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1.
Neuromodulation ; 24(8): 1412-1421, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32347591

RESUMO

OBJECTIVES: Translingual neurostimulation (TLNS) studies indicate improved outcomes in neurodegenerative disease or spinal cord injury patients. This study was designed to assess the safety and efficacy of TLNS plus targeted physical therapy (PT) in people with a chronic balance deficit after mild-to-moderate traumatic brain injury (mmTBI). MATERIALS AND METHODS: This international, multicenter, randomized study enrolled 122 participants with a chronic balance deficit who had undergone PT following an mmTBI and had plateaued in recovery. Randomized participants received PT plus either high-frequency pulse (HFP; n = 59) or low-frequency pulse (LFP; n = 63) TLNS. The primary efficacy and safety endpoints were the proportion of sensory organization test (SOT) responders (SOT composite score improvement of ≥15 points) and fall frequency after five weeks of treatment, respectively. RESULTS: The proportion of SOT responders was significant in the HFP + PT (71.2%) and LFP + PT (63.5%) groups compared with baseline (p < 0.0005). For the pooled population, the SOT responder rate was 67.2% (p < 0.00005), and there were clinically and statistically significant improvements in SOT composite scores after two and five weeks (p < 0.0005). Both groups had reductions in falls and headache disability index scores. Mean dynamic gait index scores in both groups also significantly increased from baseline at weeks 2 and 5. CONCLUSIONS: Significant improvements in balance and gait, in addition to headaches, sleep quality, and fall frequency, were observed with TLNS plus targeted PT; in participants who had a chronic balance deficit following an mmTBI and had plateaued on prior conventional physiotherapy.


Assuntos
Lesões Encefálicas Traumáticas , Doenças Neurodegenerativas , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/terapia , Humanos , Modalidades de Fisioterapia , Equilíbrio Postural , Estudos Prospectivos , Qualidade do Sono
2.
Curr Med Res Opin ; 36(12): 1999-2007, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33095678

RESUMO

BACKGROUND: This study aimed to establish the minimal clinically important difference (MCID) for the Fugl-Meyer Motor Scale (FMMS) and the Disability Rating Scale (DRS) to evaluate interventions in patients with motor deficits in the chronic phase after traumatic brain injury (TBI). METHODS: MCIDs were established with a structured expert consultation process, the RAND/UCLA modified Delphi method. This process consisted of a literature review and input from a 10-person, multidisciplinary expert panel. The experts were asked to rate meaningfulness of improvements in hypothetical patients and numeric changes via two rounds of ratings and an in-person meeting. RESULTS: The estimated MCIDs were six and five points on the FMMS Upper and Lower Extremity Scale, respectively, and one point on the DRS. The experts argued against establishing an MCID for the combined FMMS because the same change was more likely to be meaningful if concentrated in one extremity and because a meaningful improvement in one extremity implies meaningfulness irrespective of the changes in the other. CONCLUSIONS: This study is the first to establish MCIDs for the FMMS and the DRS in the chronic phase after TBI. The results may be helpful for the design and interpretation of clinical trials of interventions.


Assuntos
Lesões Encefálicas Traumáticas/terapia , Diferença Mínima Clinicamente Importante , Lesões Encefálicas Traumáticas/etiologia , Avaliação da Deficiência , Prova Pericial , Humanos , Extremidade Inferior/fisiopatologia , Destreza Motora , Extremidade Superior/fisiopatologia
3.
J Patient Exp ; 5(4): 244-249, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30574543

RESUMO

Hallmarks of the difficult period of transition from hospital to home following stroke include stroke survivor and caregiver uncertainty about actionable steps toward recovery and prevention and unfamiliarity with related resources. Current research shows that interdisciplinary interventions focusing on patient experience and patient education enable health-care providers to activate and empower patients, potentially leading to better clinical outcomes. Tool kit approaches have been successfully used to aid patients through ongoing education after hospital discharge and to improve patient experience. In this article, we describe our efforts to iteratively develop and test personalized stroke management tool kits aimed at connecting stroke survivors and their caregivers to empowering resources, while soliciting feedback from patients and family members.

4.
Stroke ; 49(9): 2129-2137, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30354975

RESUMO

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.


Assuntos
Baclofeno/administração & dosagem , Relaxantes Musculares Centrais/administração & dosagem , Espasticidade Muscular/tratamento farmacológico , Dor/tratamento farmacológico , Qualidade de Vida , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral/complicações , Administração Oral , Idoso , Benzodiazepinas/uso terapêutico , Clonidina/análogos & derivados , Clonidina/uso terapêutico , Dantroleno/uso terapêutico , Feminino , Humanos , Infusão Espinal , Masculino , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/etiologia , Dor/etiologia , Medição da Dor , Satisfação do Paciente , Modalidades de Fisioterapia , Índice de Gravidade de Doença , Resultado do Tratamento
5.
Arch Phys Med Rehabil ; 99(8): 1681-1687, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29428347

RESUMO

The recognition, evaluation, and management of disabling spasticity in persons with spinal cord damage (SCD) is a challenge for health care professionals, institutions, health systems, and patients. To guide the assessment and management of disabling spasticity in individuals with SCD, the Ability Network, an international panel of clinical experts, developed a clinical care pathway. The aim of this pathway is to facilitate treatment decisions that take into account the effect of disabling spasticity on health status, individual preferences and treatment goals, tolerance for adverse events, and burden on caregivers. The pathway emphasizes a patient-centered, individualized approach and the need for interdisciplinary coordination of care, patient involvement in goal setting, and the use of assessment and outcome measures that lend themselves to practical application in the clinic. The clinical care pathway is intended for use by health care professionals who provide care for persons with SCD and disabling spasticity in various settings. Barriers to optimal spasticity management in these people are also discussed. There is an urgent need for the clinical community to clarify and overcome barriers (knowledge-based, organizational, health system) to optimizing the management of spasticity in people with SCD.


Assuntos
Tomada de Decisão Clínica/métodos , Procedimentos Clínicos , Avaliação da Deficiência , Espasticidade Muscular/diagnóstico , Traumatismos da Medula Espinal/complicações , Humanos , Espasticidade Muscular/etiologia
6.
J Neurol Neurosurg Psychiatry ; 89(6): 642-650, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29326296

RESUMO

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.


Assuntos
Baclofeno/uso terapêutico , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Acidente Vascular Cerebral/complicações , Adulto , Idoso , Esquema de Medicação , Feminino , Humanos , Injeções Espinhais , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/etiologia , Recuperação de Função Fisiológica , Resultado do Tratamento , Adulto Jovem
7.
Infect Control Hosp Epidemiol ; 38(8): 921-929, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28615088

RESUMO

OBJECTIVE Carbapenem-resistant Enterobacteriaceae (CRE) are a significant clinical and public health concern. Understanding the distribution of CRE colonization and developing a coordinated approach are key components of control efforts. The prevalence of CRE in the District of Columbia is unknown. We sought to determine the CRE colonization prevalence within healthcare facilities (HCFs) in the District of Columbia using a collaborative, regional approach. DESIGN Point-prevalence study. SETTING This study included 16 HCFs in the District of Columbia: all 8 acute-care hospitals (ACHs), 5 of 19 skilled nursing facilities, 2 (both) long-term acute-care facilities, and 1 (the sole) inpatient rehabilitation facility. PATIENTS Inpatients on all units excluding psychiatry and obstetrics-gynecology. METHODS CRE identification was performed on perianal swab samples using real-time polymerase chain reaction, culture, and antimicrobial susceptibility testing (AST). Prevalence was calculated by facility and unit type as the number of patients with a positive result divided by the total number tested. Prevalence ratios were compared using the Poisson distribution. RESULTS Of 1,022 completed tests, 53 samples tested positive for CRE, yielding a prevalence of 5.2% (95% CI, 3.9%-6.8%). Of 726 tests from ACHs, 36 (5.0%; 95% CI, 3.5%-6.9%) were positive. Of 244 tests from long-term-care facilities, 17 (7.0%; 95% CI, 4.1%-11.2%) were positive. The relative prevalence ratios by facility type were 0.9 (95% CI, 0.5-1.5) and 1.5 (95% CI, 0.9-2.6), respectively. No CRE were identified from the inpatient rehabilitation facility. CONCLUSION A baseline CRE prevalence was established, revealing endemicity across healthcare settings in the District of Columbia. Our study establishes a framework for interfacility collaboration to reduce CRE transmission and infection. Infect Control Hosp Epidemiol 2017;38:921-929.


Assuntos
Carbapenêmicos/uso terapêutico , Infecção Hospitalar/epidemiologia , Infecções por Enterobacteriaceae/epidemiologia , Enterobacteriaceae/efeitos dos fármacos , Resistência beta-Lactâmica , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecção Hospitalar/tratamento farmacológico , District of Columbia/epidemiologia , Infecções por Enterobacteriaceae/tratamento farmacológico , Feminino , Hospitais/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Casas de Saúde/estatística & dados numéricos , Prevalência , Reação em Cadeia da Polimerase em Tempo Real , Instituições de Cuidados Especializados de Enfermagem/estatística & dados numéricos , Adulto Jovem
8.
Neurotherapeutics ; 13(2): 403-17, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27002812

RESUMO

Disturbed sleep is one of the most common complaints following traumatic brain injury (TBI) and worsens morbidity and long-term sequelae. Further, sleep and TBI share neurophysiologic underpinnings with direct relevance to recovery from TBI. As such, disturbed sleep and clinical sleep disorders represent modifiable treatment targets to improve outcomes in TBI. This paper presents key findings from a national working group on sleep and TBI, with a specific focus on the testing and development of sleep-related therapeutic interventions for mild TBI (mTBI). First, mTBI and sleep physiology are briefly reviewed. Next, essential empirical and clinical questions and knowledge gaps are addressed. Finally, actionable recommendations are offered to guide active and efficient collaboration between academic, industry, and governmental stakeholders.


Assuntos
Concussão Encefálica/complicações , Transtornos do Sono-Vigília/etiologia , Actigrafia , Animais , Concussão Encefálica/fisiopatologia , Concussão Encefálica/terapia , Ensaios Clínicos como Assunto , Humanos , Polissonografia , Sono/fisiologia , Transtornos do Sono-Vigília/diagnóstico , Transtornos do Sono-Vigília/fisiopatologia , Transtornos do Sono-Vigília/terapia
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