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1.
Toxins (Basel) ; 16(1)2023 12 29.
Article in English | MEDLINE | ID: mdl-38251237

ABSTRACT

A strong correlation has been reported between patient-reported quality of life (QoL) and the investigator-rated Disability Assessment Scale (DAS) in patients with spasticity. The current analysis evaluates the effect of incobotulinumtoxinA on QoL-related outcomes (limb position abnormality, as well as dressing- and hygiene-related disability, measured with the DAS) in adults with upper limb spasticity, using pooled data from six studies. Separate analyses for each DAS domain were performed using data from patients with disabilities for that domain (DAS score ≥1). Results showed that a significantly greater proportion of incobotulinumtoxinA-treated compared with placebo-treated patients achieved a ≥1-point reduction from baseline in each of the DAS domains (improvement) 4 weeks after the first injection. The benefits of incobotulinumtoxinA were observed regardless of the baseline severity of DAS impairment and of the time elapsed since stroke. The effects of incobotulinumtoxinA 4 weeks after injection were maintained or enhanced over multiple injection cycles for all three DAS domains, supporting the use of repeated injection cycles to provide sustained QoL benefit. IncobotulinumtoxinA represents an important treatment option to achieve better QoL-related outcomes for patients with upper limb spasticity, irrespective of the duration of their condition.


Subject(s)
Botulinum Toxins, Type A , Limb Deformities, Congenital , Adult , Humans , Quality of Life , Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy
2.
J Rehabil Med ; 54: jrm00303, 2022 Aug 24.
Article in English | MEDLINE | ID: mdl-35844200

ABSTRACT

OBJECTIVE: Stroke is associated with a high risk of death and cardiovascular events. Rehabilitation therapy is critical for functional recovery, to reduce hospital readmissions, all-cause and cardiovascular mortality, and stroke recurrence (long-term outcomes). Post-stroke spasticity may prevent effective recovery by restricting mobility. AbobotulinumtoxinA is an adjunctive therapy to physical therapy for post-stroke spasticity, but its long-term effects are unknown. The objective was to model the long-term clinical and economic outcomes of abobotulinumtoxinA for post-stroke spasticity. METHODS: Effects of abobotulinumtoxinA on treating post-stroke spasticity and evidence linking functional outcomes with long-term outcomes were collected in a focused literature review. A model was developed to estimate health benefits on long-term outcomes, direct medical costs, life- and qualityadjusted life-years for abobotulinumtoxinA injections plus rehabilitation therapy compared with rehabilitation therapy alone, from a UK perspective over a 10-year time-period. RESULTS: AbobotulinumtoxinA + rehabilitation therapy led to a risk reduction of 8.8% for all-cause mortality, and an increase of 13% in life-years and 59% in quality-adjusted life-years compared with rehabilitation therapy alone. AbobotulinumtoxinA + rehabilitation therapy was considered cost-effective compared with rehabilitation therapy alone (incremental cost-effectiveness ratio: £24,602). CONCLUSION: AbobotulinumtoxinA + rehabilitation therapy may improve long-term outcomes, including post-stroke survival, while being cost-effective for the treatment of post-stroke spasticity.


Subject(s)
Botulinum Toxins, Type A , Stroke , Humans , Muscle Spasticity/drug therapy , Muscle Spasticity/etiology , Stroke/drug therapy , Treatment Outcome
3.
Healthcare (Basel) ; 10(4)2022 Apr 10.
Article in English | MEDLINE | ID: mdl-35455881

ABSTRACT

This preliminary randomized clinical trial explores the efficacy of task-oriented electromyography (EMG)-triggered multichannel functional electrical stimulation (EMG-MES) compared to single-channel cyclic neuromuscular electrical stimulation (cNMES) on regaining control of voluntary movements (CVM) and the ability to execute arm-hand-activities in subacute stroke patients with moderate arm paresis. Twelve ischemic stroke patients (Fugl-Meyer Assessment Arm Section (FMA-AS) score: 19-47) with comparable demographics were block-randomized to receive 15 sessions of cNMES or EMG-MES over three weeks additionally to a conventional neurorehabilitation program including task-oriented arm training. FMA-AS, Box-and-Block Test (BBT), and Stroke-Impact-Scale (SIS) were recorded at baseline and follow-up. All participants demonstrated significant improvement in FMA-AS and BBT. Participants treated with EMG-MES had a higher mean gain in FMA-AS than those treated with cNMES. In the SIS daily activities domain, both groups improved non-significantly; participants in the EMG-MES group had higher improvement in arm-hand use and stroke recovery. EMG-MES treatment demonstrated a higher gain of CVM and self-reported daily activities, arm-hand use, and stroke recovery compared to cNMES treatment of the wrist only. The protocol of this proof-of-concept study seems robust enough to be used in a larger trial to confirm these preliminary findings.

4.
Disabil Rehabil ; 44(26): 8515-8523, 2022 12.
Article in English | MEDLINE | ID: mdl-34982603

ABSTRACT

PURPOSE: The impact of botulinum neurotoxin-A (BoNT-A) on functional outcomes when managing focal muscle spasticity remains unclear. It is possible that randomised controlled trial (RCT) design and/or reporting may be a contributing factor. The objective of this review was to determine the extent to which RCTs evaluating functional outcomes following BoNT-A align with focal spasticity guidelines. MATERIALS AND METHODS: RCTs published from 2010 were included if they targeted focal spasticity, included BoNT-A, randomised a physical intervention to the upper/lower limb, or the primary outcome(s) related to the activity/participation domains of the International Classification of Functioning, Disability, and Health. Data extraction and quality appraisal using the Modified PEDro and Modified McMasters Tool were performed independently by two reviewers. General research practices were also extracted such as compliance with therapy reporting guidelines. RESULTS: Fifty-two RCTs were eligible. Individualised goal setting was uncommon (25%). Six studies (11.5%) included multi-disciplinary management, and five (9.6%) included patient/caregiver education. Four studies (7.7%) measured outcomes beyond 6 months. The Median Modified PEDro score was 11/15. CONCLUSIONS: Alignment with focal spasticity guidelines in RCTs was generally low. Our understanding of the impact of focal spasticity management on functional outcomes may be improved if RCT design aligned more closely with guideline recommendations.IMPLICATIONS FOR REHABILITATIONThe influence of BoNT-A on improved functional outcomes is yet to be determined.Individualised goal setting with a multi-disciplinary team is uncommon in an RCT design, despite it being a key guideline recommendation.Given the long-term nature of spasticity management, guidelines recommend short as well as long-term reviews following intervention however RCTs rarely assess beyond 6 months.


Subject(s)
Botulinum Toxins, Type A , Neuromuscular Agents , Humans , Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy , Upper Extremity , Caregivers , Randomized Controlled Trials as Topic
5.
Disabil Rehabil ; 44(8): 1367-1373, 2022 04.
Article in English | MEDLINE | ID: mdl-32805151

ABSTRACT

PURPOSE: To map spasticity-related goals using the International Classification of Functioning, Disability and Health (ICF) linking rules, and review goal syntax to direct future goal setting. MATERIALS AND METHODS: 1633 treatment goals, set during the TOWER study, were linked to the ICF framework and EQ-5D domains. Goals were mapped independently by two investigators with expertise in ICF linking rules. RESULTS: In total, 1630 (99.8%) goals could be mapped to the ICF (inter-rater agreement on the main ICF category 96.1%). Most goals (80.2%) were mapped to a single ICF category and were related to activities/participation (54.9%). 170 (10.4%) goals were related to general tasks and activities, such as positioning, stretching, and strengthening. In total, 1072 goals (65.6%) mapped to the EQ-5D domains (inter-rater agreement 90.8%). Analysis of the goal syntax highlighted the need to include a verb in patient-centered goals to direct active behavior. CONCLUSIONS: The ICF offers a broad framework for setting patient-centered, easily understandable goals for patients with spasticity, including goals related to (guided) self-management activities. This analysis sheds new light on patient needs and could direct future goal-driven botulinum toxin spasticity treatment focused on enabling patients to better manage activity limitations imposed by their body function impairments.Trial registration: NCT01603459 registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01603459).Implications for RehabilitationThe ICF offers a broad framework for setting patient-centered, easily understandable goals for patients with spasticity.ICF domains that include general tasks and demands can be used to establish goals relating to (guided) self-management of spasticity.An ICF-based goal-setting framework may increase the comparability of clinical data across studies.


Subject(s)
Botulinum Toxins, Type A , Disabled Persons , Botulinum Toxins, Type A/therapeutic use , Disability Evaluation , Goals , Humans , International Classification of Functioning, Disability and Health , Muscle Spasticity/drug therapy
6.
Disabil Rehabil ; 44(4): 509-519, 2022 Feb.
Article in English | MEDLINE | ID: mdl-32503375

ABSTRACT

OBJECTIVE: To identify and appraise the existing clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of adult and paediatric focal spasticity to generate a single synthesized guideline. METHODS: Systematic review of 12 electronic databases. Clinical practice guidelines, consensus statements and Cochrane systematic reviews for focal spasticity in adults and children. Included studies were appraised according to the AGREE II criteria. RESULTS: A total of 25 papers were included in this review, comprising 12 clinical practice guidelines, nine consensus statements and four Cochrane systematic reviews. The areas most strongly endorsed were: (1) management to be provided by a multi-disciplinary team, (2) therapy should be goal-directed, (3) goals to be developed in conjunction with the patient and family, and (4) importance of follow-up evaluations. There was a greater focus on activity outcomes and classification in the paediatric papers. The guidelines varied considerably in their quality, with AGREE II scores ranging from 52.8 to 97.1%. CONCLUSIONS: This systematic review has synthesized the key elements regarding principles of focal spasticity management, outcome measures, physical interventions and educational recommendations into a single, readily applied guideline available for clinical use. Despite considerable variability in the quality of the guidelines, several strong themes emerged.Implications for rehabilitationFocal spasticity management should be multi-disciplinary, patient-centred and goal-directed.Routine measurement of impairment and activity are strongly endorsed.Botulinum toxin A injection should only be provided as part of an integrated approach to focal spasticity management.


Subject(s)
Muscle Spasticity , Adult , Child , Consensus , Humans , Muscle Spasticity/drug therapy
7.
J Rehabil Med ; 54: jrm00244, 2022 Jan 03.
Article in English | MEDLINE | ID: mdl-34726763

ABSTRACT

OBJECTIVE: To describe the development of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D) and its sensitivity to clinical change (responsiveness). DESIGN: Multicentre, prospective, longitudinal cohort study at 8 UK sites (NCT03442660). PATIENTS: Adults (n = 104) undergoing focal treatment of upper limb spasticity. METHODS: No condition-specific health-related quality of life tool is available for upper-limb spasticity of any aetiology. The SQoL-6D was developed to fulfil this need, designed to complement the Upper Limb Spasticity Index (which incorporates the Goal Attainment Scaling evaluation of upper limb spasticity [GASeous] tool) with targeted standardised measures. The 6 dimensions of the SQoL-6D (score range 0-4) map onto common treatment goal areas identified in upper-limb spasticity studies. A Total score (0-100) provides overall spasticity-related health status. To assess responsiveness, the SQoL-6D, Global Assessment of Benefit scale and "GASeous" were administered at enrolment and 8 weeks. RESULTS: Significant differences in mean SQoL-6D Total score change and effect sizes across patients rating "some benefit" (0.51) and "great benefit" (0.88) supported responsiveness. CONCLUSION: The SQoL-6D is a promising new measure of health status in upper limb spasticity, that enables systematic assessment of the impact of this condition in relation to patients' priority treatment goals. A psychometric evaluation of SQoL-6D is presented separately.


Subject(s)
Botulinum Toxins, Type A , Neuromuscular Agents , Stroke , Adult , Humans , Longitudinal Studies , Muscle Spasticity/etiology , Prospective Studies , Quality of Life , Treatment Outcome , Upper Extremity
8.
J Rehabil Med ; 54: jrm00243, 2022 Jan 03.
Article in English | MEDLINE | ID: mdl-34726764

ABSTRACT

OBJECTIVE: Psychometric evaluation of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D). DESIGN: A clinimetric evaluation conducted in a multicentre, prospective, longitudinal cohort study at 8 UK sites. PATIENTS: Adult patients (n=104) undergoing focal treatment of upper-limb spasticity. METHODS: The SQoL-6D was administered in the clinic at enrolment and at 8 weeks, then 1-4 days later at home to assess test-retest reliability. RESULTS: The SQoL-6D demonstrated adequate construct validity and unidimensionality of the scale, allowing the calculation of a Total score. Cronbach's alpha (0.74) supported the internal consistency reliability, while the intraclass correlation coefficient supported test-retest reliability (0.82). Correlation coefficients with established instruments supported convergent validity, while significant differences between known-groups (of differing clinical severity) in SQoL-6D Total score confirmed its sensitivity to both cross-sectional and longitudinal differences. CONCLUSION: The SQoL-6D is a promising new measure to assess health status for patients with upper-limb spasticity of any aetiology. Further investigation and exploration of the allocation of weights to convert the SQoL-6D to a health-related quality of life utility index, are required.


Subject(s)
Quality of Life , Upper Extremity , Adult , Cross-Sectional Studies , Humans , Longitudinal Studies , Prospective Studies , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
9.
Neurol Res Pract ; 3(1): 23, 2021 May 04.
Article in English | MEDLINE | ID: mdl-33941289

ABSTRACT

INTRODUCTION: Neurogenic dysphagia defines swallowing disorders caused by diseases of the central and peripheral nervous system, neuromuscular transmission, or muscles. Neurogenic dysphagia is one of the most common and at the same time most dangerous symptoms of many neurological diseases. Its most important sequelae include aspiration pneumonia, malnutrition and dehydration, and affected patients more often require long-term care and are exposed to an increased mortality. Based on a systematic pubmed research of related original papers, review articles, international guidelines and surveys about the diagnostics and treatment of neurogenic dysphagia, a consensus process was initiated, which included dysphagia experts from 27 medical societies. RECOMMENDATIONS: This guideline consists of 53 recommendations covering in its first part the whole diagnostic spectrum from the dysphagia specific medical history, initial dysphagia screening and clinical assessment, to more refined instrumental procedures, such as flexible endoscopic evaluation of swallowing, the videofluoroscopic swallowing study and high-resolution manometry. In addition, specific clinical scenarios are captured, among others the management of patients with nasogastric and tracheotomy tubes. The second part of this guideline is dedicated to the treatment of neurogenic dysphagia. Apart from dietary interventions and behavioral swallowing treatment, interventions to improve oral hygiene, pharmacological treatment options, different modalities of neurostimulation as well as minimally invasive and surgical therapies are dealt with. CONCLUSIONS: The diagnosis and treatment of neurogenic dysphagia is challenging and requires a joined effort of different medical professions. While the evidence supporting the implementation of dysphagia screening is rather convincing, further trials are needed to improve the quality of evidence for more refined methods of dysphagia diagnostics and, in particular, the different treatment options of neurogenic dysphagia. The present article is an abridged and translated version of the guideline recently published online ( https://www.awmf.org/uploads/tx_szleitlinien/030-111l_Neurogene-Dysphagie_2020-05.pdf ).

10.
J Neural Transm (Vienna) ; 128(3): 321-335, 2021 03.
Article in English | MEDLINE | ID: mdl-33635442

ABSTRACT

Botulinum toxin (BT) therapy is a complex and highly individualised therapy defined by treatment algorithms and injection schemes describing its target muscles and their dosing. Various consensus guidelines have tried to standardise and to improve BT therapy. We wanted to update and improve consensus guidelines by: (1) Acknowledging recent advances of treatment algorithms. (2) Basing dosing tables on statistical analyses of real-life treatment data of 1831 BT injections in 36 different target muscles in 420 dystonia patients and 1593 BT injections in 31 different target muscles in 240 spasticity patients. (3) Providing more detailed dosing data including typical doses, dose variabilities, and dosing limits. (4) Including total doses and target muscle selections for typical clinical entities thus adapting dosing to different aetiologies and pathophysiologies. (5) In addition, providing a brief and concise review of the clinical entity treated together with general principles of its BT therapy. For this, we collaborated with IAB-Interdisciplinary Working Group for Movement Disorders which invited an international panel of experts for the support.


Subject(s)
Botulinum Toxins, Type A , Botulinum Toxins , Dystonia , Dystonic Disorders , Algorithms , Dystonia/drug therapy , Dystonic Disorders/drug therapy , Humans , Muscle Spasticity/drug therapy
11.
J Rehabil Med ; 53(2): jrm00157, 2021 02 24.
Article in English | MEDLINE | ID: mdl-33616192

ABSTRACT

OBJECTIVE: To assess the longitudinal effects of integrated spasticity management incorporating repeated cycles of botulinum toxin A type A (BoNT-A) over 2 years. METHODS: The Upper Limb International Spasticity study was a prospective, observational, cohort study following adult patients over 2 years of integrated upper-limb spasticity management including repeat botulinum toxin (BoNT-A) treatment (any commercially-available product). RESULTS: A total of 1,004 participants from 14 countries were enrolled, of which 953 underwent ≥ 1 BoNT-A injection cycle (median 4 cycles) and had ≥ 1 goal attainment scaling assessment. Most participants (55.9-64.6% across cycles 1-6) saw a therapist after BoNT-A treatment; the most frequent therapy intervention was passive stretch (70.1-79.8% across cycles 1-6). Patients achieved their goals as expected over repeated cycles; mean cumulated goal attainment scaling T-score at 2 years was 49.5 (49.1, 49.9). Mean goal attainment scaling change scores of ≥ 10 were maintained across up to 7 cycles. Higher rates of goal achievement were seen for primary goals related to passive vs active function (86.6% vs 71.4% achievement). Standardized measures of spasticity, pain, involuntary movements, active and passive function improved significantly over the study. CONCLUSION: This large, international study provides evidence for benefit of repeated cycles of BoNT-A, over 2 years captured through person-centred goal attainment and standardized measures.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy , Upper Extremity/physiopathology , Botulinum Toxins, Type A/pharmacology , Cohort Studies , Female , Humans , Longitudinal Studies , Male , Middle Aged , Neuromuscular Agents/therapeutic use , Prospective Studies , Treatment Outcome
12.
J Rehabil Med ; 53(1): jrm00133, 2021 Jan 01.
Article in English | MEDLINE | ID: mdl-33206198

ABSTRACT

OBJECTIVE: To describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study. METHODS: ULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observation-al, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule. RESULTS: A total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2-50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p < 0.001) were seen between the commercially-available botulinum toxin-A agents. CONCLUSION: The results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy , Stroke Rehabilitation/methods , Stroke/complications , Upper Extremity/physiopathology , Female , Humans , Longitudinal Studies , Male , Middle Aged , Treatment Outcome
13.
Health Qual Life Outcomes ; 18(1): 51, 2020 Mar 04.
Article in English | MEDLINE | ID: mdl-32131842

ABSTRACT

BACKGROUND: We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. METHODS: In this exploratory trial, subjects (N = 155; 18-80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks' follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. RESULTS: The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with 'improvement' was greater than that with 'worsening' for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as 'normal' increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of 'severe impairment'. CONCLUSION: These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Muscle Spasticity/drug therapy , Neuromuscular Agents/administration & dosage , Quality of Life , Adolescent , Adult , Aged , Dose-Response Relationship, Drug , Extremities/physiopathology , Female , Humans , Injections , Male , Middle Aged , Prospective Studies , Surveys and Questionnaires
14.
Orphanet J Rare Dis ; 15(1): 64, 2020 03 04.
Article in English | MEDLINE | ID: mdl-32131864

ABSTRACT

BACKGROUND: Hereditary spastic paraplegia (HSP) is a group of inherited disorders characterized by progressive spastic paresis of the lower limbs. Treatment is often focused on reducing spasticity and its physical consequences. To better address individual patients' needs, we investigated a broad range of experienced complaints, activity limitations, and loss of motor capacities in pure HSP. In addition, we aimed to identify patient characteristics that are associated with increased fall risk and/or reduced walking capacity. METHODS: We developed and distributed an HSP-specific online questionnaire in the Netherlands. A total of 109 out of 166 questionnaires returned by participants with pure HSP were analyzed. RESULTS: Participants experienced the greatest burden from muscle stiffness and limited standing and walking activities, while 72% reported leg and/or back pain. Thirty-five and 46% reported to use walking aids (e.g. crutches) indoors and outdoors, respectively; 57% reported a fall incidence of at least twice a year ('fallers'); in 51% a fall had led to an injury at least once; and 73% reported fear of falling. Duration of spasticity and incapacity to rise from the floor were positively associated with being a 'faller', whereas non-neurological comorbidity and wheelchair use were negatively associated. Higher age, experienced gait problems, not being able to stand for 10 min, and incapacity to open a heavy door showed a negative association with being a 'walker without aids' (> 500 m). CONCLUSIONS: Our results emphasize the large impact of spastic paraparesis on the lives of people with pure HSP and contribute to a better understanding of possible targets for rehabilitation.


Subject(s)
Spastic Paraplegia, Hereditary , Accidental Falls , Fear , Humans , Internet , Netherlands , Surveys and Questionnaires
15.
Front Neurol ; 11: 104, 2020.
Article in English | MEDLINE | ID: mdl-32184753

ABSTRACT

Background: Recent studies of botulinum toxin for post-stroke spasticity indicate potential benefits of early treatment (i. e., first 6 months) in terms of developing hypertonicity, pain and passive function limitations. This non-interventional, longitudinal study aimed to assess the impact of disease duration on the effectiveness of abobotulinumtoxinA treatment for upper limb spasticity. Methods: The early-BIRD study (NCT01840475) was conducted between February 2013 and 2018 in 43 centers across Germany, France, Austria, Netherlands and Switzerland. Adult patients with post-stroke upper limb spasticity undergoing routine abobotulinumtoxinA treatment were followed for up to four treatment cycles. Patients were categorized by time from stroke event to first botulinum toxin-A treatment in the study (as defined by the 1st and 3rd quartiles time distribution) into early-, medium- and late- start groups. We hypothesized that the early-start group would show a larger benefit (decrease) as assessed by the modified Ashworth scale (MAS, primary endpoint) on elbow plus wrist flexors compared with the late-start group. Results: Of the 303 patients enrolled, 292 (96.4%) received ≥1 treatment and 186 (61.4%) received 4 injection cycles and completed the study. Patients in all groups showed a reduction in MAS scores from baseline over the consecutive injection visits (i.e., at end of each cycle). Although reductions in MAS scores descriptively favored the early treatment group, the difference compared to the late group did not reach statistical significance at the last study visit (ANCOVA: difference in adjusted means of 0.15, p = 0.546). Conclusions: In this observational, routine-practice study, patients in all groups displayed a benefit from abobotulinumtoxinA treatment, supporting the effectiveness of treatment for patients at various disease stages. Although the data revealed some trends in favor of early vs. late treatment, we did not find strong evidence for a significant benefit of early vs. late start of treatment in terms of reduction in MAS scores.

16.
Clin Ther ; 41(11): 2321-2330.e4, 2019 11.
Article in English | MEDLINE | ID: mdl-31607560

ABSTRACT

PURPOSE: Our purpose was to determine satisfaction and confidence of the Ixcellence Network training program on health care practitioners using botulinum toxin A (BoNT-A) for neurologic disorders, including spastic paresis and cervical dystonia. METHODS: The Ixcellence Network training program was designed by a scientific committee of 6 experts and then tested at centers in Europe, and Latin America. The training, provided by 16 experienced neurologists and rehabilitation specialists, consisted of theoretic and practical sessions that covered the different stages of the patient's journey from diagnosis to tailored treatment and rehabilitation. Trainees' feedback and the impact on participants' practice were evaluated by 2 individual questionnaires, at the end of the session (T0) and at 6 months (T6). Trainers' feedback was also collected through an individual questionnaire. FINDINGS: Between September 2012 and December 2017, 728 trained physicians participated in training programs with 48%, 23%, and 29% of attendees participating in training sessions dedicated to adult spastic paresis, child spastic paresis, and cervical dystonia, respectively. At T0, 93% of attendees thought that they had been given new information and 90% thought that the training would change their daily practice. This was confirmed at T6 by 93% of respondents. Trainees were highly satisfied with the program, in particular with the practical sessions. Trainers expectations were met for attendees' level of expertise, motivation, language, and participation. IMPLICATIONS: In this descriptive study, we show that the Ixcellence Network program represents a new educational approach to promote consistency in care practices and dissemination of expertise on the use of BoNT-A for neurologic disorders.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Education, Medical, Continuing , Muscle Spasticity/therapy , Paresis/therapy , Torticollis/therapy , Europe , Humans , Personal Satisfaction , Surveys and Questionnaires
17.
J Occup Environ Med ; 60(11): e618-e624, 2018 11.
Article in English | MEDLINE | ID: mdl-30095532

ABSTRACT

OBJECTIVES: The main goal of this study was to compare the employment needs experienced by people with different chronic health conditions and in different welfare systems. METHODS: A total of 688 participants with six chronic health conditions were collected in nine countries representing four welfare systems in Europe (Continental, Mediterranean, Postcommunist, and Scandinavian). RESULTS: Raising awareness of what is to live with a chronic health condition in the workplace was the area perceived as more favorable. The types of employment needs were different across the social welfare systems but did not vary among the different chronic health conditions groups. CONCLUSION: Although diverse, there appear to be some common needs transversal to the working experience of people with chronic health problems. Actions to improve the employability of people with chronic health conditions should be tailored to each welfare system.


Subject(s)
Chronic Disease , Employment , Social Welfare , Adult , Europe , Female , Humans , Male , Middle Aged , Needs Assessment , Surveys and Questionnaires
18.
Article in English | MEDLINE | ID: mdl-29673231

ABSTRACT

Background: Persons with chronic diseases (PwCDs) often experience work-related problems, and innovative actions to improve their participation in the labor market are needed. In the frame of the European (EU) Pathways Project, the aim of the study is to compare existing strategies (policies, systems, and services) for professional (re-)integration of PwCDs and mental health conditions available at both European and national level between different European welfare models: Scandinavian, Continental, Anglo-Saxon, Mediterranean, and “Post-Communist”. Method: The European strategies were identified by an overview of relevant academic and grey literature searched through Medline and internet searches, while national strategies were explored through questionnaires and in-depth interviews with national relevant stakeholders. Results: The mapping of existing strategies revealed that, both at European and national level, PwCDs are often considered as part of the group of “persons with disabilities” and only in this case they can receive employment support. European countries put in place actions to support greater labor market participation, but these differ from country to country. Conclusion: Strategies targeting “persons with disabilities” do not necessarily address all the needs of persons with chronic diseases. Countries should consider the importance of employment for all to achieve smart, sustainable, and inclusive growth.


Subject(s)
Chronic Disease , Disabled Persons , Employment , Models, Theoretical , Social Welfare , Europe , Humans , Policy , Surveys and Questionnaires
19.
Article in English | MEDLINE | ID: mdl-29695093

ABSTRACT

(1) Purpose: This systematic review aims to assess the effectiveness of strategies used in the professional (re)integration of persons with mental disorders (MD) in European countries; (2) Methods: We conducted a search for scientific publications available in relevant electronic databases (Medline, PsycINFO, CDR-HTA, CDR-DARE, and Cochrane Library). The present study collected evidence on the effectiveness, from 2011 to 2016, of employment strategies for persons with MDs; (3) Results: A total of 18 studies were included, representing 5216 participants (aged 18⁻65, mean age of 38.5 years old) from 7 countries. Job access programs demonstrated effectiveness in four out of six studies. Return to work (RTW) interventions showed significant positive results in two studies, while four studies did not refer to effectiveness. There were inconsistent results in another four studies; (4) Conclusions: Our findings highlight the complexities of the implementation of employment strategies (job access and return to work). Job access strategies seem to improve employment outcomes. The effectiveness of return to work strategies remains unclear. The involvement and commitment of physicians, employment specialists, and employers, and employees capacity for self-care seem decisive for employment re-integration success. Further analyses are needed to assess the cost-effectiveness of these interventions and corroborate our results, with longer follow-ups.


Subject(s)
Employment/statistics & numerical data , Mental Disorders , Rehabilitation, Vocational , Cost-Benefit Analysis , Employment/economics , Europe , Humans , Mental Disorders/economics , Mental Disorders/epidemiology , Rehabilitation, Vocational/economics
20.
Article in English | MEDLINE | ID: mdl-29562715

ABSTRACT

Due to low employment rates associated to chronic conditions in Europe, it is essential to foster effective integration and re-integration into work strategies. The objective of this systematic review is to summarize the evidence on the effectiveness of strategies for integration and re-integration to work for persons with chronic diseases or with musculoskeletal disorders, implemented in Europe in the past five years. A systematic search was conducted in MedLine, PsycINFO, CDR-HTA, CDR-DARE and Cochrane Systematic Reviews. Overall, 32 relevant publications were identified. Of these, 21 were considered eligible after a methodological assessment and included. Positive changes in employment status, return to work and sick leave outcomes were achieved with graded sickness-absence certificates, part-time sick leave, early ergonomic interventions for back pain, disability evaluation followed by information and advice, and with multidisciplinary, coordinated and tailored return to work interventions. Additionally, a positive association between the co-existence of active labour market policies to promote employment and passive support measures (e.g., pensions or benefits) and the probability of finding a job was observed. Research on the evaluation of the effectiveness of strategies targeting integration and re-integration into work for persons with chronic health conditions needs, however, to be improved and strengthened.


Subject(s)
Chronic Disease , Return to Work , Disability Evaluation , Europe , Humans , Sick Leave
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