analyzed using thematic analysis (TA) following an inductive, data-driven, iterative approach. RESULTS: We interviewed 24 primary, 18 secondary, and 9 tertiary end users at two rehabilitation centers in Austria and Switzerland. Our TA approach identified five to six themes per user group. Themes in the primary end user group reflected aspects of safety, training goals, individuality, game environment, social interactions, and physical and technical overload. Themes in the secondary end user group comprised facets of meaningfulness, distraction through the game environment, safety, gamification elements, the availability and accessibility of the exergame. Tertiary end users' themes addressed aspects of financial reimbursement, suitable target populations, professional training for the handling of exergame devices, training goals, and concerns about the use of exergames in geriatric rehabilitation. CONCLUSIONS: In conclusion, an exergame for OAs must be safe, motivating and fully adaptable to the target group while promoting the return to or preservation of autonomy and independence in daily life. Our findings contribute to developing hard- and software extensions for the ExerG training device. Further research is needed to expand the validity of our findings to larger populations.

The Effects of Exercise Therapy Moderated by Sex in Rehabilitation of COVID-19.

Standardized exercise therapy programs in pulmonary rehabilitation have been shown to improve physical performance and lung function parameters in post-acute COVID-19 patients. However, it has not been investigated if these positive effects are equally beneficial for both sexes. The purpose of this study was to analyze outcomes of a pulmonary rehabilitation program with respect to sex differences, in order to identify sex-specific pulmonary rehabilitation requirements. Data of 233 post-acute COVID-19 patients (40.4% females) were analyzed before and after a three-week standardized pulmonary rehabilitation program. Lung function parameters were assessed using body-plethysmography and functional exercise capacity was measured by the Six-Minute Walk Test. At post-rehabilitation, females showed a significantly smaller improvement in maximal inspiration capacity and forced expiratory volume (F=5.86, ω2=.02; p<0.05) than males. Exercise capacity improvements between men and women did not differ statistically. Females made greater progress towards reference values of exercise capacity (T(231)=-3.04; p<0.01) and forced expiratory volume in the first second (T(231)=2.83; p<0.01) than males. Sex differences in the improvement of lung function parameters seem to exist and should be considered when personalizing standardized exercise therapies in pulmonary rehabilitation.

Effects of actual and imagined music-cued gait training on motor functioning and brain activity in people with multiple sclerosis: protocol of a randomised parallel multicentre trial.

INTRODUCTION: Motor imagery (MI) refers to the mental rehearsal of a physical action without muscular activity. Our previous studies showed that MI combined with rhythmic-auditory cues improved walking, fatigue and quality of life (QoL) in people with multiple sclerosis (pwMS). Largest improvements were seen after music and verbally cued MI. It is unclear whether actual cued gait training achieves similar effects on walking as cued MI in pwMS. Furthermore, in pwMS it is unknown whether any of these interventions leads to changes in brain activation. The purpose of this study is therefore to compare the effects of imagined and actual cued gait training and a combination thereof on walking, brain activation patterns, fatigue, cognitive and emotional functioning in pwMS. METHODS AND ANALYSIS: A prospective double-blind randomised parallel multicentre trial will be conducted in 132 pwMS with mild to moderate disability. Randomised into three groups, participants will receive music, metronome and verbal cueing, plus MI of walking (1), MI combined with actual gait training (2) or actual gait training (3) for 30 min, 4× per week for 4 weeks. Supported by weekly phone calls, participants will practise at home, guided by recorded instructions. Primary endpoints will be walking speed (Timed 25-Foot Walk) and distance (2 min Walk Test). Secondary endpoints will be brain activation patterns, fatigue, QoL, MI ability, anxiety, depression, cognitive functioning, music-induced motivation-to-move, pleasure, arousal and self-efficacy. Data will be collected at baseline, postintervention and 3-month follow-up. MRI reference values will be generated using 15 matched healthy controls. ETHICS AND DISSEMINATION: This study follows the Standard Protocol Items: Recommendations for Interventional Trials-PRO Extension. Ethical approval was received from the Ethics Committees of the Medical Universities of Innsbruck (1347/2020) and Graz (33-056 ex 20/21), Austria. Results will be disseminated via national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00023978.

Successful long-term management of spasticity in people with multiple sclerosis using a software application: Results from a randomized, controlled, multicenter study.

BACKGROUND AND PURPOSE: Successful long-term treatment of spasticity in people with multiple sclerosis (pwMS) is challenging. We investigated the effects of multidisciplinary inpatient rehabilitation (MIR) and an individualized self-training program delivered by an app on spasticity in pwMS. METHODS: First, we assessed the efficacy of 4-week MIR in ambulatory pwMS (Expanded Disability Status Scale < 7.0) with moderate to severe lower limb spasticity (defined by ≥4 points on the Numeric Rating Scale for spasticity [NRSs]) in a cohort of 115 pwMS at seven rehabilitation centers in Austria. In the case of a clinically relevant improvement in spasticity of ≥20% on the NRSs following MIR (n = 94), pwMS were randomly allocated in a 1:1 ratio to either the newly designed MS-Spasticity App or to a paper-based self-training program for 12 weeks. The primary outcome was change in NRSs (German Clinical Trials Registry DRKS00023960). RESULTS: MIR led to a significant reduction of 2.0 points on the NRSs (95% confidence interval [CI] = 2.5-2.0, p < 0.000). MIR was further associated with a statistically significant improvement in spasticity on the Modified Ashworth Scale, strength, and all mobility outcomes. Following MIR, self-training with the MS-Spasticity App was associated with a sustained positive effect on the NRSs, whereas paper-based self-training led to a worsening in spasticity (median NRSs difference = 1.0, 95% CI = 1.7-0.3, p = 0.009). The MS-Spasticity App was also associated with a significantly better adherence to self-training (95% vs. 72% completion rate, p < 0.001). CONCLUSIONS: In pwMS, MIR is able to significantly improve lower limb spasticity, strength, and mobility. Following MIR, an individually tailored antispasticity program delivered by an app leads to sustained positive long-term management.

Feasibility of an individualised, task-oriented, video-supported home exercise programme for arm function in patients in the subacute phase after stroke: protocol of a randomised controlled pilot study.

INTRODUCTION: Stroke rehabilitation guidelines suggest a high-frequency task-oriented training at high intensity. A targeted and self-paced daily training with intermittent supervision is recommended to improve patients' self-management and functional output. So far, there is conflicting evidence concerning the most effective home-training delivery method. METHODS AND ANALYSIS: The purpose of this pilot study is to compare the feasibility and preliminary effects of task-oriented home-exercises in patients in the subacute stage after stroke. Twenty-four patients will be randomised (1:1) to a Video group (a) or Paper group (b) of an individualised, task-oriented home-training (50 min, 6×/week, for 4 weeks) based on Wulf and Lewthwaite's Optimizing Performance Through Intrinsic Motivation and Attention for Learning theory of motor learning. Patient-relevant goals will be identified using Goal Attainment Scaling and exercises progressively adapted. Semistructured interviews and a logbook will be used to monitor adherence, arm use and acceptability. Primary outcome will be the feasibility of the methods and a full-scale trial employing predefined feasibility criteria (recruitment, retention and adherence rates, patients' satisfaction with the home-exercise programme and their progress, affected hand use and acceptance of the intervention). Assessed at baseline, post intervention and 4-week follow-up, secondary outcomes include self-perceived hand and arm use, actual upper extremity function and dexterity, hand strength, independence in activities of daily living and health-related quality of life. Interview data will be analysed using qualitative content analysis. Medians (ranges) will be reported for ordinal data, means (SD) for continuous and frequency (percentage) for nominal data. ETHICS AND DISSEMINATION: This study follows the Standard Protocol Items: Recommendations for Interventional Trials-Patient-Reported Outcome (PRO) Extension guideline. Ethical approval was received from the Ethics Committee of the Medical University of Innsbruck, Austria (1304/2020). Written informed consent will be obtained from all participants prior to data collection. Study results will be disseminated to participating patients, patient organisations, via the clinic's homepage, relevant conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS-ID: DRKS00023395.Study protocol, second revision, 5 December 2021.

Research interrupted: The impact of the COVID-19 pandemic on multiple sclerosis research in the field of rehabilitation and quality of life.

BACKGROUND: The COVID-19 pandemic has likely had a negative impact on rehabilitation and quality of life (QoL) research in multiple sclerosis (MS). METHOD: We explored perceived barriers to research among 87 researchers, representing 18 countries, both prior to and since COVID-19. RESULTS: A Wilcoxon signed-rank test found that significantly more researchers reported experiencing barriers to research since the onset of the pandemic compared to pre-COVID-19 (p < .001), with 78% of respondents reporting at least some barriers since COVID-19. The most commonly-cited barriers related to participant access (n = 38) and interruptions/delays to projects (n = 19). Although no gender differences were found in the number of barriers reported, female respondents were more likely to cite time or competing demands as barriers to research. Females were also more likely to perceive being negatively impacted by the pandemic compared to other genders (p = .007). CONCLUSIONS: Implications for the future landscape of rehabilitation research in MS are discussed.

Feasibility of motor imagery and effects of activating and relaxing practice on autonomic functions in healthy young adults: A randomised, controlled, assessor-blinded, pilot trial.

INTRODUCTION: Motor imagery (MI) is the mental rehearsal of a motor task. Between real and imagined movements, a functional equivalence has been described regarding timing and brain activation. The primary study aim was to investigate the feasibility of MI training focusing on the autonomic function in healthy young people. Further aims were to evaluate participants' MI abilities and compare preliminary effects of activating and relaxing MI on autonomic function and against controls. METHODS: A single-blinded randomised controlled pilot trial was performed. Participants were randomised to the activating MI (1), relaxing MI (2), or control (3) group. Following a MI familiarisation, they practiced home-based kinaesthetic MI for 17 minutes, 5 times/week for 2 weeks. Participants were called once for support. The primary outcome was the feasibility of a full-scale randomised controlled trial using predefined criteria. Secondary outcomes were participants' MI ability using the Movement Imagery Questionnaire-Revised, mental chronometry tests, hand laterality judgement and semi-structured interviews, autonomic function. RESULTS: A total of 35 participants completed the study. The feasibility of a larger study was confirmed, despite 35% attrition related to the COVID-19 pandemic. Excellent MI capabilities were seen in participants, and significant correlations between MI ability measures. Interview results showed that participants accepted or liked both interventions. Seven major themes and insider recommendations for MI interventions emerged. No significant differences and negligible to medium effects were observed in MI ability or autonomic function between baseline and post-intervention measures or between groups. CONCLUSIONS: Results showed that neither activating nor relaxing MI seems to change autonomic function in healthy individuals. Further adequately powered studies are required to answer open questions remaining from this study. Future studies should investigate effects of different MI types over a longer period, to rule out habituation and assess autonomic function at several time points and simultaneously with MI.

Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial.

BACKGROUND: Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. METHODS: This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients' skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. DISCUSSION: Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068 .

Differential Binding of Autoantibodies to MOG Isoforms in Inflammatory Demyelinating Diseases.

OBJECTIVE: To analyze serum immunoglobulin G (IgG) antibodies to major isoforms of myelin oligodendrocyte glycoprotein (MOG-alpha 1-3 and beta 1-3) in patients with inflammatory demyelinating diseases. METHODS: Retrospective case-control study using 378 serum samples from patients with multiple sclerosis (MS), patients with non-MS demyelinating disease, and healthy controls with MOG alpha-1-IgG positive (n = 202) or negative serostatus (n = 176). Samples were analyzed for their reactivity to human, mouse, and rat MOG isoforms with and without mutations in the extracellular MOG Ig domain (MOG-ecIgD), soluble MOG-ecIgD, and myelin from multiple species using live cell-based, tissue immunofluorescence assays and ELISA. RESULTS: The strongest IgG reactivities were directed against the longest MOG isoforms alpha-1 (the currently used standard test for MOG-IgG) and beta-1, whereas the other isoforms were less frequently recognized. Using principal component analysis, we identified 3 different binding patterns associated with non-MS disease: (1) isolated reactivity to MOG-alpha-1/beta-1 (n = 73), (2) binding to MOG-alpha-1/beta-1 and at least one other alpha, but no beta isoform (n = 64), and (3) reactivity to all 6 MOG isoforms (n = 65). The remaining samples were negative (n = 176) for MOG-IgG. These MOG isoform binding patterns were associated with a non-MS demyelinating disease, but there were no differences in clinical phenotypes or disease course. The 3 MOG isoform patterns had distinct immunologic characteristics such as differential binding to soluble MOG-ecIgD, sensitivity to MOG mutations, and binding to human MOG in ELISA. CONCLUSIONS: The novel finding of differential MOG isoform binding patterns could inform future studies on the refinement of MOG-IgG assays and the pathophysiologic role of MOG-IgG.

German translation, cultural adaptation and validation of the unidimensional self-efficacy scale for multiple sclerosis.

BACKGROUND: Self-efficacy concerns individuals' beliefs in their capability to exercise control in specific situations and complete tasks successfully. In people with multiple sclerosis (PwMS), self-efficacy has been associated with physical activity levels and quality of life. As a validated German language self-efficacy scale for PwMS is missing the aims of this study were to translate the Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS) into German, establish face and content validity and cultural adaptation of the German version for PwMS in Austria. A further aim was to validate the German USE-MS (USE-MS-G) in PwMS. METHODS: Permission to translate and validate the USE-MS was received from the scale developers. Following guidelines for translation and validation of questionnaires and applying Bandura's concept of self-efficacy, the USE-MS was forward-backward translated with content and face validity established. Cultural adaptation for Austria was performed using cognitive patient interviews. Reliability was assessed using Cronbach's alpha, Person separation index and Lin's concordance correlation coefficient. Rasch analysis was employed to assess construct validity. Comparison was made to scales for resilience, general self-efficacy, anxiety and depression, multiple sclerosis fatigue and health-related quality of life. Data were also pooled with an historic English dataset to compare the English and German language versions. RESULTS: The translation and cultural adaptation were successfully performed in the adaptation process of the USE-MS-G. Pretesting was conducted in 30 PwMS, the validation of the final USE-MS-G involved 309 PwMS with minimal to severe disability. The USE-MS-G was found to be valid against the Rasch model when fitting scale data using a bifactor solution of two super-items. It was shown to be unidimensional, free from differential item functioning and well targeted to the study population. Excellent convergent and known-groups validity, internal consistency, person separation reliability and test-retest reliability were shown for the USE-MS-G. Pooling of the English and German datasets confirmed invariance of item difficulties between languages. CONCLUSION: The USE-MS-G is a robust, valid and reliable scale to assess self-efficacy in PwMS and can generate interval level data on an equivalent metric to the UK version. TRIAL REGISTRATION: ISRCTN Registry; ISRCTN14843579 ; prospectively registered on 02. 01. 2019.

Physiotherapy improves motor function in patients with the Parkinson variant of multiple system atrophy: A prospective trial.

BACKGROUND AND OBJECTIVES: Gait impairment and reduced mobility are disabling symptoms of multiple system atrophy. While physiotherapy is increasingly recognized as a valuable supplement to pharmacotherapy for patients with Parkinson's disease, data on the efficacy of physiotherapy for multiple system atrophy are lacking. This study aimed to explore the feasibility of two consecutive exercise-based interventions in patients with multiple system atrophy. SUBJECTS AND METHODS: We included 10 patients with the parkinsonian variant of multiple system atrophy and 10 patients with Parkinson's disease, matched for gender and Hoehn & Yahr stage (≤3). Interventions consisted of a five-day inpatient physiotherapy program followed by a five-week unsupervised home-based exercise program. Outcomes included instrumented gait analysis, patient questionnaires, clinical rating scales and physical tests. Patients were examined at baseline, after the first inpatient treatment and again after the home-based intervention. Additionally, a structured telephone interview was performed immediately after the second intervention period. RESULTS: Both patient groups exhibited a similar improvement of gait after the interventions, as measured by instrumented gait analysis. These effects reached their maximum level after inpatient physiotherapy and remained stable following the home-based exercise program. Patient questionnaires also showed improvements after the interventions, but motor clinical rating scales did not. CONCLUSION: Our pilot results suggest that a short-term bout of physiotherapy is feasible, safe and improves gait performance in patients with multiple system atrophy. This highlights the potential of physiotherapy for this disabling condition where pharmacotherapy typically achieves poor effects. The present findings warrant a larger controlled study.

German translation, cultural adaption and validation of the unidimensional self-efficacy scale for multiple sclerosis: a study protocol.

INTRODUCTION: Self-efficacy refers to individuals' confidence in their ability to perform relevant tasks to accomplish desired goals. This is independent of their actual abilities. In people with multiple sclerosis (MS), self-efficacy has been shown to powerfully influence motivation and health-related behaviour, such as adherence to prescribed treatment or physical activity. So far, a rigorously tested German language self-efficacy questionnaire for people with MS is missing. METHODS: The purpose of this study is to translate the original Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS) into German and to validate the German USE-MS (USE-MS-G). Based on Bandura's concept of self-efficacy and international guidelines for questionnaire development, the patient-led development of the pre-final German version will involve a forward-backward translation process, synthesis of translations, expert committee review and consensus with the original test developers. At two centres in Tyrol, Austria, content and face validity and cultural adaption for Austria will be established using face-to-face semistructured cognitive interviews of 30 people with MS (PwMS). A further 292 PwMS with minimal to severe disability will be tested at two timepoints to validate the USE-MS-G. RESULTS: Mixed methods analyses will be applied. Interviews will be transcribed and analysed employing qualitative content analysis. External validity will be explored using Spearman's Rank correlation coefficients of the USE-MS-G with the 13-item Resilience Scale, General Self-Efficacy Scale, Multiple Sclerosis International Quality of Life questionnaire, Hospital Anxiety and Depression Scale and MS-specific Neurological Fatigue Index. Test-retest reliability, internal consistency and floor and ceiling effects will be evaluated. Internal validity will be examined using Rasch analysis. ETHICS AND DISSEMINATION: Ethical approval was received from the Ethics Committee of the Medical University of Innsbruck, Austria (reference number EK1260/2018; 13.12.2018). Results from this study will be disseminated to the participants and MS Societies, and to clinicians and researchers through peer-reviewed publications and conferences. STUDY REGISTRATION: ISRCTN Registry; trial ID ISRCTN14843579; prospectively registered on 02. 01. 2019; http://www.isrctn.com/ISRCTN14843579.

Effects and mechanisms of differently cued and non-cued motor imagery in people with multiple sclerosis: A randomised controlled trial.

BACKGROUND: Walking impairment and fatigue are prevalent symptoms in people with multiple sclerosis (PwMS). Motor imagery (MI) with rhythmic auditory cueing improved walking in PwMS, but so far, the underlying mechanisms are not fully explored. OBJECTIVE: This study investigated the effects and mechanisms of differently cued and non-cued MI on walking, fatigue and quality of life (QoL) in PwMS. METHODS: A total of 60 PwMS with mild to moderate disability were randomised to music- and verbally cued MI (MVMI), music-cued MI (MMI) or MI. Participants practised cued or non-cued MI of walking for 17 minutes, six times per week for 4 weeks at home. Primary outcomes were walking speed (timed 25-foot walk) and walking distance (6-minute walk test). RESULTS: A total of 59 participants completed the study. All interventions induced significant improvements in walking speed and distance, while MVMI was superior. After cued MI, fatigue and QoL significantly improved, with greatest changes seen after MVMI. All participants showed high MI ability. Post-intervention, sensorimotor synchronisation (SMS) was significantly more accurate after cued MI. CONCLUSION: All interventions significantly improved walking. MVMI was superior in improving walking, fatigue and QoL. Results suggest that MI and SMS were mechanisms of action.