Screening Strategies for Sleep-Disordered Breathing in Patients With Spinal Cord Injury in a Tertiary Care Rehabilitation Center.

BACKGROUND: Sleep-disordered breathing (SDB) is frequent in patients with spinal-cord injury (SCI). However, SDB is frequently underdiagnosed due to limited access to diagnostic testing and knowledge about the condition. Moreover, SDB heterogeneity (sleep apnea, obstructive sleep apnea or central sleep apnea and nocturnal alveolar hypoventilation) implies complex evaluation of both nocturnal respiratory effort and hypercapnia. The aim of this study was to compare different screening strategies for an SDB diagnosis in patients with SCI. METHODS: This was a retrospective analysis of data from subjects with SCI followed up in a tertiary-care rehabilitation center with a specialized sleep unit. Subjective (questionnaires) and objective data (polysomnography [PSG]), SpO2 extracted from the PSG, morning blood gases, and nocturnal transcutaneous CO2 (PtcCO2 ) were collected and analyzed. A retrospective comparison of different strategies for SDB screening was carried out. Each strategy was compared (alone and in combination) with the standard of care for sleep apnea (PSG) and nocturnal alveolar hypoventilation (PtcCO2 ) diagnosis. The performance of the usual cutoff and visual analysis was studied. RESULTS: Among 190 subjects with SCI who underwent a full night's PSG, data were available for 104 questionnaires and 162 with oximetry. Nocturnal alveolar hypoventilation was screened by PtcCO2 and blood gases in 52 subjects with SCI. Questionnaires (the modified Screening for Obstructive Sleep Apnea in Tetraplegia and the Epworth Sleepiness Scale) had poor performance for identifying sleep apnea and did not identify nocturnal alveolar hypoventilation. SpO2 (oxygen desaturation index score ≥ 13) and visual analysis of SpO2 were good at identifying sleep apnea but insufficient to identify nocturnal alveolar hypoventilation. Diurnal blood gases were poor predictors of nocturnal alveolar hypoventilation. CONCLUSIONS: Questionnaires were of limited use in subjects with SCI, but the oxygen desaturation index derived from oximetry performed well for sleep apnea screening. Both diurnal blood gases and oximetry visual analysis were insufficient for nocturnal alveolar hypoventilation screening. PtcCO2 monitoring should be mandatory and ideally combined with PSG given the heterogeneity of SDB phenotypes and associated sleep comorbidities of patients with SCI.

Concomitant Botulinum Toxin Injections for Neurogenic Detrusor Overactivity and Spasticity-A Retrospective Analysis of Practice and Safety.

As multiple indications for botulinum toxin injections (BTIs) can coexist for neurological patients, there are to date no description of concomitant injections (CIs) to treat both spasticity and neurogenic detrusor overactivity incontinence (NDOI) in patients with spinal cord injuries (SCIs) and multiple sclerosis (MS). We therefore identified patients followed at our institution by health data hub digging, using a specific procedure coding system in use in France, who have been treated at least once with detrusor and skeletal muscle BTIs within the same 1-month period, over the past 5 years (2017-2021). We analyzed 72 patients representing 319 CIs. Fifty (69%) were male, and the patients were mostly SCI (76%) and MS (18%) patients and were treated by a mean number of CIs of 4.4 ± 3.6 [1-14]. The mean cumulative dose was 442.1 ± 98.8 U, and 95% of CIs were performed within a 72 h timeframe. Among all CIs, five patients had symptoms evocative of distant spread but only one had a confirmed pathological jitter in single-fiber EMG. Eleven discontinued CIs for surgical alternatives: enterocystoplasty (five), tenotomy (three), intrathecal baclofen (two) and neurotomy (one). Concomitant BTIs for treating both spasticity and NDOI at the same time appeared safe when performed within a short delay and in compliance with actual knowledge for maximum doses.

Melatonin secretion and sleep disorders in patients with spinal cord injuries.

STUDY DESIGN: Prospective observational study. OBJECTIVES: To evaluate melatonin secretion, daytime sleepiness and sleep disorders in patients with spinal cord injuries (SCI), and their association with lesion level. SETTING: Specialized neuro rehabilitation hospital in France METHODS: Prospective observational study of patients aged over 18 hospitalized in for spinal cord injury. Sleep quality was measured with the Pittsburgh Sleep Quality Index (PQSI), daytime sleepiness with the Epworth Sleepiness scale (ESS), and melatonin secretion by 24 h urinary dosage of 6-sulphatoxy-melatonin. RESULTS: 213 patients were screened, 21 patients were included: 17 complete (AIS A) and 4 lesions (AIS B), 76% of traumatic origin with 12 tetraplegic and 9 paraplegic, mean 10 (range 0.5-40) years after injury. Mean age was 46.8 ± 14.7 years, mean BMI 23.56 ± 4.1 and men outnumbered women (15 vs 6). Melatonin secretion was analyzed by 24 h secretion and by secretion profile. Comparing retained vs abolished secretion, only 23% (4/17) of patients with a lesion above T8 retained melatonin secretion, compared to 80% (4/5) with a lesion below T8 (p = 0.022). Non significant differences were found in secretion profile in patients who retained secretion: no patient with a lesion above T8 had a normal secretion profile compared to 50% with a lesion below T8 and in the impact of partial vs total lesions above T8 in whom 17% (2/12) of complete ASIA-A lesions and 50% (2/4) of incomplete lesions retained secretion. CONCLUSION: Lesions of the spinal cord above T8 are strongly associated with abolition of melatonin secretion.

Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care.

BACKGROUND: Fatigue is a disabling symptom of multiple sclerosis (MS). The lack of effective therapeutics has promoted the development of cognitive behavioural therapy (CBT)-based fatigue management programmes. However, their efficacy does not sustain over time. We proposed to test the long-term effectiveness of a 6-week fatigue programme supplemented with four booster sessions ('FACETS+') in patients with relapsing remitting MS (RRMS) and fatigue. METHODS: This multicentre, randomised, controlled, open-label, parallel-group trial versus standard care enrolled patients with RRMS and fatigue. Participants were randomised to either FACETS+ plus standard care or standard care alone. The primary outcome measure was fatigue impact (Modified Fatigue Impact Scale (MFIS) at 12 months) based on intention-to-treat analyses. RESULTS: From May 2017 to September 2020, 162 patients were screened; 105 were randomly assigned to FACETS+ (n=57) or standard care (n=48) and 88 completed the primary outcome assessment for the MFIS. At month 12, participants showed improved MFIS compared with baseline in the intervention group (mean difference (MD)=14.0 points; (95% CI 6.45 to 21.5)) and the control group (MD=6.1 points; (95% CI -0.30 to 12.5)) with a significant between-group difference in favour of the intervention group (adjusted MD=7.89 points; (95% CI 1.26 to 14.52), standardised effect size=0.52, p=0.021). No trial-related serious adverse events were reported. CONCLUSIONS: A 6-week CBT-based programme with four booster sessions is superior to standard care alone to treat MS-related fatigue in the long term (12 months follow-up). The results support the use of the FACETS+ programme for the treatment of MS-related fatigue. TRIAL REGISTRATION NUMBER: NCT03758820.

Adherence to continuous positive airway pressure therapy in patients with spinal cord injury and obstructive sleep apnea: trajectories and predictors.

PURPOSE: To identify specific determinants of non-adherence or cessation of continuous positive airway pressure (CPAP) therapy in a population of patients with spinal cord injuries (SCI). METHODS: Retrospective analysis of data from patients with SCI who underwent a full night supervised polysomnography between 2015 and 2021 and presented with moderate to severe obstructive sleep apnea (OSA) and for whom CPAP was indicated. Adherence was studied at 1, 6, and 12 months. Univariate and multivariate analyses were performed to identify factors associated with non-adherence (< 4 h per night or CPAP cessation). Factors studied were demographic and disease-related data and both subjective and objective sleep parameters. RESULTS: A total of 60 patients were included (40% cervical SCI). In univariate analysis, the only predictive parameters of non-adherence observed at 1, 6, and 12 months were the average use of CPAP on the 1st night (p = 0.02) and over the 1st week (p ≤ 0.001). A complete lesion (AIS-A) was predictive of non-adherence at 1 and 6 months (p = 0.02 at 6 months), while mask leakage was associated with non-adherence at 12 months (p = 0.02). Upper limb autonomy and the presence of family caregivers did not appear to be protective. In multivariate analysis, only the average use in the first week remained predictive of adherence (> 4 h) in the short, medium and long term. CONCLUSION: In patients with SCI and OSA, the 1st week of CPAP treatment seems to be determinant of short-, medium-, and long-term CPAP adherence. Support for SCI patients from the start of treatment is essential and may help avoid treatment failures.

Selecting Goals and Target Muscles for Botulinum Toxin A Injection Using the Goal Oriented Facilitated Approach to Spasticity Treatment (GO-FAST) Tool.

The objective of this article is to introduce the GO-FAST Tool (developed by the Toxnet group) to clinicians working in the field of neurological rehabilitation, specifically post-stroke spasticity management. The concepts utilized in the Tool and described in this article can be broadly grouped into five topics: the principles of patient-centred goal-setting; an algorithm for setting SMART (specific, measurable, attainable, realistic, and timed) treatment goals; goal-related target muscles and botulinum toxin type A dose determinants; goal attainment follow-up, scoring, and interpretation; and the multimodal approach to spasticity management. The Tool can enhance clinical practice by providing guided assistance with goal-setting and target muscle selection for botulinum toxin type A treatment. It also provides support with the follow-up evaluation of goal attainment and calculation of treatment success. The Tool is designed to be used by clinicians with varying levels of expertise in the field of neurological rehabilitation and post-stroke spasticity management, from those who are new to the field to those with many years of experience. A case study is presented in the Results Section of the article to illustrate the utility of the Tool in setting SMART treatment goals in the management of patients with post-stroke spasticity.

Botulinum toxin use in patients with post-stroke spasticity: a nationwide retrospective study from France.

Background: Current guidelines recommend intramuscular botulinum toxin type A (BoNT-A) injection as first-line treatment for spasticity, a frequent and impairing feature of various central nervous system (CNS) lesions such as stroke. Patients with spasticity commonly require BoNT-A injections once every 3 to 4 months. We conducted a nationwide, population-based, retrospective cohort study, using the French National Hospital Discharge Database (PMSI), to describe BoNT-A use for spasticity in clinical practice in France between 2014 and 2020. The PMSI database covers the whole French population, corresponding to over 66 million persons. Methods: We first searched the PMSI database for healthcare facility discharge of patients who received BoNT-A injections between 2014 and 2020, corresponding to the first set. For each BoNT-A-treated patient, we identified the medical condition for which BoNT-A may have been indicated. Another search of the PMSI database focused on patients admitted for acute stroke between 2014 and 2016 and their spasticity-related care pathway (second set). Overall, two subpopulations were analysed: 138,481 patients who received BoNT-A injections between 2014 and 2020, and 318,025 patients who survived a stroke event between 2014 and 2016 and were followed up until 2020. Results: Among the 138,481 BoNT-A-treated patients, 53.5% received only one or two BoNT-A injections. Most of these patients (N = 85,900; 62.0%) received BoNT-A because they had CNS lesions. The number of patients with CNS lesions who received ≥1 BoNT-A injection increased by a mean of 7.5% per year from 2014 to 2019, but decreased by 0.2% between 2019 and 2020, corresponding to the COVID-19 outbreak. In stroke survivors (N = 318,025), 10.7% were coded with post-stroke spasticity, 2.3% received ≥1 BoNT-A injection between 2014 and 2020, and only 0.8% received ≥3 injections within the 12 months following BoNT-A treatment initiation, i.e., once every 3 to 4 months. Conclusion: Our analysis of the exhaustive PMSI database showed a suboptimal implementation of BoNT-A treatment recommendations in France. BoNT-A treatment initiation and re-administration are low, particularly in patients with post-stroke spasticity. Further investigations may help explain this observation, and may target specific actions to improve spasticity-related care pathway.

Goal Attainment Scaling in rehabilitation: An educational review providing a comprehensive didactical tool box for implementing Goal Attainment Scaling.

CONTEXT: Goal Attainment Scaling (GAS) is a person-centered and collaborative approach, allowing to assess the effectiveness of an intervention on personally relevant goals. However, GAS is not a "scale" but a heterogeneous group of methodologies, including many variations and lack of consensus on high quality GAS. OBJECTIVE: The aim of this communication is to: 1. provide updated didactical information on GAS use in PRM practice and research; 2. increase awareness of GAS methodological challenges; 3. guide use of GAS as an integrated process of rehabilitation after goal setting and; 4. provide updated resources for self-directed learning and extensive supplemental material to increase knowledge and practical skills in GAS use. METHODS: Educational literature review about current GAS applications relevant to PRM fields. RESULTS: Practical advice is provided regarding clinical challenges in GAS: definition of 0 level, time-frame and means employed to attain the goal, dealing with unforeseen pattern of improvement, synthesizing the numerous significations of "SMART" goal acronym to guide best use of GAS, and thinking flexibility on the type of relevant goals that can be set. Challenges with GAS in rehabilitation research are presented in order to promote researcher's and reviewer's awareness on reliable use of GAS and encouraging best-use of GAS.

Feasibility of a serious game system including a tangible object for post stroke upper limb rehabilitation: a pilot randomized clinical study.

Introduction: Serious games can be used to provide intensive rehabilitation through attractive exercises as part of post-stroke rehabilitation. However, currently available commercial and serious games systems primarily train shoulder and elbow movements. These games lack the grasping and displacement components that are essential to improve upper limb function. For this reason, we developed a tabletop device that encompassed a serious game with a tangible object to rehabilitate combined reaching and displacement movements: the Ergotact system. Objectives: The aim of this pilot study was to assess the feasibility and the short-term effects of a training program using the Ergotact prototype in individuals with chronic stroke. Methods: Participants were assigned to one of two groups: a serious game training group (Ergotact) or a control training group (Self). Results: Twenty-eight individuals were included. Upper limb function increased after the Ergotact training program, although not statistically significantly, and the program did not induce pain or fatigue, demonstrating its safety. Conclusion: The Ergotact system for upper limb rehabilitation was well accepted and induced participant satisfaction. It complies with current recommendations for people with stroke to autonomously perform intensive active exercises in a fun context, in addition to conventional rehabilitation sessions with therapists. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03166020?term=NCT03166020&draw=2&rank=1, identifier NCT03166020.

Trends in Botulinum Toxin Use among Patients with Multiple Sclerosis: A Population-Based Study.

There are limited real-world data on the use of botulinum toxin type A (BoNT-A) in patients with multiple sclerosis (MS). Accordingly, this nationwide, population-based, retrospective cohort study aimed to describe BoNT-A treatment trends in patients with MS between 2014 and 2020 in France. This study extracted data from the French National Hospital Discharge Database (Programme de Médicalisation des Systèmes d'Information, PMSI) covering the entire French population. Among 105,206 patients coded with MS, we identified those who received ≥1 BoNT-A injection, administered within striated muscle for MS-related spasticity and/or within the detrusor smooth muscle for neurogenic detrusor overactivity (NDO). A total of 8427 patients (8.0%) received BoNT-A injections for spasticity, 52.9% of whom received ≥3 BoNT-A injections with 61.9% of the repeated injections administered every 3 to 6 months. A total of 2912 patients (2.8%) received BoNT-A injections for NDO, with a mean of 4.7 injections per patient. Most repeated BoNT-A injections within the detrusor smooth muscle (60.0%) were administered every 5 to 8 months. There were 585 patients (0.6%) who received both BoNT-A injections within striated muscle and the detrusor smooth muscle. Overall, our study highlights a broad range of BoNT-A treatment practices between 2014 and 2020 in patients with MS.

Goal-Setting in Multiple Sclerosis-Related Spasticity Treated with Botulinum Toxin: The GASEPTOX Study.

Spasticity is one of the most disabling symptoms in multiple sclerosis (MS). Botulinum toxin injection (BTI) is a first-line treatment for focal spasticity. There is a lack of evidence of a functional improvement following BTI in MS-related spasticity. To describe goal-setting for BTI in MS, and evaluate the degree of attainment, using goal attainment scaling (GAS) 4-to-6 weeks after injection session, a one-year multi-center retrospective observational study assessing goal-setting and achievement during BTI session in spastic patients with MS was set up. Following the GAS method, patients and their physicians set up to three goals and scored their achievement 4 to 6 weeks thereafter. Commonly used goals from three centers were combined into a standardized list and 125 single BTI sessions were analyzed. The most frequent goals regarded lower limb (LL) impairments (equinovarus foot, toe claw) or locomotion (stability, walking distance, clinging) and accounted for 89.1%, versus 10.9% for upper limb (UL), mostly for mild-to-moderate MS. Overall, goals were frequently achieved (85.77%) mainly when related to gait and mobility rather than hygiene and ease of care. This study gives an overview on the most frequent, relevant, and achievable goals to be set in real-life practice of BTI for spasticity management in MS.

A Restructured Hospital Into a One-Building Organization for COVID-19 Patients: A Resilient and Effective Response to the Pandemic.

The COVID-19 pandemic is a unique crisis challenging healthcare institutions as it rapidly overwhelmed hospitals due to a large influx of patients. This major event forced all the components of the healthcare systems to adapt and invent new workflows. Thus, our tertiary care hospital was reorganized entirely. During the cruising phase, additional staff was allocated to a one-building organization comprising an intensive care unit (ICU), an acute care unit, a physical medicine and rehabilitation unit, and a COVID-19 screening area. The transfer of patients from a ward to another was more efficient due to these organizations and pavilion structure. The observed mortality was low in the acute care ward, except in the palliative unit. No nosocomial infection with SARS-CoV-2 was reported in any other building of the hospital since this organization was set up. This type of one-building organization, integrating all the components for comprehensive patient care, seems to be the most appropriate response to pandemics.

Nutritional status in patients with advanced-stage multiple sclerosis.

INTRODUCTION: Motor and swallowing dysfunctions in multiple sclerosis (MS) unbalance calorie intake and energy expenditure, modifying nutritional status. Only one study has described nutritional status in MS patients at early disease stages (median Expanded Disability Status Scale [EDSS] = 3), but this has never been assessed in the most severe cases. The goal of the present study was to describe nutritional status in advanced-stage MS. METHODS: The study was a non-interventional retrospective analysis of a prospective registry. We reviewed medical files of consecutive MS patients admitted for annual follow-up in a physical and rehabilitation medicine unit between May 2016 and October 2018. Malnutrition for frail people, according to the French Health Authority (Haute Autorité de Santé [HAS]) definition, was our composite primary outcome criterion: body mass index (BMI) <21 kg/m2 and/or albumin<35 g/L. First, we performed a descriptive analysis of the nutritional status. Second, we studied the association between malnutrition and MS characteristics in univariate and multivariate analyses. RESULTS: A total of 163 patients with median EDSS = 8 [7; 8.5] were included. Ninety-three patients (57%) met HAS malnutrition criteria (36% with albumin <35 g/L, 31% with BMI <21 kg/m2 and 10% with both). Malnutrition was associated in univariate analysis with MS severity (EDSS ≥8.5, p = 0.0003), primary progressive type of MS (p = 0.01) and swallowing disorders (p = 0.002). Multivariate analysis showed that low disability status (EDSS <7) was the only independent (protective) factor associated with malnutrition (OR = 0.2, p = 0.03). CONCLUSIONS: Malnutrition is frequent in advanced stages of MS and is probably a key point for therapeutics, which has never been demonstrated previously. A standardized evaluation should be developed to improve nutritional therapeutic strategies in this population.

European expert consensus on improving patient selection for the management of disabling spasticity with intrathecal baclofen and/or botulinum toxin type A.

OBJECTIVE: To develop an algorithm for the selection of adults with disabling spasticity for treatment with intrathecal baclofen (ITB) and/or botulinum toxin type A (BoNT A). METHODS: A European Advisory Board of 4 neurologists and 4 rehabilitation specialists performed a literature review on ITB and BoNT A treatment for disabling spasticity. An online survey was sent to 125 physicians and 13 non-physician spasticity experts. Information on their current clinical practice and level of agreement on proposed selection criteria was used to inform algorithm design. Consensus was considered reached when ≥75% of respondents agreed or were neutral. RESULTS: A total of 79 experts from 17 countries completed the on-line survey (57%). Agreement was reached that patients with multi-segmental or generalized disabling spasticity refractory to oral drugs are the best candidates for ITB (96.1% consensus), while those with focal/segmental disabling spasticity are ideal candidates for BoNT A (98.7% consensus). In addition the following are good candidates for ITB (% consensus): bilateral disabling spasticity affecting lower limbs only (97.4%), bilateral (100%) or unilateral (90.9%) disabling spasticity affecting lower limbs and trunk, and unilateral or bilateral disabling spasticity affecting upper and lower extremities (96.1%). CONCLUSION: This algorithm will support the management of adult patients with disabling spasticity by aiding patient selection for ITB and/or BoNT A treatments.

Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT.

BACKGROUND: Commercial gaming systems are increasingly being used for stroke rehabilitation; however, their effect on upper-limb recovery versus compensation is unknown. OBJECTIVES: We aimed to compare the effect of upper-limb rehabilitation using interactive gaming (Nintendo Wii) with dose-matched conventional therapy on elbow extension (recovery) and forward trunk motion (compensation) in individuals with chronic stroke. Secondary aims were to compare the effect on (1) clinical tests of impairment and activity, pain and effort, and (2) trajectory kinematics. We also explored arm and trunk motion (acceleration) during Wii sessions to understand how participants performed movements during Wii gaming. METHODS: This single-centre, randomized controlled trial compared 12 hourly sessions over 4 weeks of upper-limb Wii therapy to conventional therapy. Outcomes were evaluated at baseline and 4 weeks. The change in elbow extension and trunk motion during a reaching task was evaluated by electromagnetic sensors. Secondary outcomes were change in Fugl-Meyer assessment, Box and Block test, Action Research Arm Test, Motor Activity Log, and Stroke Impact Scale scores. Arm and trunk acceleration during Wii therapy was evaluated by using inertial sensors. A healthy control group was included for reference data. RESULTS: Nineteen participants completed Wii therapy and 21 conventional therapy (mean [SD] time post-stroke 66.4 [57.2] months). The intervention and control groups did not differ in mean change in elbow extension angle (Wii: +4.5°, 95% confidence interval [CI] 0.1; 9.1; conventional therapy: +6.4°, 95%CI 0.6; 12.2) and forward trunk position (Wii: -3.3 cm, 95%CI -6.2;-0.4]; conventional therapy: -4.1 cm, 95%CI -6.6; -1.6) (effect size: elbow, d = 0.16, p = 0.61; trunk, d = 0.13, p = 0.65). Clinical scores improved similarly but to a small extent in both groups. The amount of arm but not trunk acceleration produced during Wii sessions increased with training. CONCLUSIONS: Supervised upper-limb gaming therapy induced similar recovery of elbow extension as conventional therapy and did not enhance the development of compensatory forward trunk movement in individuals with chronic stroke. More sessions may be necessary to induce greater improvements. CLINICALTRIALS: GOV: NCT01806883.

Single-session training on an ascending treadmill slope: effects on gait parameters in persons with stroke. A pilot study.

OBJECTIVE: Treadmill training with an upward incline could improve gait parameters altered in persons with stroke, especially lower limb flexion. This study aimed to determine the effects of a treadmill single-session training with a 10% upward incline on biomechanical gait parameters in persons with stroke. METHODS: Fifteen persons with stroke-related hemiparesis performed a 20-min treadmill training session with a 10% ascending incline in this interventional pilot study. Spatiotemporal, kinematic and kinetic parameters were evaluated, overground, with a tridimensional optoelectronic system, before the session, immediately after and after a 20-min rest period. RESULTS: The single-session training on a treadmill with a 10% incline has significantly increased hip flexion peak on the paretic side (39.8°± 8.1 in baseline to 42.7°± 8.6 after the session, P < 0.001, large effect size) and knee flexion peak on the paretic side (39.9°± 11.6 in baseline to 43.1°± 11.7 after the session, P = 0.004, large effect size). Gait speed, other spatiotemporal gait parameters and propulsion on the paretic side were also significantly increased (P < 0.05, all large effects size). These short-term changes were maintained after the break. CONCLUSIONS: A treadmill single-session training with a 10% upward incline induces biomechanical changes in people with stroke. The environmental constraints of this training could explain these biomechanical adaptations, concerning especially paretic hip and knee flexion.

Efficacy of incobotulinumtoxinA for the treatment of adult lower-limb post-stroke spasticity, including pes equinovarus.

BACKGROUND: Lower-limb spasticity can impair ambulation and gait, impacting quality of life. OBJECTIVES: This ancillary analysis of the TOWER study (NCT01603459) assessed the efficacy of incobotulinumtoxinA for lower-limb post-stroke spasticity including pes equinovarus. METHODS: Participants received escalating incobotulinumtoxinA doses (400-800U) across 3 injection cycles. Changes were compared for those treated in the lower limb (with/without upper-limb treatment) or the upper limb only or for participants treated or untreated for pes equinovarus. Outcome measures were those used in the seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment. RESULTS: Among 132/155 (85%) participants with post-stroke spasticity, in cycles 1, 2 and 3, 99, 119 and 121 participants received lower-limb treatment with mean (SD) total limb incobotulinumtoxinA doses of 189.2 (99.2), 257.1 (115.0) and 321.3 (129.2) U, respectively. Of these, 80, 105 and 107, respectively, were treated for pes equinovarus. The mean (SD) improvement in REPAS lower-limb score was greater with treatment in the lower limb versus the upper limb only: -1.6 (2.1) versus-0.4 (1.4); -1.9 (1.9) versus -0.6 (1.6); -2.2 (2.2) versus -1.0 (0.0) (P=0.0005, P=0.0133 and P=0.3581; analysis of covariance [ANCOVA], between-group differences) in cycles 1, 2 and 3, respectively. For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P=0.0099; ANCOVA). At the end of cycle 3, 42% of participants walked independently and 63% achieved 2 of 2 lower-limb treatment goals (baseline 23% and 34%, respectively). CONCLUSIONS: This study supports the efficacy of incobotulinumtoxinA for treatment of pes equinovarus and other patterns of lower-limb post-stroke spasticity.

Improving Health of People With Multiple Sclerosis From a Multicenter Randomized Controlled Study in Parallel Groups: Preliminary Results on the Efficacy of a Mindfulness Intervention and Intention Implementation Associated With a Physical Activity Program.

Objectives: The objective of this study is to investigate the efficacy of psychological Interventions - Mindfulness or Implementation Intention - associated with a Physical Activity program, delivered via internet, in reducing Multiple Sclerosis symptoms. Method: Thirty-five adults were randomly assigned to one of the three groups: a Mindfulness-Based Intervention group (N = 12), Implementation Intention group (N = 11), and a Control Group (N = 12). All the groups received the same Physical Activity program. The Mindfulness condition group received daily training in the form of pre-recorded sessions while the Implementation group elaborated their specific plans once a week. Mobility, fatigue, and the impact of the disease on the patient's life were measured. Two measurement times are carried out in pre-post intervention, at baseline and after eight weeks. Results: Overall, after 8 weeks intervention, results show that there was a significant increase in Walking distance in the three groups. In addition, the within-group analysis showed a statistically significant improvement between pre and post intervention on the physical component of the Disease Impact scale in the Implementation Intention group (p = 0.023) with large effect size, in the Mindfulness-Based Intervention group (p = 0.008) with a medium effect size and in the control group (p = 0.028) with small effect size. In the Implementation Intention group, all physical, psychosocial and cognitive Fatigue Impact subscales scores decreased significantly (p = 0.022, p = 0.023, and p = 0.012, respectively) and the physical component was statistically and negatively correlated (r = -0.745; p = 0.008) when Implementation Intention group practice a mild to moderate physical activity. In the Mindfulness-Based Intervention group, the physical component (MFIS) showed a statistically significant improvement (p = 0.028) but no correlation with moderate-to-vigorous physical activity (MVPA); the control group outcomes did not reveal any significant change. Conclusion: The results of this study are very encouraging and show the feasibility of Mindfulness interventions associated with physical activity to improve the health of people with MS. Further study should assess Mindfulness interventions tailored to MS condition and using both hedonic and eudemonic measures of happiness.