RESUMO
BACKGROUND: Fatigue is a disabling symptom of multiple sclerosis (MS). The lack of effective therapeutics has promoted the development of cognitive behavioural therapy (CBT)-based fatigue management programmes. However, their efficacy does not sustain over time. We proposed to test the long-term effectiveness of a 6-week fatigue programme supplemented with four booster sessions ('FACETS+') in patients with relapsing remitting MS (RRMS) and fatigue. METHODS: This multicentre, randomised, controlled, open-label, parallel-group trial versus standard care enrolled patients with RRMS and fatigue. Participants were randomised to either FACETS+ plus standard care or standard care alone. The primary outcome measure was fatigue impact (Modified Fatigue Impact Scale (MFIS) at 12 months) based on intention-to-treat analyses. RESULTS: From May 2017 to September 2020, 162 patients were screened; 105 were randomly assigned to FACETS+ (n=57) or standard care (n=48) and 88 completed the primary outcome assessment for the MFIS. At month 12, participants showed improved MFIS compared with baseline in the intervention group (mean difference (MD)=14.0 points; (95% CI 6.45 to 21.5)) and the control group (MD=6.1 points; (95% CI -0.30 to 12.5)) with a significant between-group difference in favour of the intervention group (adjusted MD=7.89 points; (95% CI 1.26 to 14.52), standardised effect size=0.52, p=0.021). No trial-related serious adverse events were reported. CONCLUSIONS: A 6-week CBT-based programme with four booster sessions is superior to standard care alone to treat MS-related fatigue in the long term (12 months follow-up). The results support the use of the FACETS+ programme for the treatment of MS-related fatigue. TRIAL REGISTRATION NUMBER: NCT03758820.
Assuntos
Terapia Cognitivo-Comportamental , Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Humanos , Esclerose Múltipla Recidivante-Remitente/complicações , Esclerose Múltipla Recidivante-Remitente/terapia , Terapia Cognitivo-Comportamental/métodos , Fadiga/etiologia , Fadiga/terapia , Avaliação de Resultados em Cuidados de SaúdeRESUMO
STUDY DESIGN: Prospective observational study. OBJECTIVES: To evaluate melatonin secretion, daytime sleepiness and sleep disorders in patients with spinal cord injuries (SCI), and their association with lesion level. SETTING: Specialized neuro rehabilitation hospital in France METHODS: Prospective observational study of patients aged over 18 hospitalized in for spinal cord injury. Sleep quality was measured with the Pittsburgh Sleep Quality Index (PQSI), daytime sleepiness with the Epworth Sleepiness scale (ESS), and melatonin secretion by 24 h urinary dosage of 6-sulphatoxy-melatonin. RESULTS: 213 patients were screened, 21 patients were included: 17 complete (AIS A) and 4 lesions (AIS B), 76% of traumatic origin with 12 tetraplegic and 9 paraplegic, mean 10 (range 0.5-40) years after injury. Mean age was 46.8 ± 14.7 years, mean BMI 23.56 ± 4.1 and men outnumbered women (15 vs 6). Melatonin secretion was analyzed by 24 h secretion and by secretion profile. Comparing retained vs abolished secretion, only 23% (4/17) of patients with a lesion above T8 retained melatonin secretion, compared to 80% (4/5) with a lesion below T8 (p = 0.022). Non significant differences were found in secretion profile in patients who retained secretion: no patient with a lesion above T8 had a normal secretion profile compared to 50% with a lesion below T8 and in the impact of partial vs total lesions above T8 in whom 17% (2/12) of complete ASIA-A lesions and 50% (2/4) of incomplete lesions retained secretion. CONCLUSION: Lesions of the spinal cord above T8 are strongly associated with abolition of melatonin secretion.
Assuntos
Distúrbios do Sono por Sonolência Excessiva , Melatonina , Transtornos do Sono-Vigília , Traumatismos da Medula Espinal , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sono , Transtornos do Sono-Vigília/etiologia , Traumatismos da Medula Espinal/complicaçõesRESUMO
PURPOSE: To identify specific determinants of non-adherence or cessation of continuous positive airway pressure (CPAP) therapy in a population of patients with spinal cord injuries (SCI). METHODS: Retrospective analysis of data from patients with SCI who underwent a full night supervised polysomnography between 2015 and 2021 and presented with moderate to severe obstructive sleep apnea (OSA) and for whom CPAP was indicated. Adherence was studied at 1, 6, and 12 months. Univariate and multivariate analyses were performed to identify factors associated with non-adherence (< 4 h per night or CPAP cessation). Factors studied were demographic and disease-related data and both subjective and objective sleep parameters. RESULTS: A total of 60 patients were included (40% cervical SCI). In univariate analysis, the only predictive parameters of non-adherence observed at 1, 6, and 12 months were the average use of CPAP on the 1st night (p = 0.02) and over the 1st week (p ≤ 0.001). A complete lesion (AIS-A) was predictive of non-adherence at 1 and 6 months (p = 0.02 at 6 months), while mask leakage was associated with non-adherence at 12 months (p = 0.02). Upper limb autonomy and the presence of family caregivers did not appear to be protective. In multivariate analysis, only the average use in the first week remained predictive of adherence (> 4 h) in the short, medium and long term. CONCLUSION: In patients with SCI and OSA, the 1st week of CPAP treatment seems to be determinant of short-, medium-, and long-term CPAP adherence. Support for SCI patients from the start of treatment is essential and may help avoid treatment failures.
RESUMO
INTRODUCTION: Motor and swallowing dysfunctions in multiple sclerosis (MS) unbalance calorie intake and energy expenditure, modifying nutritional status. Only one study has described nutritional status in MS patients at early disease stages (median Expanded Disability Status Scale [EDSS] = 3), but this has never been assessed in the most severe cases. The goal of the present study was to describe nutritional status in advanced-stage MS. METHODS: The study was a non-interventional retrospective analysis of a prospective registry. We reviewed medical files of consecutive MS patients admitted for annual follow-up in a physical and rehabilitation medicine unit between May 2016 and October 2018. Malnutrition for frail people, according to the French Health Authority (Haute Autorité de Santé [HAS]) definition, was our composite primary outcome criterion: body mass index (BMI) <21 kg/m2 and/or albumin<35 g/L. First, we performed a descriptive analysis of the nutritional status. Second, we studied the association between malnutrition and MS characteristics in univariate and multivariate analyses. RESULTS: A total of 163 patients with median EDSS = 8 [7; 8.5] were included. Ninety-three patients (57%) met HAS malnutrition criteria (36% with albumin <35 g/L, 31% with BMI <21 kg/m2 and 10% with both). Malnutrition was associated in univariate analysis with MS severity (EDSS ≥8.5, p = 0.0003), primary progressive type of MS (p = 0.01) and swallowing disorders (p = 0.002). Multivariate analysis showed that low disability status (EDSS <7) was the only independent (protective) factor associated with malnutrition (OR = 0.2, p = 0.03). CONCLUSIONS: Malnutrition is frequent in advanced stages of MS and is probably a key point for therapeutics, which has never been demonstrated previously. A standardized evaluation should be developed to improve nutritional therapeutic strategies in this population.
Assuntos
Desnutrição , Esclerose Múltipla , Albuminas , Humanos , Desnutrição/epidemiologia , Desnutrição/etiologia , Esclerose Múltipla/complicações , Estado Nutricional , Estudos RetrospectivosRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Espasticidade Muscular/tratamento farmacológico , Fármacos Neuromusculares/administração & dosagem , Qualidade de Vida , Adolescente , Adulto , Idoso , Relação Dose-Resposta a Droga , Extremidades/fisiopatologia , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
STUDY DESIGN: Randomised controlled trial. OBJECTIVES: To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective. SETTING: Rehabilitation department, Garches, France. METHODS: Participants with neurological levels between C6 and C8 were allocated to one of three different groups. The REHAB group underwent training with an occupational therapist. The SELF group carried out a standardised home self-training with a written training guide. The CONTROL group had no training. Participants were assessed at day 15 (D15) and day 30 (D30). The primary outcome was a copying task with and without WPS (WITH and WITHOUT). RESULTS: Forty-two participants (mean age ± SD of 39.8 ± 12) were included and 38 completed the study. At D30, the mean (95% confidence interval) difference in TIS between the CONTROL and SELF groups was 3.8 [-1.7 to 9.4] characters per minute (cpm) (p = 0.23), between the REHAB and SELF groups was 12.9 [7.4 to 18.4] cpm (p < 0.001), and between the REHAB and CONTROL groups was 9.1 [3.5 to 14.6] cpm (p < 0.001). CONCLUSIONS: The results of this study showed that occupational therapist-supervised training improved TIS but word prediction software did not increase TIS. These results suggest that supervised training should be provided to all individuals who are prescribed with devices and systems to facilitate computer access in order to increase their TIS.
Assuntos
Auxiliares de Comunicação para Pessoas com Deficiência , Microcomputadores , Terapia Ocupacional/métodos , Quadriplegia/reabilitação , Software , Traumatismos da Medula Espinal/reabilitação , Adulto , Medula Cervical/lesões , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Quadriplegia/etiologia , Quadriplegia/fisiopatologia , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/fisiopatologiaRESUMO
BACKGROUND: After stroke, spasticity of the rectus femoris (RF) and triceps surae (TS) muscles frequently alters the gait pattern. Knee flexion and ankle dorsiflexion in swing are often reduced, respectively called Stiff Knee Gait (SKG) and equinus. A preliminary uncontrolled study suggested that botulinum toxin type A (BTX-A) injections could improve muscle length and force generated during gait, improving inter-segmental coordination. The aim of this randomised controlled study is thus to evaluate changes in the length of the RF and TS muscles during gait 1 month after either BTX-A or placebo injection in patients with chronic stroke, SKG and spastic equinus. The secondary aims are to evaluate peak length and peak force generated during gait, as well inter-segmental coordination assessed using the continuous relative phase method initially described by Barela et al. in patients with stroke. METHODS: This is a prospective, three-centre, randomised, placebo-controlled, triple blind study over 3 months with 4 visits. Forty patients will be included. During visits V1, V3 and V4, length and force generated by RF and TS during gait will be assessed using musculoskeletal models (MSM). Muscle force will also be assessed using an isokinetic dynamometer. Inter segmental coordination will be evaluated using 3D gait analysis and functional tests will be performed. During V2, patients will receive either an injection of BTX-A in the RF and TS muscles or a placebo injection of saline solution. DISCUSSION: We expect an increase in peak length and a decrease in peak force generated by the RF and TS muscles in the BTX-A group 1 month post injection. Moreover, we expect these parameters to be more improved in the BTX-A than the Control group. This is the first study to assess these parameters in a randomised, controlled trial using instrumented methods (isokinetic evaluation and 3D gait analysis). The results should help to improve understanding of the mechanism(s) underlying improvements in inter-segmental coordination that have been found in many previous uncontrolled studies. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01821573 , First received: March 27, 2013 Last updated: September 14, 2016 Last verified: September 2016 Other Study ID Numbers: P110136 AOM11223.
Assuntos
Toxinas Botulínicas Tipo A/farmacologia , Transtornos Neurológicos da Marcha/tratamento farmacológico , Locomoção/efeitos dos fármacos , Espasticidade Muscular/tratamento farmacológico , Músculo Esquelético/efeitos dos fármacos , Fármacos Neuromusculares/farmacologia , Avaliação de Resultados em Cuidados de Saúde , Acidente Vascular Cerebral/complicações , Adulto , Fenômenos Biomecânicos , Toxinas Botulínicas Tipo A/administração & dosagem , Método Duplo-Cego , Feminino , Transtornos Neurológicos da Marcha/etiologia , Humanos , Masculino , Espasticidade Muscular/etiologia , Fármacos Neuromusculares/administração & dosagem , Estudos ProspectivosRESUMO
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/etiologiaRESUMO
OBJECTIVE: To compare quadriceps fatigability during maximal concentric contractions in persons with multiple sclerosis (MS) and healthy subjects. DESIGN: Observational study. SETTING: Hospital rehabilitation department. PARTICIPANTS: Persons with MS (n=38) and healthy subjects (n=14) were included (N=52). Torque of the knee flexor and extensor muscles and fatigability of the knee extensor muscles were evaluated using an isokinetic device. Surface electromyographic activity of the rectus femoris, vastus lateralis, biceps femoris, and semitendinosus muscles was recorded. INTERVENTIONS: None. MAIN OUTCOME MEASURE: Muscle fatigability (torque fatigue index). RESULTS: The torque fatigue index was lower in persons with MS than in healthy subjects, but when torque was normalized to maximal isometric peak torque, persons with MS and healthy subjects finished the fatigue protocol at exactly the same level of relative strength (50% of the maximal isometric peak torque). Moreover, the reduction in torque was primarily because of a reduction in neuromuscular efficiency, with no changes of coactivation of antagonist muscles. CONCLUSIONS: Although fatigue is a disabling symptom of MS, persons with MS develop less muscle fatigability than healthy subjects during repeated maximal concentric contractions, but they end up at the same level of relative strength.
Assuntos
Músculos Isquiossurais/fisiopatologia , Esclerose Múltipla/fisiopatologia , Contração Muscular/fisiologia , Fadiga Muscular/fisiologia , Músculo Quadríceps/fisiopatologia , Adulto , Eletromiografia , Feminino , Humanos , Contração Isométrica/fisiologia , Masculino , Pessoa de Meia-Idade , TorqueRESUMO
OBJECTIVES: To determine whether the number of words displayed in the word prediction software (WPS) list affects text input speed (TIS) in people with cervical spinal cord injury (SCI), and whether any influence is dependent on the level of the lesion. DESIGN: A cross-sectional trial. SETTING: A rehabilitation center. PARTICIPANTS: Persons with cervical SCI (N=45). Lesion level was high (C4 and C5, American Spinal Injury Association [ASIA] grade A or B) for 15 participants (high-lesion group) and low (between C6 and C8, ASIA grade A or B) for 30 participants (low-lesion group). INTERVENTION: TIS was evaluated during four 10-minute copying tasks: (1) without WPS (Without); (2) with a display of 3 predicted words (3Words); (3) with a display of 6 predicted words (6Words); and (4) with a display of 8 predicted words (8Words). MAIN OUTCOME MEASURES: During the 4 copying tasks, TIS was measured objectively (characters per minute, number of errors) and subjectively through subject report (fatigue, perception of speed, cognitive load, satisfaction). RESULTS: For participants with low-cervical SCI, TIS without WPS was faster than with WPS, regardless of the number of words displayed (P<.001). For participants with high-cervical SCI, the use of WPS did not influence TIS (P=.99). There was no influence of the number of words displayed in a word prediction list on TIS; however, perception of TIS differed according to lesion level. CONCLUSIONS: For persons with low-cervical SCI, a small number of words should be displayed, or WPS should not be used at all. For persons with high-cervical SCI, a larger number of words displayed increases the comfort of use of WPS.
Assuntos
Auxiliares de Comunicação para Pessoas com Deficiência , Quadriplegia/reabilitação , Traumatismos da Medula Espinal/complicações , Interface Usuário-Computador , Adulto , Vértebras Cervicais/lesões , Estudos Transversais , Feminino , Humanos , Masculino , Estudos Prospectivos , SoftwareRESUMO
Optimizing the treatment of disabling spasticity in persons with spinal cord damage is hampered by a lack of consensus regarding the use of acceptable definitions of spasticity and disabling spasticity, and the relative absence of decision tools such as clinical guidelines and concise algorithms to support decision-making within the broader clinical community. Many people with spinal cord damage are managed outside specialist centers, and variations in practice result in unequal access to best practice despite equal need. In order to address these issues, the Ability Network-an international panel of clinical experts-was initiated to develop management algorithms to guide and standardize the assessment, treatment, and evaluation of outcomes of persons with spinal cord damage and disabling spasticity. To achieve this, consensus was sought on common definitions through facilitated, in-person meetings. To guide patient selection, an in-depth review of the available tools was performed and expert consensus sought to develop an appropriate instrument. Literature reviews are guiding the selection and development of tools to evaluate treatment outcomes (body functions, activity, participation, quality of life) as perceived by people with spinal cord damage and disabling spasticity, and their caregivers and clinicians. Using this approach, the Ability Network aims to facilitate treatment decisions that take into account the following: the impact of disabling spasticity on health status, patient preferences, treatment goals, tolerance for adverse events, and in cases of totally dependent persons, caregiver burden.
Assuntos
Comitês Consultivos/organização & administração , Espasticidade Muscular/etiologia , Espasticidade Muscular/reabilitação , Traumatismos da Medula Espinal/complicações , Cuidadores/psicologia , Procedimentos Clínicos/organização & administração , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Planejamento de Assistência ao Paciente , Preferência do Paciente , Qualidade de VidaRESUMO
During neural development in animals, GABAergic and glycinergic neurons are first excitatory, and then become inhibitory in the mature state. This developmental shift is due mainly to strong expression of the cation-chloride K-Cl cotransporter 2 (KCC2) and down-regulation of Na-K-Cl cotransporter 1 (NKCC1) during maturation. The down-regulation of co-transporter KCC2 after spinal cord transection in animals leads to the depolarising (excitatory) action of GABA and glycine and thus results in a reduction of inhibitory synaptic efficiency. Furosemide, a loop diuretic, has been shown to selectively and reversibly block inhibitory postsynaptic potentials without affecting excitatory postsynaptic potentials in animal spinal neurons. Moreover, this diuretic has been also demonstrated to block the cation-chloride co-transporters. Here, we used furosemide to demonstrate changes in spinal inhibitory networks in healthy human subjects. Non-invasive electrophysiological techniques were used to assess presynaptic inhibition, postsynaptic inhibition and the efficacy of synaptic transmission between muscle afferent terminals and soleus motoneurons in the spinal cord. Orally administered furosemide, at doses commonly used in the clinic (40 mg), significantly reduced spinal inhibitory interneuronal activity for at least 70 min from intake compared to control experiments in the same subjects while no changes were observed in the efficacy of synaptic transmission between muscle afferent terminals and soleus motoneurons. The reduction of inhibition was dose-dependent. Our results provide indirect evidence that reversible changes in the cation-chloride transport system induce modulations of inhibitory neuronal activity at spinal cord level in humans.
Assuntos
Diuréticos/farmacologia , Furosemida/farmacologia , Potenciais Pós-Sinápticos Inibidores , Interneurônios/efeitos dos fármacos , Neurônios Motores/efeitos dos fármacos , Medula Espinal/fisiologia , Adulto , Potenciais Pós-Sinápticos Excitadores , Feminino , Humanos , Interneurônios/fisiologia , Masculino , Pessoa de Meia-Idade , Neurônios Motores/fisiologia , Medula Espinal/citologia , Medula Espinal/efeitos dos fármacosRESUMO
Kinematic and kinetic gait parameters have never been assessed following robotic-assisted gait training in hemiparetic patients. Previous studies suggest that restraint of the non-paretic lower limb during gait training could be a useful rehabilitation approach for hemiparetic patients. The aim of this study is to compare a new Lokomat(®) asymmetrical restraint paradigm (with a negative kinematic constraint on the non-paretic limb and a positive kinematic constraint on the paretic limb) with a conventional symmetrical Lokomat(®) training in hemiparetic subjects. We hypothesized that hip and knee kinematics on paretic side would be more improved after the asymmetrical Lokomat(®) training than after the conventional training. In a prospective observational controlled study, 26 hemiparetic subjects were randomized to one of the two groups Lokomat(®) experimental gait training (LE) or Lokomat(®) conventional gait training (LC). They were assessed using 3D gait analysis before, immediately after the 20 min of gait training and following a 20-min rest period. There was a greater increase in peak knee flexion on the paretic side following LE than LC (p = 0.04), and each type of training induced different changes in vertical GRF during single-support phase on the paretic side. Several other spatiotemporal, kinematic and kinetic gait parameters were similarly improved after both types of training. Lokomat(®) restrained gait training with a negative kinematic constraint on the non-paretic limb and a positive kinematic constraint on the paretic limb appears to be an effective approach to specifically improve knee flexion in the paretic lower limb in hemiparetic patients. This study also highlights spatiotemporal, kinematic and kinetic improvements after Lokomat(®) training, in hemiparetic subjects, rarely investigated before.
Assuntos
Terapia por Exercício , Transtornos Neurológicos da Marcha/reabilitação , Marcha , Robótica , Reabilitação do Acidente Vascular Cerebral , Adulto , Idoso , Fenômenos Biomecânicos/fisiologia , Feminino , Articulação do Quadril/fisiopatologia , Humanos , Articulação do Joelho/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , CaminhadaRESUMO
OBJECTIVE: To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen (ITB) therapy in adults, and associated risk factors. DESIGN: A prospective, observational cohort study of adults followed up from January 1 to December 31, 2010. SETTING: A neurologic rehabilitation department in a university hospital. PARTICIPANTS: All consecutive adult subjects (N=158) receiving ITB via a pump, either implanted or followed up during the study period. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Frequency and type of AEs. RESULTS: In 2010, 158 subjects were followed up for ITB therapy, of whom 128 were implanted before 2010 (nonsurgical subjects), and 30 underwent implantation in 2010 (surgical subjects). Of these 30 subjects, 20 were "newly implanted" and 10 were "replacements." The most frequent pathologic disorders were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate of AEs was .023 per month of ITB treatment. AEs were related to the surgical procedure in 53% of cases, to the device in 29% (predominantly catheter dysfunctions), and to adverse effects of baclofen in 18%. AEs related to the surgical incision (scar complications and collections) were more frequent in replacement than newly implanted subjects (P=.009). No significant association between occurrence of an AE and subject characteristics (age, gait capacity, spinal vs cerebral spasticity, duration of ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending admission time by a mean of 16 days. No AE induced long-term morbidity or death. CONCLUSIONS: The AE rate was relatively low in this cohort. This has to be balanced against the clinical, functional, and quality-of-life improvements, which are expected from ITB therapy.
Assuntos
Baclofeno/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Relaxantes Musculares Centrais/efeitos adversos , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Baclofeno/uso terapêutico , Paralisia Cerebral/complicações , Paralisia Cerebral/diagnóstico , Paralisia Cerebral/tratamento farmacológico , Relação Dose-Resposta a Droga , Esquema de Medicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Seguimentos , Humanos , Incidência , Bombas de Infusão Implantáveis , Injeções Espinhais/efeitos adversos , Assistência de Longa Duração , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/complicações , Esclerose Múltipla/diagnóstico , Esclerose Múltipla/tratamento farmacológico , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/fisiopatologia , Estudos Prospectivos , Índice de Gravidade de Doença , Distribuição por Sexo , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/tratamento farmacológico , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Timed Up and Go (TUG) performance is reduced following stroke. Gait training improves gait-related activities in hemiparetic patients. However, no study has compared the impact of a single overground training session with a treadmill training session on gait-related activities (assessed by TUG). OBJECTIVE: To compare the immediate effect of a single overground training session versus a single treadmill training session on TUG performance in hemiparetic patients. METHODS: In this randomized controlled clinical trial, 56 hemiparetic patients were randomized to 1 or 2 distinct groups: a single gait training session overground (O group) or on a treadmill (T group). Time taken to perform the TUG (in seconds) was assessed before and immediately after the completion of each session. RESULTS: Time taken to perform the TUG decreased significantly, and to a similar extent, in both groups following the training session (O group, 5.9%; T group, 5.2%). CONCLUSIONS: An overground training session and a treadmill training session were equally effective in improving TUG performance in hemiparetic patients. Hemiparetic patients should be encouraged to walk regularly overground including turns for 20 minutes without stopping. This is an easy and inexpensive self-rehabilitation method to improve functional gait-related activities involved in the TUG test.
Assuntos
Terapia por Exercício/instrumentação , Terapia por Exercício/métodos , Paresia/reabilitação , Modalidades de Fisioterapia/instrumentação , Reabilitação do Acidente Vascular Cerebral , Adulto , Idoso , Doença Crônica , Feminino , Marcha/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Paresia/fisiopatologia , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento , Caminhada/fisiologiaRESUMO
INTRODUCTION: French Public Health Insurance gathers health, demographic and economic data based on codes from the 10th version of the international classification of diseases (ICD-10), specific nomenclature for each health-care (medical or surgical) procedures, medical expenses and justifications for full coverage of medical care. We aimed to build an algorithm that could identify the French population of people living with spinal cord injury (SCI) relying on public health insurance metadata. MATERIAL AND METHODS: The SNDS (in French, Système National des Données de Santé) was searched for the time-period 2012-2019, looking for: full-coverage motives, ICD-10 codes, and health-therapeutic procedures specific of our population of interest. We built a step-by-step algorithm that identified i)including codes, ii)excluding codes, iii)codes needing confirmation. A group of 3 physicians recognized as experts in this field contributed with data scientists to the selection of pertinent codes and their association. Including codes were ALD-20 (full-coverage 'paraplegia', in French, Affection de Longue Durée), G114 (spastic paraplegia), Q05.x (spina bifida), spinal cord trauma (S14.x; S24.x), vascular myelopathy (G951), degenerative myelopathies (M47.x). Autoimmune, other disabling neurological diseases with a specific ICD code, and oncologic patients were excluded. Neurological symptoms (G82.x) needed confirmation. We identified 6 categories of SCI regarding their etiology, based on ICD-10 code combinations (congenital, genetic, tumoral, traumatic, acquired and symptomatic) Finally antibiotics consumption and hospitalizations of persons identified as SCI were compared to a control sample from overall population (with a 1:5 ratio). RESULTS: Among almost 245 000 persons with putative SCI, we identified 133 849 living individuals with SCI aged>16 (55.8% men, age 57 yo [44;70]) by 2019. Confirmed traumatic SCI were 21 459 (67% were men, age 53 yo [39;67]), acquired non-traumatic were the most frequent (n=62 561, 46.7%). SCI consumed 1.5 to 3-times more antibiotics and were 4-fold more hospitalized than controls. Also, when hospitalized, they remained twice longer in rehabilitation facilities and 3-times longer in acute care. CONCLUSION: Using multiple code entries, our algorithm allowed an exhaustive identification of the French adult SCI population, with an updated epidemiology. This innovative method opens the field for large-scale studies regarding medical history of persons living with SCI by the prism of medical expenses and habits.
RESUMO
As multiple indications for botulinum toxin injections (BTIs) can coexist for neurological patients, there are to date no description of concomitant injections (CIs) to treat both spasticity and neurogenic detrusor overactivity incontinence (NDOI) in patients with spinal cord injuries (SCIs) and multiple sclerosis (MS). We therefore identified patients followed at our institution by health data hub digging, using a specific procedure coding system in use in France, who have been treated at least once with detrusor and skeletal muscle BTIs within the same 1-month period, over the past 5 years (2017-2021). We analyzed 72 patients representing 319 CIs. Fifty (69%) were male, and the patients were mostly SCI (76%) and MS (18%) patients and were treated by a mean number of CIs of 4.4 ± 3.6 [1-14]. The mean cumulative dose was 442.1 ± 98.8 U, and 95% of CIs were performed within a 72 h timeframe. Among all CIs, five patients had symptoms evocative of distant spread but only one had a confirmed pathological jitter in single-fiber EMG. Eleven discontinued CIs for surgical alternatives: enterocystoplasty (five), tenotomy (three), intrathecal baclofen (two) and neurotomy (one). Concomitant BTIs for treating both spasticity and NDOI at the same time appeared safe when performed within a short delay and in compliance with actual knowledge for maximum doses.
Assuntos
Espasticidade Muscular , Traumatismos da Medula Espinal , Bexiga Urinária Hiperativa , Humanos , Espasticidade Muscular/tratamento farmacológico , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Bexiga Urinária Hiperativa/tratamento farmacológico , Adulto , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/tratamento farmacológico , Esclerose Múltipla/complicações , Esclerose Múltipla/tratamento farmacológico , Fármacos Neuromusculares/administração & dosagem , Fármacos Neuromusculares/uso terapêutico , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Toxinas Botulínicas Tipo A/uso terapêutico , Bexiga Urinaria Neurogênica/tratamento farmacológico , Idoso , Injeções Intramusculares , Resultado do TratamentoRESUMO
BACKGROUND: Sleep-disordered breathing (SDB) is frequent in patients with spinal-cord injury (SCI). However, SDB is frequently underdiagnosed due to limited access to diagnostic testing and knowledge about the condition. Moreover, SDB heterogeneity (sleep apnea, obstructive sleep apnea or central sleep apnea and nocturnal alveolar hypoventilation) implies complex evaluation of both nocturnal respiratory effort and hypercapnia. The aim of this study was to compare different screening strategies for an SDB diagnosis in patients with SCI. METHODS: This was a retrospective analysis of data from subjects with SCI followed up in a tertiary-care rehabilitation center with a specialized sleep unit. Subjective (questionnaires) and objective data (polysomnography [PSG]), SpO2 extracted from the PSG, morning blood gases, and nocturnal transcutaneous CO2 (PtcCO2 ) were collected and analyzed. A retrospective comparison of different strategies for SDB screening was carried out. Each strategy was compared (alone and in combination) with the standard of care for sleep apnea (PSG) and nocturnal alveolar hypoventilation (PtcCO2 ) diagnosis. The performance of the usual cutoff and visual analysis was studied. RESULTS: Among 190 subjects with SCI who underwent a full night's PSG, data were available for 104 questionnaires and 162 with oximetry. Nocturnal alveolar hypoventilation was screened by PtcCO2 and blood gases in 52 subjects with SCI. Questionnaires (the modified Screening for Obstructive Sleep Apnea in Tetraplegia and the Epworth Sleepiness Scale) had poor performance for identifying sleep apnea and did not identify nocturnal alveolar hypoventilation. SpO2 (oxygen desaturation index score ≥ 13) and visual analysis of SpO2 were good at identifying sleep apnea but insufficient to identify nocturnal alveolar hypoventilation. Diurnal blood gases were poor predictors of nocturnal alveolar hypoventilation. CONCLUSIONS: Questionnaires were of limited use in subjects with SCI, but the oxygen desaturation index derived from oximetry performed well for sleep apnea screening. Both diurnal blood gases and oximetry visual analysis were insufficient for nocturnal alveolar hypoventilation screening. PtcCO2 monitoring should be mandatory and ideally combined with PSG given the heterogeneity of SDB phenotypes and associated sleep comorbidities of patients with SCI.
RESUMO
BACKGROUND: Gait training for patients with hemiparesis is carried out independently overground or on a treadmill. Several studies have shown differences in hemiparetic gait parameters during overground versus treadmill walking. However, few studies have compared the effects of these 2 gait training conditions on gait parameters, and no study has compared the short-term effects of these techniques on all biomechanical gait parameters. OBJECTIVE: To determine whether a gait training session performed overground or on a treadmill induces specific short-term effects on biomechanical gait parameters in patients with hemiparesis. METHODS: Twenty-six subjects with hemiparesis were randomly assigned to a single session of either overground or treadmill gait training. The short-term effects on spatiotemporal, kinematic, and kinetic gait parameters were assessed using gait analysis before and immediately after the training and after a 20-minute rest. RESULTS: Speed, cadence, percentage of single support phase, peak knee extension, peak propulsion, and braking on the paretic side were significantly increased after the gait training session. However, there were no specific changes dependent on the type of gait training performed (overground or on a treadmill). CONCLUSION: A gait training session performed by subjects with hemiparesis overground or on a treadmill did not induce specific short-term effects on biomechanical gait parameters. The increase in gait velocity that followed a gait training session seemed to reflect specific modifications of the paretic lower limb and adaptation of the nonparetic lower limb.
Assuntos
Teste de Esforço , Terapia por Exercício/métodos , Transtornos Neurológicos da Marcha/etiologia , Transtornos Neurológicos da Marcha/reabilitação , Paresia/complicações , Adulto , Idoso , Fenômenos Biomecânicos , Feminino , Humanos , Articulações/inervação , Masculino , Pessoa de Meia-Idade , Aparelhos Ortopédicos , Resultado do Tratamento , Caminhada/fisiologiaRESUMO
Background: Current guidelines recommend intramuscular botulinum toxin type A (BoNT-A) injection as first-line treatment for spasticity, a frequent and impairing feature of various central nervous system (CNS) lesions such as stroke. Patients with spasticity commonly require BoNT-A injections once every 3 to 4 months. We conducted a nationwide, population-based, retrospective cohort study, using the French National Hospital Discharge Database (PMSI), to describe BoNT-A use for spasticity in clinical practice in France between 2014 and 2020. The PMSI database covers the whole French population, corresponding to over 66 million persons. Methods: We first searched the PMSI database for healthcare facility discharge of patients who received BoNT-A injections between 2014 and 2020, corresponding to the first set. For each BoNT-A-treated patient, we identified the medical condition for which BoNT-A may have been indicated. Another search of the PMSI database focused on patients admitted for acute stroke between 2014 and 2016 and their spasticity-related care pathway (second set). Overall, two subpopulations were analysed: 138,481 patients who received BoNT-A injections between 2014 and 2020, and 318,025 patients who survived a stroke event between 2014 and 2016 and were followed up until 2020. Results: Among the 138,481 BoNT-A-treated patients, 53.5% received only one or two BoNT-A injections. Most of these patients (N = 85,900; 62.0%) received BoNT-A because they had CNS lesions. The number of patients with CNS lesions who received ≥1 BoNT-A injection increased by a mean of 7.5% per year from 2014 to 2019, but decreased by 0.2% between 2019 and 2020, corresponding to the COVID-19 outbreak. In stroke survivors (N = 318,025), 10.7% were coded with post-stroke spasticity, 2.3% received ≥1 BoNT-A injection between 2014 and 2020, and only 0.8% received ≥3 injections within the 12 months following BoNT-A treatment initiation, i.e., once every 3 to 4 months. Conclusion: Our analysis of the exhaustive PMSI database showed a suboptimal implementation of BoNT-A treatment recommendations in France. BoNT-A treatment initiation and re-administration are low, particularly in patients with post-stroke spasticity. Further investigations may help explain this observation, and may target specific actions to improve spasticity-related care pathway.