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1.
Arch Phys Med Rehabil ; 102(6): 1067-1074, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33548208

RESUMEN

OBJECTIVE: To determine the benefits associated with brief inpatient rehabilitation for coronavirus 2019 (COVID-19) patients. DESIGN: Retrospective chart review. SETTING: A newly created specialized rehabilitation unit in a tertiary care medical center. PARTICIPANTS: Consecutive sample of patients (N=100) with COVID-19 infection admitted to rehabilitation. INTERVENTION: Inpatient rehabilitation for postacute care COVID-19 patients. MAIN OUTCOME MEASURES: Measurements at admission and discharge comprised a Barthel Activities of Daily Living Index (including baseline value before COVID-19 infection), time to perform 10 sit-to-stands with associated cardiorespiratory changes, and grip strength (dynamometry). Correlations between these outcomes and the time spent in the intensive care unit (ICU) were explored. RESULTS: Upon admission to rehabilitation, 66% of the patients were men, the age was 66±22 years, mean delay from symptom onset was 20.4±10.0 days, body mass index was 26.0±5.4 kg/m2, 49% had hypertension, 29% had diabetes, and 26% had more than 50% pulmonary damage on computed tomographic scans. The mean length of rehabilitation stay was 9.8±5.6 days. From admission to discharge, the Barthel index increased from 77.3±26.7 to 88.8±24.5 (P<.001), without recovering baseline values (94.5±16.2; P<.001). There was a 37% improvement in sit-to-stand frequency (0.27±0.16 to 0.37±0.16 Hz; P<.001), a 13% decrease in post-test respiratory rate (30.7±12.6 to 26.6±6.1; P=.03), and a 15% increase in grip strength (18.1±9.2 to 20.9±8.9 kg; P<.001). At both admission and discharge, Barthel score correlated with grip strength (ρ=0.39-0.66; P<.01), which negatively correlated with time spent in the ICU (ρ=-0.57 to -0.49; P<.05). CONCLUSIONS: Inpatient rehabilitation for COVID-19 patients was associated with substantial motor, respiratory, and functional improvement, especially in severe cases, although there remained mild persistent autonomy loss upon discharge. After acute stages, COVID-19, primarily a respiratory disease, might convert into a motor impairment correlated with the time spent in intensive care.


Asunto(s)
COVID-19/rehabilitación , Cuidados Críticos/métodos , Pacientes Internos , Pandemias , Recuperación de la Función , Actividades Cotidianas , Anciano , COVID-19/epidemiología , Femenino , Humanos , Masculino , Estudios Retrospectivos , SARS-CoV-2
2.
J Neural Transm (Vienna) ; 127(12): 1619-1629, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-33106968

RESUMEN

The aim of this study in patients with post-stroke lower limb spasticity (PSLLS) was to evaluate the relationship between time of onabotulinumtoxinA treatment relative to stroke and efficacy outcomes. This was a phase 3, international, multicenter, randomized, 12-week, double-blind study, followed by a repeated treatment, open-label extension. Patients were aged 18-85 years with PSLLS (Modified Ashworth Scale [MAS] ≥ 3) of the ankle with the most recent stroke occurring ≥ 3 months before screening. Patients (double-blind phase) were randomized (n = 468) to onabotulinumtoxinA 300-400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and ≤ 100 U, optional lower limb muscles (flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, and rectus femoris]) or placebo. Primary endpoint: MAS change from baseline (average score of weeks 4 and 6). Secondary endpoints: physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12). When stratified by time since stroke (≤ 24 months, n = 153; > 24 months, n = 315, post hoc), patients treated ≤ 24 months post-stroke experienced greater improvements from baseline versus placebo in MAS (- 0.31 vs - 0.17), CGI (0.49 vs 0.12), and passive GAS scores (week 12, 0.37 vs 0.26). A ≥ - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04). OnabotulinumtoxinA 300-400 U was well tolerated, with no new safety findings.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Accidente Cerebrovascular , Adulto , Toxinas Botulínicas Tipo A/uso terapéutico , Método Doble Ciego , Humanos , Extremidad Inferior , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Fármacos Neuromusculares/uso terapéutico , Reflejo , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/tratamiento farmacológico , Resultado del Tratamiento
3.
Am J Phys Med Rehabil ; 98(5): 360-368, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31003229

RESUMEN

OBJECTIVE: The aim of the study was to identify optimal muscle selection patterns for onabotulinumtoxinA treatment of poststroke lower-limb spasticity. DESIGN: Adults with poststroke lower-limb spasticity (ankle Modified Ashworth Scale ≥3) were randomized to onabotulinumtoxinA (300 U, mandatory ankle plantar flexors; ≤100 U, optional lower-limb muscles) or placebo. Post hoc analysis assessed the impact of muscle selection patterns on ankle Modified Ashworth Scale and physician-assessed Clinical Global Impression of Change based on change from baseline to average of weeks 4/6 versus placebo. RESULTS: Among 468 patients randomized, onabotulinumtoxinA improved ankle Modified Ashworth Scale (-0.81 vs -0.61, P = 0.01) and Clinical Global Impression of Change (0.86 vs 0.65, P = 0.012) versus placebo. Injection of mandatory muscles alone was not sufficient in improving ankle Modified Ashworth Scale (P = 0.255) or Clinical Global Impression of Change (P = 0.576) versus placebo but was adequate 24 mos or less after stroke (Modified Ashworth Scale, -1.13 vs -0.62, P = 0.019; Clinical Global Impression of Change, 1.24 vs 0.68, P = 0.006). Additional injections into toe muscles (flexor digitorum longus, flexor hallucis longus) improved ankle Modified Ashworth Scale (-0.98 vs -0.52, P = 0.002) and Clinical Global Impression of Change (0.80 vs 0.38, P = 0.023) versus placebo regardless of time since stroke. OnabotulinumtoxinA was well tolerated, with no new safety findings. CONCLUSIONS: Post hoc analyses suggested additional injections of onabotulinumtoxinA into toe flexors improved ankle Modified Ashworth Scale and Clinical Global Impression of Change scores versus mandatory muscles alone overall and with treatment initiation more than 24 mos after stroke.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Rehabilitación de Accidente Cerebrovascular/métodos , Accidente Cerebrovascular/complicaciones , Anciano , Método Doble Ciego , Femenino , Humanos , Inyecciones Intramusculares , Pierna/inervación , Masculino , Persona de Mediana Edad , Espasticidad Muscular/etiología , Fármacos Neuromusculares/uso terapéutico , Accidente Cerebrovascular/tratamiento farmacológico , Resultado del Tratamiento
4.
Stroke ; 49(9): 2129-2137, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-30354975

RESUMEN

Background and Purpose- Intrathecal baclofen (ITB) is an effective treatment for managing patients with severe poststroke spasticity, who can experience continued pain and decline in their quality of life (QoL). SISTERS (Spasticity In Stroke-Randomized Study) was a randomized, controlled, open-label, multicenter, phase 4 study to evaluate ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of poststroke spasticity. Methods- Poststroke patients with spasticity in ≥2 extremities and an Ashworth Scale score of ≥3 in ≥2 affected lower extremity muscle groups were randomized (1:1) to ITB (N=31) or CMM (N=29). Both treatment arms received physiotherapy throughout. The primary outcome was the change in average Ashworth Scale score in the lower extremities of the affected side from baseline to month 6. Here, we report results for secondary outcomes: pain via the Numeric Pain Rating Scale, health-related QoL by the EuroQol-5 dimensional 3 level utility score and health status visual analog scale score, stroke-specific QoL, and patient satisfaction. Analyses were performed on an intention-to-treat basis. Results- We observed significant treatment effects in favor of ITB over CMM for changes from baseline to month 6 in Numeric Pain Rating Scale scores for actual pain (ITB versus CMM: mean, -1.17 [SD, 3.17] versus 0.00 [3.29]; median, -1.00 versus 0.00; P=0.0380) and least pain (mean, -1.61 [2.29] versus 0.24 [3.07]; median, -1.00 versus 0.00; P=0.0136), and EuroQol-5 dimensional 3 level utility scores (mean, +0.09 [0.26] versus +0.01 [0.16]; median, +0.07 versus 0.00; P=0.0197). Between-group differences were not statistically significant for EuroQol-5 dimensional 3 level visual analog scale, stroke-specific QoL summary, or Numeric Pain Rating Scale worst pain scores, although ITB patients showed greater numeric improvements from baseline during follow-up. More ITB patients than CMM patients (73% versus 48%) were satisfied with the spasticity reduction at month 6. Conclusions- These data support that ITB therapy is associated with improvements in pain and QoL in poststroke patients. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01032239.


Asunto(s)
Baclofeno/administración & dosificación , Relajantes Musculares Centrales/administración & dosificación , Espasticidad Muscular/tratamiento farmacológico , Dolor/tratamiento farmacológico , Calidad de Vida , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/complicaciones , Administración Oral , Anciano , Benzodiazepinas/uso terapéutico , Clonidina/análogos & derivados , Clonidina/uso terapéutico , Dantroleno/uso terapéutico , Femenino , Humanos , Infusión Espinal , Masculino , Persona de Mediana Edad , Relajantes Musculares Centrales/uso terapéutico , Espasticidad Muscular/etiología , Dolor/etiología , Dimensión del Dolor , Satisfacción del Paciente , Modalidades de Fisioterapia , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
5.
PM R ; 10(7): 693-703, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29330071

RESUMEN

BACKGROUND: Poststroke distal lower limb spasticity impairs mobility, limiting activities of daily living and requiring additional caregiver time. OBJECTIVE: To evaluate the efficacy, safety, and sustained benefit of onabotulinumtoxinA in adults with poststroke lower limb spasticity (PSLLS). DESIGN: A multicenter, randomized, double-blind, phase 3, placebo-controlled trial (NCT01575054). SETTING: Sixty study centers across North America, Europe, Russia, the United Kingdom, and South Korea. PATIENTS: Adult patients (18-65 years of age) with PSLLS (Modified Ashworth Scale [MAS] ≥3) of the ankle plantar flexors and the most recent stroke ≥3 months before study enrollment. INTERVENTIONS: During the open-label phase, patients received ≤3 onabotulinumtoxinA treatments (≤400 U) or placebo at approximately 12-week intervals. Treatments were into the ankle plantar flexors (onabotulinumtoxinA 300 U into ankle plantar flexors; ≤100 U, optional lower limb muscles). MAIN OUTCOME MEASUREMENTS: The double-blind primary endpoint was MAS change from baseline (average score at weeks 4 and 6). Secondary measures included physician-assessed Clinical Global Impression of Change (CGI), MAS change from baseline in optional muscles, Goal Attainment Scale (GAS), and pain scale. RESULTS: Of 468 patients enrolled, 450 (96%) completed the double-blind phase and 413 (88%) completed the study. Small improvements in MAS observed with onabotulinumtoxinA during the double-blind phase (onabotulinumtoxinA, -0.8; placebo, -0.6, P = .01) were further enhanced with additional treatments through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, -1.2; placebo/onabotulinumtoxinA, -1.4). Small improvements in CGI observed during the double-blind phase (onabotulinumtoxinA, 0.9; placebo, 0.7, P = .01) were also further enhanced through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, 1.6; placebo/onabotulinumtoxinA, 1.6). Physician- and patient-assessed GAS scores improved with each subsequent treatment. No new safety signals emerged. CONCLUSIONS: OnabotulinumtoxinA significantly improved ankle MAS, CGI, and GAS scores compared with placebo; improvements were consistent and increased with repeated treatments of onabotulinumtoxinA over 1 year in patients with PSLLS. LEVEL OF EVIDENCE: I.


Asunto(s)
Actividades Cotidianas , Toxinas Botulínicas Tipo A/administración & dosificación , Espasticidad Muscular/tratamiento farmacológico , Músculo Esquelético/fisiopatología , Accidente Cerebrovascular/complicaciones , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Inyecciones Intramusculares , Extremidad Inferior , Masculino , Persona de Mediana Edad , Espasticidad Muscular/etiología , Espasticidad Muscular/fisiopatología , Músculo Esquelético/efectos de los fármacos , Fármacos Neuromusculares/administración & dosificación , Resultado del Tratamiento , Adulto Joven
6.
J Neurol Neurosurg Psychiatry ; 89(6): 642-650, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29326296

RESUMEN

BACKGROUND: Intrathecal baclofen (ITB) is a treatment option for patients with severe poststroke spasticity (PSS) who have not reached their therapy goal with other interventions. METHODS: 'Spasticity In Stroke-Randomised Study' (SISTERS) was a randomised, controlled, open-label, multicentre phase IV study to evaluate the efficacy and safety of ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of PSS. Patients with chronic stroke with spasticity in ≥2 extremities and an Ashworth Scale (AS) score ≥3 in at least two affected muscle groups in the lower extremities (LE) were randomised (1:1) to ITB or CMM. Both treatment arms received physiotherapy throughout. The primary outcome was the change in the average AS score in the LE of the affected body side from baseline to month 6. Analyses were performed for all patients as randomised (primary analysis) and all randomised patients as treated (safety analysis). RESULTS: Of 60 patients randomised to ITB (n=31) or CMM (n=29), 48 patients (24 per arm) completed the study. The primary analysis showed a significant effect of ITB therapy over CMM (mean AS score reduction, -0.99 (ITB) vs -0.43 (CMM); Hodges-Lehmann estimate, -0.667(95.1%CI -1.0000 to -0.1667); P=0.0140). More patients reported adverse events while receiving ITB (24/25 patients, 96%; 149 events) compared with CMM (22/35, 63%; 77 events), although events were generally consistent with the known safety profile of ITB therapy. CONCLUSIONS: These data support the use of ITB therapy as an alternative to CMM for treatment of generalised PSS in adults. TRIAL REGISTRATION NUMBER: NCT01032239; Results.


Asunto(s)
Baclofeno/uso terapéutico , Relajantes Musculares Centrales/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Accidente Cerebrovascular/complicaciones , Adulto , Anciano , Esquema de Medicación , Femenino , Humanos , Inyecciones Espinales , Masculino , Persona de Mediana Edad , Espasticidad Muscular/etiología , Recuperación de la Función , Resultado del Tratamiento , Adulto Joven
7.
Eur J Phys Rehabil Med ; 54(4): 605-617, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29265792

RESUMEN

Spastic paresis is a common feature of an upper motor neuron impairment caused by stroke, brain injury, multiple sclerosis and other central nervous system (CNS) disorders. Existing national and international guidelines for the treatment of adult spastic paresis tend to focus on the treatment of muscle overactivity rather than the comprehensive approach to care, which may require life-long management. Person-centered care is increasingly adopted by healthcare systems in a shift of focus from "disease-oriented" towards "person-centered" medicine. The challenge is to apply this principle to the complex management of spastic paresis and to include an educative process that engages care providers and patients and encourages them to participate actively in the long-term management of their own disease. To address this issue, a group of 13 international clinicians and researchers used a pragmatic top-down methodology to evaluate the evidence and to formulate and grade the strength of recommendations for applying the principles of person-centered care to the management of spastic paresis. There is a distinct lack of clinical trial evidence regarding the application of person-centered medicine to the rehabilitation setting. However, the current evidence base supports the need to ensure that treatment interventions for spastic paresis should be centered on as far as reasonable on the patient's own priorities for treatment. Goal setting, negotiation and formal recording of agreed SMART goals should be an integral part of all spasticity management programs, and goal attainment scaling should be recorded alongside other standardized measures in the evaluation of outcome. When planning interventions for spastic paresis, the team should consider the patient and their family's capacity for self-rehabilitation, as well as ways to enhance this approach. Finally, the proposed intervention and treatment goals should consider the impact of any neuropsychological, cognitive and behavioral deficits on rehabilitation. These recommendations support a person-centric focus in the management of spastic paresis.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Evaluación de la Discapacidad , Terapia por Ejercicio/métodos , Paraparesia Espástica/diagnóstico , Paraparesia Espástica/rehabilitación , Atención Dirigida al Paciente/métodos , Adulto , Terapia Combinada , Consenso , Manejo de la Enfermedad , Femenino , Humanos , Masculino , Paraparesia Espástica/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Pronóstico , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
10.
J Pain Symptom Manage ; 52(1): 17-26, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27037050

RESUMEN

CONTEXT: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life. OBJECTIVES: To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial. METHODS: Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain ≥4 achieving ≥30% and ≥50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52. RESULTS: At baseline, most patients (74.3%) experienced pain and 47.4% had pain ≥4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P < 0.05). Higher proportions of patients in the pain subgroup achieved ≥30% and ≥50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P < 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work. CONCLUSION: This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS.


Asunto(s)
Analgésicos/uso terapéutico , Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/etiología , Dolor/tratamiento farmacológico , Dolor/etiología , Accidente Cerebrovascular/complicaciones , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/fisiopatología , Fármacos Neuromusculares/uso terapéutico , Dolor/fisiopatología , Dimensión del Dolor , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/fisiopatología , Resultado del Tratamiento , Adulto Joven
11.
Int J Stroke ; 9 Suppl A100: 76-84, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25088427

RESUMEN

BACKGROUND: There is currently no standardized process for long-term follow-up care. As a result, management of poststroke care varies greatly, and the needs of stroke survivors are not fully addressed. The Post Stroke Checklist was developed by the Global Stroke Community Advisory Panel as a means of standardizing long-term stroke care. Since its development, the Post Stroke Checklist has gained international recognition from various stroke networks and is endorsed by the World Stroke Organization to support improved stroke survivor follow-up and care. AIMS: The aim of this study was to evaluate the feasibility and usefulness of the Post Stroke Checklist in clinical practice and assess its relevance to stroke survivors in pilot studies in the United Kingdom and Singapore. METHODS: The Post Stroke Checklist was administered to stroke survivors in the United Kingdom (n = 42) and Singapore (n = 100) by clinicians. To assess the feasibility of the Post Stroke Checklist in clinical practice, an independent researcher observed the assessment and made notes relating to the patient-clinician interaction and their interpretations of the Post Stroke Checklist items. Patient and clinician satisfaction with the Post Stroke Checklist was assessed by three questions, responded to on a 0-10 numerical rating scale. Clinicians also completed a Pragmatic Face and Content Validity test to evaluate their overall impressions of the Post Stroke Checklist. In the United Kingdom, a subset of patients (n = 14) took part in a concept elicitation interview prior to being administered the Post Stroke Checklist, followed by a cognitive debriefing interview to assess relevance and comprehension of the Post Stroke Checklist. RESULTS: The Post Stroke Checklist identified frequently reported problems for stroke survivors including cognition (reported by 47·2% of patients), mood (43·7%), and life after stroke (38%). An average of 3·2 problems per patient was identified across both countries (range 0-10). An average of 5 and 2·6 problems per patient were identified in the United Kingdom and Singapore, respectively. The average time taken to administer the Post Stroke Checklist was 17 mins (standard deviation 7·5) in Singapore and 13 mins (standard deviation 7·6) in the United Kingdom. Satisfaction ratings were high for patients (8·6/10) and clinicians (7·7/10), and clinician feedback via the Pragmatic Face and Content Validity test indicated that the Post Stroke Checklist is 'useful', 'informative', and 'exhaustive'. All concepts measured by the Post Stroke Checklist were spontaneously discussed by patients during the concept elicitation interviews, suggesting that the Post Stroke Checklist is relevant to stroke survivors. Cognitive debriefing data indicated that the items were generally well understood and relevant to stroke. Minor revisions were made to the Post Stroke Checklist based on patient feedback. CONCLUSIONS: The findings suggest that the Post Stroke Checklist is a feasible and useful measure for identifying long term stroke care needs in a clinical practice setting. Pilot testing indicated that the Post Stroke Checklist is able to identify a wide range of unmet needs, and patient and clinician feedback indicated a high level of satisfaction with the Post Stroke Checklist assessment. The items were generally well understood and considered relevant to stroke survivors, indicating the Post Stroke Checklist is a feasible, useful, and relevant measure of poststroke care.


Asunto(s)
Lista de Verificación , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Cuidados a Largo Plazo , Masculino , Persona de Mediana Edad , Proyectos Piloto , Calidad de Vida , Reproducibilidad de los Resultados , Singapur/epidemiología , Accidente Cerebrovascular/psicología , Encuestas y Cuestionarios , Sobrevivientes/psicología , Sobrevivientes/estadística & datos numéricos , Reino Unido/epidemiología , Adulto Joven
12.
J Rehabil Med ; 46(6): 504-13, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24715249

RESUMEN

OBJECTIVE: Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity. METHODS: Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks. The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks (or 10 weeks after an optional second injection). Secondary endpoints included achievement of a different active or a passive goal at this timepoint. RESULTS: The intent-to-treat population comprised 273 patients. The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care. Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care (60.0%) vs. placebo + standard of care (38.6%) (odds ratio, 2.46; 95% confidence interval, 1.18-5.14) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups. CONCLUSIONS: Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function.


Asunto(s)
Logro , Toxinas Botulínicas Tipo A/uso terapéutico , Objetivos , Fármacos Neuromusculares/uso terapéutico , Rehabilitación de Accidente Cerebrovascular , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Placebos , Estudios Prospectivos , Accidente Cerebrovascular/complicaciones , Adulto Joven
14.
Toxicon ; 67: 129-40, 2013 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-23415704

RESUMEN

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of certain urologic conditions, including detrusor sphincter dyssynergia (DSD), lower urinary tract symptoms due to benign prostatic hyperplasia (BPH), and detrusor overactivity (both neurogenic [NDO] and idiopathic [IDO]), an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, for the serotypes BoNT-A and BoNT-B, as well as for the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations on the use of BoNT for the management of these urologic conditions based upon the strength of clinical evidence and following the AAN classification scale. For the treatment of DSD, the evidence supported a Level B recommendation for the use of A/Ona; A/Abo, A/Inco, and B/Rima received a Level U recommendation. For the treatment of NDO, there was sufficient clinical evidence to support a Level A recommendation for BoNT-A as well as for both A/Ona and A/Abo; no published data were identified for either A/Inco or B/Rima (Level U). For the treatment of IDO, the evidence supported a Level A recommendation for A/Ona; A/Inco, A/Abo, and B/Rima received a Level U recommendation. For the management of BPH, the evidence supported a Level B recommendation for BoNT and A/Ona; no published studies were identified for A/Abo, A/Inco, or B/Rima, warranting a Level U recommendation for these three formulations. Further studies are needed to evaluate the efficacy and safety of BoNT for the management of urologic conditions.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Medicina Basada en la Evidencia , Neurotoxinas/uso terapéutico , Enfermedades de la Vejiga Urinaria/tratamiento farmacológico , Adulto , Niño , Humanos , Masculino , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Traumatismos de la Médula Espinal/complicaciones , Resultado del Tratamiento , Vejiga Urinaria Neurogénica/tratamiento farmacológico , Vejiga Urinaria Neurogénica/etiología , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/etiología
15.
Handb Clin Neurol ; 110: 145-60, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23312638

RESUMEN

This chapter aims to address the questions of the definition and effective management of spasticity, in order to assist the reader to recognize, assess, and treat people with this impairment. Spasticity is a physiological consequence of an insult to the brain or spinal cord, which can lead to life-threatening, disabling, and costly consequences. It is a common but not inevitable outcome of the upper motor neuron (UMN) syndrome and is characterized by muscle overactivity and high tone spasms, which, if left untreated, will lead to muscle and soft tissue contracture and limb deformity. There have been several attempts to define spasticity. The difficulty reflects the complex features of the syndrome. The most cited definition is by Lance, but does not fulfil all the clinical scenarios seen in clinical practice. The term "spasticity" in the therapeutic world covers the several other features of the UMN syndrome and, therefore, an all embracing definition is probably required as well. Rates for the prevalence of spasticity in different clinical conditions are variable. This may be due to the presence of many patients with mild spasticity, for whom little or no treatment is required for their condition. However, it is estimated that 38% of patients following stroke develop a degree of spasticity and about 19% require pharmacological treatment. Of these about one-third (5% of the total) will benefit from botulinum toxin injections for focal problems. This chapter will inform the reader about the pathophysiology of spasticity, but also includes the practicalities and principles of management, the delivery of its longer term treatments, and the utilization and measurement of relevant outcomes.


Asunto(s)
Enfermedades del Sistema Nervioso Central/complicaciones , Espasticidad Muscular/terapia , Humanos , Espasticidad Muscular/diagnóstico , Espasticidad Muscular/etiología
16.
J Rehabil Med ; 45(1): 1-5, 2013 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23223938

RESUMEN

BACKGROUND: One of the objectives of the International Society for Physical and Rehabilitation Medicine is to improve the continuity of World Congresses. This requires the development of an abstract topic list for use in congress announcements and abstract submissions. METHODS: An abstract topic list was developed on the basis of the definitions of human functioning and rehabilitation research, which define 5 main areas of research (biosciences in rehabilitation, biomedical rehabilitation sciences and engineering, clinical Physical and Rehabilitation Medicine (PRM) sciences, integrative rehabilitation sciences, and human functioning sciences). For the abstract topic list, these research areas were grouped according to the proposals of congress streams. In a second step, the first version of the list was systematically compared with the topics of the 2003 ISPRM World Congress. RESULTS: The resulting comprehensive abstract topic list contains 5 chapters according to the definition of human functioning and rehabilitation research. Due to the high significance of clinical research, clinical PRM sciences were placed at the top of the list, comprising all relevant health conditions treated in PRM services. For congress announcements a short topic list was derived. DISCUSSION: The ISPRM topic list is sustainable and covers a full range of topics. It may be useful for congresses and elsewhere in structuring research in PRM.


Asunto(s)
Investigación Biomédica/normas , Congresos como Asunto/organización & administración , Medicina Física y Rehabilitación/organización & administración , Congresos como Asunto/normas , Humanos , Sociedades Médicas
17.
J Stroke Cerebrovasc Dis ; 22(7): e173-80, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23265778

RESUMEN

BACKGROUND: Long-term care for stroke survivors is fragmented and lacks an evidence-based, easy-to-use tool to identify persistent long-term problems among stroke survivors and streamline referral for treatment. We sought to develop a poststroke checklist (PSC) to help health care professionals identify poststroke problems amenable to treatment and subsequent referral. METHODS: An instrument development team, supported by measurement experts, international stroke experts, and poststroke care stakeholders, was created to develop a long-term PSC. A list of long-term poststroke problem areas was generated by an international, multidisciplinary group of stroke experts, the Global Stroke Community Advisory Panel. Using Delphi methods, a consensus was reached on which problem areas on the list were most important and relevant to include in a PSC. The instrument development team concurrently created the actual checklist, which provided example language about how to ask about poststroke problem areas and linked patient responses to a specific referral process. RESULTS: Eleven long-term poststroke problem areas were rated highly and consistently among stroke experts participating in the Delphi process (n = 12): secondary prevention, activities of daily living, mobility, spasticity, pain, incontinence, communication, mood, cognition, life after stroke, and relationship with caregiver. These problem areas were included in the long-term PSC. CONCLUSIONS: The PSC was developed to be a brief and easy-to-use tool, intended to facilitate a standardized approach for health care providers to identify long-term problems in stroke survivors and to facilitate appropriate referrals for treatment.


Asunto(s)
Cuidadores , Lista de Verificación , Accidente Cerebrovascular/terapia , Continuidad de la Atención al Paciente , Técnica Delphi , Estudios de Seguimiento , Humanos , Cuidados a Largo Plazo , Calidad de Vida , Rehabilitación de Accidente Cerebrovascular , Sobrevivientes
18.
Toxicon ; 67: 115-28, 2013 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-23220492

RESUMEN

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of spasticity associated with the upper motor neuron syndrome (UMNS), an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, the serotypes BoNT-A and BoNT-B, as well as the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations on the effectiveness of BoNT for the management of spasticity, based upon the strength of clinical evidence and following the AAN classification scale. While the prior report by the AAN provided recommendations for the use of BoNT as a class of drug, this report provides more detail and includes recommendations for the individual formulations. For the treatment of upper limb spasticity, the evidence supported a Level A recommendation for BoNT-A, A/Abo, and A/Ona, with a Level B recommendation for A/Inco; there was insufficient evidence to support a recommendation for B/Rima. For lower limb spasticity, there was sufficient clinical evidence to support a Level A recommendation for A/Ona individually and BoNT-A in aggregate; the clinical evidence for A/Abo supported a Level C recommendation; and there was insufficient information to recommend A/Inco and B/Rima (Level U). There is a need for further comparative effectiveness studies of the available BoNT formulations for the management of spasticity.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Medicina Basada en la Evidencia , Enfermedad de la Neurona Motora/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Neurotoxinas/uso terapéutico , Humanos , Inyecciones Intramusculares , Enfermedad de la Neurona Motora/complicaciones , Espasticidad Muscular/etiología , Unión Neuromuscular/efectos de los fármacos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
19.
Eur J Neurol ; 19(1): 21-7, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21707868

RESUMEN

BACKGROUND: Spasticity occurs after stroke and gives rise to substantial burden for patients and caregivers. Although it has been studied for many years, its definition continues to undergo reconsideration and revision. This partly reflects the diversity of its manifestations and that its pathophysiology, although well studied, is still debated. METHODS: A literature review was carried out to define the pathophysiology and risk factors for onset of post-stroke spasticity. RESULTS: It is clear that an acquired brain injury, including stroke, results in an imbalance of inhibitory and excitatory impulses that leads to upper motor neuron symptoms and that the location and extent of the lesions result in differing symptoms and degrees of spastic severity. The onset of spasticity is highly variable and may occur shortly or more than 1 year after stroke. The current understanding of spasticity onset is complicated by the role of contractures, which have been assumed to arise out of spasticity but may have a role in its cause. Other possibly predictive factors for the risk of post-stroke spasticity have been identified, including early arm and leg weakness, left-sided weakness, early reduction in activities of daily living, and a history of smoking. CONCLUSIONS: Further understanding of spasticity risk factors is necessary for the development and integration of early interventions and preventive measures to reduce spasticity onset and severity.


Asunto(s)
Espasticidad Muscular/etiología , Espasticidad Muscular/fisiopatología , Accidente Cerebrovascular/complicaciones , Humanos , Factores de Riesgo
20.
J Rehabil Med ; 43(1): 8-14, 2011 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21174050

RESUMEN

OBJECTIVE: Goal attainment scaling represents a unique approach to identifying and quantifying individualized, meaningful treatment outcomes, and its use in the rehabilitation medicine setting is increasing. The aim of this paper is to discuss the available literature for goal attainment scaling in patients with acquired brain injury, in terms of its advantages, disadvantages and practical application, including examples of goal setting and scaling.


Asunto(s)
Lesiones Encefálicas/rehabilitación , Objetivos , Evaluación de Resultado en la Atención de Salud/métodos , Actividades Cotidianas , Lesiones Encefálicas/etiología , Lesiones Encefálicas/fisiopatología , Humanos , Evaluación de Programas y Proyectos de Salud , Accidente Cerebrovascular/complicaciones , Rehabilitación de Accidente Cerebrovascular
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