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1.
Michael W. O’Dell Allison Brashear Robert Jech Thierry Lejeune Philippe Marque Djamel Bensmail Ziyad Ayyoub David M. Simpson Magali Volteau Claire Vilain Philippe Picaut Jean Michel Gracies 《PM & R》2018,10(1):1-10
Background
AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited.Objective
To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS.Design
Secondary analysis of a phase 3 study (NCT01313299).Setting
Multicenter, international, double-blind, placebo-controlled clinical trial.Participants
A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose).Methods
The overall effects of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects.Main Outcome Measures
Angle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu Scale, and active range of motion (XA).Results
At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect.Conclusions
Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints.Level of Evidence
I 相似文献2.
Amanda McIntyre Magdalena Mirkowski Spencer Thompson Amer M. Burhan Tom Miller Robert Teasell 《PM & R》2018,10(3):293-302
Background
Spasticity is a common and potentially debilitating complication that develops after stroke, arising in approximately 30% of patients.Objective
To evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in improving spasticity after stroke.Design
Meta-analysis and systematic review.Setting
Not applicable.Patients
A total of 273 poststroke (hemorrhagic = 123, ischemic = 150) participants were included with sample sizes ranging from 5 to 80. The majority of participants were male (66.0%) with a mean age ranging from 55.0 to 64.6 years. Mean stroke duration ranged from 6 months to 10 years.Methods
A literature search of multiple databases was conducted for articles published in English from January 1980 to April 2015 using select keywords. Studies were included if (1) the population included was >50% stroke patients; (2) the sample size included ≥4 subjects; (3) the intervention applied was rTMS; and (4) upper extremity spasticity was assessed pre- and postintervention. Randomized controlled trials (RCTs) were assessed for methodologic quality with the Physiotherapy Evidence Database tool. All research designs were given a level of evidence according to a modified Sackett Scale.Main Outcome Measurements
Modified Ashworth Scale (MAS).Results
Ten studies met the inclusion criteria: 2 RCTs (Physiotherapy Evidence Database scores 8-9) and 8 pre-post studies. Meta-analyses of primarily uncontrolled pre-post studies found significant improvements in MAS for elbow (P < .001), wrist (P < .001), and finger flexors (P < .001). However, a meta-analysis of the 2 available RCTs failed to find a significant rTMS treatment effect on MAS for the wrist (standardized difference = .34, P = .30).Conclusions
There is limited available evidence to support the use of rTMS in improving spasticity poststroke. Despite the positive findings reported, better powered and appropriately controlled trials are necessary.Level of Evidence
II 相似文献3.
Bradley F. Thompson Matthew J. Pingree Wenchun Qu Naveen S. Murthy Nirusha Lachman Mark Friedrich Hurdle 《PM & R》2018,10(4):382-390
Background
Ultrasound is rarely used for guiding lumbosacral epidural steroid injections due to its technical limitations. For example, sonographic imaging lacks the ability to confirm epidural spread and identify vascular uptake. The perceived risk that these limitations pose to human subjects has precluded any large scale clinical trials to date.Objective
To compare the accuracy of ultrasound versus fluoroscopic guidance for first sacral transforaminal epidural injections.Design
Cadaveric comparative study using dichotomous outcomes.Setting
A fluoroscopy suite and anatomic laboratory at an academic medical center.Subjects
Four unembalmed adult human cadavers with no history of spinal surgery.Methods
Eight sites were injected twice by one interventionalist, using fluoroscopic and ultrasound guidance. In the fluoroscopy arm, contrast spread was assessed using computed tomography. In the ultrasound arm, latex spread was assessed using gross anatomic dissection. Any visible evidence of epidural spread constituted a positive result.Main Outcome Measurements
Comparison of the success of obtaining epidural contrast flow was the primary outcome measure. Secondary outcome measures included average duration, rate of intravascular uptake, and quantity of intravascular uptake.Results
All injections performed in both the ultrasound arm and the fluoroscopy arm had positive epidural spread. The average duration was 3.03 minutes with fluoroscopy and 4.76 minutes with ultrasound. The rate of intravascular uptake was 37.5% with fluoroscopy and 50% with ultrasound. Within the ultrasound arm, greater intravascular spread and duration variability were recorded.Conclusion
Although ultrasonography can provide reliable image guidance for cannulating the first sacral foramen in cadavers, it would have limited clinical utility due to its inability to visualize relevant neurovascular structures deep to the osseus roof and exclude intravascular uptake.Level of Evidence
IV 相似文献4.
Hyun-Mi Oh Geun-Young Park Young Min Choi Hyung Jung Koo Yongjun Jang Sun Im 《PM & R》2018,10(8):789-797
Background
There are no guidelines on the ideal time to inject botulinum toxin type A (BT-A) for lower leg spasticity in stroke patients. An early injection may produce unwanted weakness, interfering with gait recovery.Objective
To evaluate whether the outcomes after BT-A injection for plantarflexion spasticity can be different according to stroke chronicity.Design
A secondary analysis study from a double-blinded, randomized trial with group reclassification according to stroke chronicity.Setting
Two rehabilitation centers.Participants
Stroke participants (n = 40) with plantar flexor spasticity, treated with BT-A (200 units) into the gastrocnemius muscle.Methods
Outcome parameters were reanalyzed serially using 2-way repeated measures of analysis of variance (ANOVA), at baseline and 2, 4, and 8 weeks postinjection. Subjects were reclassified into 3 groups: early, within 6 months (n = 12); middle, between 6 months and 1 year (n = 14); and late, between 1 and 2 years from stroke onset (n = 12).Main Outcome Measures
The Modified Ashworth Scale, clonus scale, 10-m walking test, ABILOCO, and the Functional Ambulation Category.Results
The 2-way repeated measures of ANOVA showed improvement in gait and spasticity after injection in the 3 groups. Significant improvement in the Modified Ashworth Scale (P < .001) was observed, starting from the post–2 week injection period. Improvement of gait as assessed by the functional measurement ABILOCO and the Functional Ambulation Category (P < .001) were observed in all 3 groups, mostly at the post–8 week injection period.Conclusions
Our serial measurements of the outcome parameters indicated that BT-A could be expected to lead to consistent improvement in both the muscle tone and gait quality in those with plantar flexor spasticity regardless of stroke chronicity, including those injected as early as within the first 6 months.Level of Evidence
I 相似文献5.
Matthew J. McLaughlin Yang He Janice Brunstrom-Hernandez Liu Lin Thio Bruce C. Carleton Colin J.D. Ross Andrea Gaedigk Andrew Lewandowski Hongying Dai William J. Jusko J. Steven Leeder 《PM & R》2018,10(3):235-243
Background
Pharmacogenomic variability can contribute to differences in pharmacokinetics and clinical responses. Pediatric patients with cerebral palsy with genetic variations have not been studied for these potential differences.Objective
To determine the genetic sources of variation in oral baclofen clearance and clinical responses.Design
Pharmacogenomic add-on study to determine variability in oral baclofen clearance and clinical responses.Setting
Multicenter study based in academic pediatric cerebral palsy clinics.Participants
A total of 49 patients with cerebral palsy who had participated in an oral baclofen pharmacokinetic/pharmacodynamic study.Methods or Interventions
Of 53 participants in a pharmacokinetic/pharmacodynamic trial, 49 underwent genetic analysis of 307 key genes and 4535 single-nucleotide polymorphisms involved in drug absorption, distribution, metabolism, and excretion. Associations between genotypes and phenotypes of baclofen disposition (weight-corrected and allometrically scaled clearance) and clinical endpoints (improvement from baseline in mean hamstring Modified Tardieu Scale scores from baseline for improvement of R1 spastic catch) were determined by univariate analysis with correction for multiple testing by false discovery rate.Main Outcome Measurements
Primary outcome measures were the genotypic and phenotypic variability of oral baclofen in allometrically scaled clearance and change in the Modified Tardieu Scale angle compared to baseline.Results
After univariate analysis of the data, the SNP of ABCC9 (rs11046232, heterozygous AT versus the reference TT genotype) was associated with a 2-fold increase in oral baclofen clearance (mean 0.51 ± standard deviation 0.05 L/h/kg for the AT genotype versus 0.25 ± 0.07 L/h/kg for the TT genotype, adjusted P < .001). Clinical responses were associated with decreased spasticity by Modified Tardieu Scale in allelic variants with SNPs ABCC12, SLC28A1, and PPARD.Conclusions
Genetic variation in ABCC9 affecting oral baclofen clearance highlights the need for continued studies of genetic polymorphisms to better characterize variable drug response in children with cerebral palsy. Single-nucleotide polymorphisms in ABCC12, SLC28A1, and PPARD were associated with varied responses, which warrants further investigation to determine their effect on spasticity.Level of Evidence
II 相似文献6.
Yah-Ting Wu Hui-Kung Yu Li-Ru Chen Chih-Ning Chang Yi-Min Chen Gwo-Chi Hu 《Archives of physical medicine and rehabilitation》2018,99(11):2143-2150
Objective
To investigate whether extracorporeal shock wave therapy (ESWT) is noninferior to botulinum toxin type A (BoNT-A) for the treatment of poststroke upper limb spasticity.Design
Randomized noninferiority trial.Setting
Referral medical center.Participants
Patients (N=42) with chronic stroke (28 men; mean age, 61.0±10.6y).Interventions
Patients received either ESWT or BoNT-A. During the study period, all patients continued their regular rehabilitation.Main Outcome Measures
Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome was the change from baseline of the modified Ashworth scale (MAS) score of the wrist flexors at week 4. Secondary outcomes included the change of the MAS scores, Tardieu angles of the wrist and elbow flexors, wrist and elbow passive range of motion (PROM), and upper extremity Fugl-Meyer Assessment (UE-FMA) score during the study period, as well as the treatment response rate.Results
The primary outcome result in the ESWT group (?0.80±0.41) was similar to that in the BoNT-A group (?0.90±0.44), with a higher confidence limit (0.4) for the difference between groups within the prespecified margin of 0.5, indicating the noninferiority of ESWT to BoNT-A. The response rate was not significantly different between the 2 groups. Both groups showed significant improvement in secondary outcomes relative to baseline; however, the ESWT group yielded greater improvement in wrist and elbow PROM and UE-FMA score.Conclusion
Our results suggest that ESWT is a noninferior treatment alternative to BoNT-A for poststroke upper limb spasticity. ESWT and BoNT-A caused similar reduction in spasticity of the wrist and elbow flexors; however, ESWT yielded greater improvement in wrist and elbow PROM and UE-FMA score. 相似文献7.
Matthew J. Miller Dawn M. Magnusson Guy Lev Thomas T. Fields Paul F. Cook Jennifer E. Stevens-Lapsley Cory L. Christiansen 《PM & R》2018,10(10):1056-1061
Background
Prosthesis rehabilitation after dysvascular transtibial amputation (TTA) is focused on optimizing functional capacity with limited emphasis on promoting health self-efficacy. Self-efficacy interventions decrease disability for people living with chronic disease, but the influence of self-efficacy on disability is unknown for people with dysvascular TTA.Objectives
To identify if self-efficacy mediates the relationship between self-reported functional capacity and disability after dysvascular TTA.Design
Cross-sectional, secondary data analysis.Setting
Outpatient rehabilitation facilities.Participants
Thirty-eight men (63.6 ± 9.1 years old) with dysvascular TTA.Methods
Participants had been living with an amputation for less than 6 months and using walking as their primary form of locomotion using a prosthesis. The independent variable, functional capacity, was measured using the Prosthesis Evaluation Questionnaire–Mobility Scale (PEQ-MS). The proposed mediator, self-efficacy, was measured with the Self-Efficacy of Managing Chronic Disease questionnaire (SEMCD).Main Outcome Measure
Disability was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire.Results
The relationship between self-reported functional capacity and disability is partially mediated by self-efficacy. Relationships between WHODAS 2.0 and PEQ-MS (r = –0.61), WHODAS 2.0 and SEMCD (r = –0.51), and PEQ-MS and SEMCD (r = 0.44) were significant (P < .01). Controlling for SEMCD (P = .04), the relationship between PEQ-MS and WHODAS 2.0 remained significant (P < .01). Statistically significant mediation was determined by a bootstrap method for the product of coefficients (95% confidence interval: –2.23, –7.39).Conclusions
This study provides initial evidence that the relationship between self-reported functional capacity and disability is partially mediated by self-efficacy after dysvascular TTA. The longitudinal effect of self-efficacy should be further examined to identify causal pathways of disability after dysvascular amputation. Furthermore, additional factors contributing to the relationship between self-reported functional capacity and disability need to be identified.Level of Evidence
III 相似文献8.
Alberto Esquenazi Abraham Alfaro Ziyad Ayyoub David Charles Khashayar Dashtipour Glenn D. Graham John R. McGuire Ib R. Odderson Atul T. Patel David M. Simpson 《PM & R》2017,9(10):960-968
Background
OnabotulinumtoxinA is approved for the treatment of upper and lower limb spasticity in adults. Guidance on common postures and onabotulinumtoxinA injection paradigms for upper limb spasticity has been developed via a Delphi Panel; however, similar guidance for lower limb spasticity has not been established.Objective
To define a clinically recommended treatment paradigm for the use of onabotulinumtoxinA for each common posture among patients with poststroke lower limb spasticity (PSLLS) and to identify the most common PSLLS aggregate postures.Design
Clinical experts provided insight regarding onabotulinumtoxinA treatment for PSLLS using an adaptation of the Delphi consensus process.Setting
Delphi panel.Participants
Ten expert clinicians in neurology and physical medicine and rehabilitation who treat PSLLS.Methods
A minimum of 2 rounds of anonymous voting occurred for each recommendation until consensus was reached (≥66% agreement). The first round was conducted via a survey; the second round was an in-person meeting.Main Outcome Measurements
Reached consensus on muscle selection for injection, overall and per-muscle dose of onabotulinumtoxinA, number of injection sites/muscle, onabotulinumtoxinA dilution, and use of localization techniques. The most common PSLLS postures were reviewed. Recommendations were tailored toward injectors with less experience.Results
Consensus was reached on targeted subsets of muscles for each posture. Doses ranged from 20 to 150 U for individual muscles and 50 to 300 U for limb postures. OnabotulinumtoxinA dilution 50 U/mL (2:1 ratio) was considered most appropriate but varied based on muscles selected (range, 2:1-4:1). Experts agreed that localization techniques for muscle identification during injection for all postures would be useful. For suboptimal response to injection, all panel members would increase the dose, and the majority (89%) would increase the number of treated muscles. The panel identified 3 common aggregating lower limb postures: (1) equinovarus foot and flexed toes; (2) extended knee and plantar flexed foot/ankle; and (3) plantar flexed foot/ankle and flexed toes. The recommended starting doses for each aggregate posture were 400 U, 400 U, and 300 U, respectively.Conclusion
The modified Delphi panel process provided consensus on common muscles and corresponding onabotulinumtoxinA treatment paradigms for postures associated with PSLLS that can be used for guidance in optimizing care delivery.Level of Evidence
V 相似文献9.
Jacob G. McPherson Arno H. Stienen Justin M. Drogos Julius P. Dewald 《Archives of physical medicine and rehabilitation》2018,99(3):491-500
Objective
To systematically characterize the effect of flexion synergy expression on the manifestation of elbow flexor stretch reflexes poststroke, and to relate these findings to elbow flexor stretch reflexes in individuals without neurologic injury.Design
Controlled cohort study.Setting
Academic medical center.Participants
Participants (N=20) included individuals with chronic hemiparetic stroke (n=10) and a convenience sample of individuals without neurologic or musculoskeletal injury (n=10).Interventions
Participants with stroke were interfaced with a robotic device that precisely manipulated flexion synergy expression (by regulating shoulder abduction loading) while delivering controlled elbow extension perturbations over a wide range of velocities. This device was also used to elicit elbow flexor stretch reflexes during volitional elbow flexor activation, both in the cohort of individuals with stroke and in a control cohort. In both cases, the amplitude of volitional elbow flexor preactivation was matched to that generated involuntarily during flexion synergy expression.Main Outcome Measures
The amplitude of short- and long-latency stretch reflexes in the biceps brachii, assessed by electromyography, and expressed as a function of background muscle activation and stretch velocity.Results
Increased shoulder abduction loading potentiated elbow flexor stretch reflexes via flexion synergy expression in the paretic arm. Compared with stretch reflexes in individuals without neurologic injury, paretic reflexes were larger at rest but were approximately equal to control muscles at matched levels of preactivation.Conclusions
Because flexion synergy expression modifies stretch reflexes in involved muscles, interventions that reduce flexion synergy expression may confer the added benefit of reducing spasticity during functional use of the arm. 相似文献10.
Ryan Woods Steve J. Wisniewski Daniel R. Lueders Thomas P. Pittelkow Dirk R. Larson Jonathan T. Finnoff 《PM & R》2018,10(7):730-737
Background
Accurate diagnosis of musculoskeletal disorders relies heavily on the physical examination, including accurate palpation of musculoskeletal structures. The literature suggests that there has been a deterioration of physical examination skills among medical students and residents, in part due to increased reliance on advanced imaging. It has been shown that knowledge of musculoskeletal anatomy and physical examination skills improve with the use of ultrasound; however, the literature is limited.Objective
To determine whether ultrasound can improve the ability of physicians in training (residents) to palpate the long head of the biceps tendon (LHBT) in the bicipital groove.Design
Prospective study design.Setting
Tertiary care center.Participants
Ten physical medicine and rehabilitation residents served as subjects. Exclusion criteria included the presence of any condition that precluded their ability to palpate. Three volunteers were used as models. Model exclusion criteria included anything that distorted normal shoulder anatomy or inhibited examiner palpation. Three investigators with experience performing diagnostic musculoskeletal ultrasound were used to confirm palpation attempts.Methods
Subjects attempted to palpate the LHBT bilaterally in the bicipital groove of each model. Investigators assessed the accuracy of the palpation attempt using real-time ultrasonography. Subjects participated in a 30-minute ultrasound-assisted training session learning how to palpate the LHBT in the bicipital groove with ultrasound confirmation. After the ultrasound training session, subjects again attempted to palpate the LHBT in the bicipital groove of each model with investigator confirmation.Main Outcome Measurements
LHBT palpation accuracy rates preintervention versus postintervention.Results
Pretraining LHBT palpation accuracy was 20% (12/60 attempts). Post-ultrasound training session accuracy was 51.7% (31/60 attempts; P ≤ .001).Conclusions
Our findings demonstrate that palpation accuracy improves after ultrasound assisted LHBT palpation training. These data suggest that the use of ultrasound may be beneficial when teaching musculoskeletal palpation skills to health care professionals.Level of Evidence
II 相似文献11.
Anneleen Malfliet Jeroen Kregel Mira Meeus Lieven Danneels Barbara Cagnie Nathalie Roussel Jo Nijs 《PM & R》2018,10(12):1330-1343.e1
Background
Pain neuroscience education is effective in chronic pain management. Central sensitization (ie, generalized hypersensitivity) is often explained as the underlying mechanism for chronic pain, because of its clinical relevance and influence on pain severity, prognosis, and treatment outcome.Objectives
To examine whether patients with more or fewer symptoms of central sensitization respond differently to pain neuroscience education.Design
A secondary analysis of a multicenter, triple-blind randomized controlled trial.Setting
University Hospital Ghent and University Hospital Brussels, Belgium.Patients
120 persons with chronic spinal pain with high or low self-reported symptoms of central sensitization.Interventions
Pain neuroscience education or neck/back school. Both interventions were delivered in 3 sessions: 1 group session, 1 online session, and 1 individual session.Main Outcome Measures
disability (primary), pain catastrophizing, kinesiophobia, illness perceptions, and hypervigilance.Results
Pain disability did not change in any group (P = .242). Regarding secondary outcomes: significant interaction effects were found for pain catastrophizing (P-values: P = .02 to P = .05), kinesiophobia (P = .02), and several aspects of illness perceptions (chronicity: P = .002; negative consequences: P = .02; personal control: P = .02; and cyclicity: P = .02). Bonferroni post hoc analysis showed that only the pain neuroscience education group (high and low self-reported symptoms of central sensitization) showed a significant improvement regarding kinesiophobia (P < .001, medium effect sizes), perceived negative consequence (P = .004 and P < .001, small to medium effect sizes), and perceived cyclicity of the illness (P = .01 and P = .01, small effect sizes). Pain catastrophizing only significantly reduced in people with high self-reported central sensitization symptoms (P < .05).Conclusion
Pain neuroscience education is useful in all patients with chronic spinal pain as it improves kinesiophobia and the perceived negative consequences and cyclicity of the illness regardless the self-reported signs of central sensitization. Regarding pain catastrophizing, pain neuroscience education is more effective in patients with high self-reported symptoms of central sensitization.Level of Evidence
I 相似文献12.
13.
Background
As our population ages, neurogenic claudication (NC) from central canal stenosis of the lumbar spine is becoming an increasingly common condition. Studies have been undertaken to assess the efficacy of caudal, interlaminar, or unilateral transforaminal epidural injections, but bilateral transforaminal epidural injections (BTESIs) have not been evaluated to date.Objective
To assess the therapeutic value and long-term effects of fluoroscope-guided BTESIs in patients with NC from degenerative lumbar spinal stenosis (DLSS) of the central spinal canal.Design
Case series.Setting
Single institution spine clinic.Patients
Twenty-six adults between the ages of 40 and 90 years with a diagnosis of DLSS and a history of subacute or chronic NC.Methods/Interventions
Patients meeting inclusion criteria received fluoroscope-guided BTESI of local anesthetic and steroid at the level immediately below the most stenotic level. Patient self-reported pain level, activity level, and overall satisfaction were recorded by telephone interview at 1, 3, and 6 months after injection by an independent observer.Main Outcome Measures
Pain score and Swiss Spinal Stenosis score at baseline, 1, 3, and 6 months.Results
Of the 22 participants eligible for analysis, 20, 19, and 18 had follow-up data available at 1, 3, and 6 months, respectively. Reduction in numeric pain scale score of at least 50% was noted in 30% of participants at 1 month, 53% at 3 months, and 44% at 6 months. Swiss Spinal Stenosis subscale scores indicated a significant reduction in the proportion of participants reporting the presence of severe pain in the back, buttocks, and legs (particularly the back or buttocks) at 1, 3, and 6 months of follow-up compared with baseline (P < .05). The proportion of participants reporting severe weakness in the legs or feet also decreased after injection and was statistically significant at 3 months of follow-up (P = .04).Conclusions
Fluoroscope-guided BTESI was moderately effective in reducing pain, improving function, and achieving patient satisfaction in patients with NC from DLSS at the central spinal canal in this clinical case series.Level of Evidence
IV 相似文献14.
Flora M. Hammond William Sauve Fred Ledon Charles Davis Andrea E. Formella 《PM & R》2018,10(10):993-1003
Background
Dextromethorphan 20 mg / quinidine 10 mg (DM/Q) was approved to treat pseudobulbar affect (PBA) based on phase 3 trials conducted in participants with amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness, safety, and tolerability for PBA following stroke, dementia, or traumatic brain injury (TBI).Objective
To report results from the TBI cohort of PRISM II, including a TBI-specific functional scale.Design
Open-label trial evaluating twice-daily DM/Q over 90 days.Study Participants
Adults (n = 120) with a clinical diagnosis of PBA secondary to nonpenetrating TBI; stable psychiatric medications were allowed.Methods
PRISM II was an open-label, 12-week trial enrolling adults with PBA secondary to dementia, stroke, or TBI (NCT01799941). All study participants received DM/Q 20/10 mg twice daily. Study visits occurred at baseline and at day 30 and day 90.Setting
150 U.S. centers.Main Outcome Measurements
Primary endpoint was change in Center for Neurologic Study–Lability Scale (CNS-LS) score from baseline to day 90. Secondary outcomes included PBA episode count, Clinical and Patient Global Impression of Change (CGI-C; PGI-C), Quality of Life–Visual Analog Scale (QOL-VAS), treatment satisfaction, Neurobehavioral Functioning Inventory (NFI), Patient Health Questionnaire (PHQ-9), and Mini Mental State Examination (MMSE).Results
DM/Q-treated participants showed significant mean (SD) reductions in CNS-LS from baseline (day 30, –5.6 [5.2]; day 90, –8.5 [5.2]; both, P<.001). Compared with baseline, PBA episodes were reduced by 61.3% and 78.5% at days 30 and 90 (both, P<.001). At day 90, 78% and 73% of study participants had “much improved” or “very much improved” on the CGI-C and PGI-C. QOL-VAS scores were significantly reduced from baseline (–3.7 [3.3], P<.001). Mean (SD) PHQ-9 scores improved compared to baseline at day 30 (–3.2 [5.3], P<.001) and 90 (–5.2 [6.4], P<.001). NFI T scores were significantly improved (P<.001), whereas MMSE scores were unchanged. Adverse events (AEs) were consistent with the known DM/Q safety profile; the most common AE was diarrhea (8.3%).Conclusions
DM/Q was well tolerated, and it significantly reduced PBA episodes in study participants with TBI. Changes in CNS-LS and PBA episode count were similar to changes with DM/Q in phase 3 trials.Level of Evidence
II 相似文献15.
Nobushige Takahashi Hidetoshi Takahashi Osamu Takahashi Ryosuke Ushijima Rie Umebayashi Junji Nishikawa Yasutomo Okajima 《PM & R》2018,10(2):168-174
Background
Spasticity is a common sequela of upper motor neuron pathology, such as cerebrovascular diseases and cerebral palsy. Intervention for spasticity of the ankle plantarflexors in physical therapy may include tone-inhibiting casting and/or orthoses for the ankle and foot. However, the physiological mechanism of tone reduction by such orthoses remains unclarified.Objective
To investigate the electrophysiologic effects of tone-inhibiting insoles in stroke subjects with hemiparesis by measuring changes in reciprocal Ia inhibition (RI) in the ankle plantarflexor.Design
An interventional before–after study.Setting
Acute stroke unit or ambulatory rehabilitation clinic of a university hospital in Japan.Participants
Ten subjects (47-84 years) with hemiparesis and 10 healthy male control subjects (31-59 years) were recruited.Methods
RI of the spastic soleus in response to the electrical stimulation of the deep peroneal nerve was evaluated by stimulus-locked averaging of rectified electromyography (EMG) of the soleus while subjects were standing.Main Outcome Measurements
The magnitude of RI, defined as the ratio of the lowest to the baseline amplitude of the rectified EMG at approximately 40 milliseconds after stimulation, was measured while subjects were standing with and without the tone-inhibiting insole on the hemiparesis side.Results
Enhancement of EMG reduction with the tone-inhibiting insole was significant (P < .05) in the subjects with hemiparesis, whereas no significant changes were found in controls.Conclusion
Tone-inhibiting insoles enhanced RI of the soleus in subjects after stroke, which might enhance standing stability by reducing unfavorable ankle plantarflexion tone.Level of Evidence
III 相似文献16.
Brittany Bickelhaupt Sakiko Oyama Jonathan Benfield Keith Burau Shuko Lee Michelle Trbovich 《PM & R》2018,10(10):1004-1011
Background
Shoulder dysfunction is common in persons with spinal cord injury (SCI) with an incidence of up to 63%. Dysfunction is a result of muscle imbalances, specifically denervated rotator cuff muscles that are repetitively used during manual wheelchair propulsion.Objective
To determine which arm stroke technique, pump (P) or semicircular (SC), is most energy efficient for long periods of propulsion.Design
A randomized study with repeated measures observations.Setting
The study was performed at an institutional gait analysis laboratory.Participants
18 able-bodied (AB) male participants were studied and randomized into one of 2 conditions, SC or P.Methods
Shoulder muscle fatigue was measured by changes in Borg CR10 Rate of Perceived Exertion (Borg RPE) and upper extremity strength via a handheld dynamometer. Participants were studied and assigned into one of 2 conditions of wheelchair arm propulsion patterns, SC or P group, and propelled on a wheelchair treadmill for 10 minutes.Main Outcome Measures
The primary outcomes included recordings of Borg RPE scale during continuous wheelchair propulsion and pre- and post-test dynamometer testing means for bilateral elbow and shoulder extension. Analysis of covariance, t-tests, and Kruskal-Wallis tests were used in analyzing data.Results
Although not significant (P = .23), the Borg RPE scores for the SC condition were consistently higher than the scores for the P condition. In addition, the dynamometer pre- and post-test readings demonstrated a larger decrease for the SC condition participants than for the P condition participants, but were not statistically significant.Conclusions
These data demonstrate that the SC wheelchair propulsion pattern appears to be more fatiguing to shoulder muscles than the P propulsion pattern. However, more data would need to be collected to find a significant difference.Level of Evidence
II 相似文献17.
Donna Bergman Lynnette Rasmussen Kate Wan-Chu Chang Lynda J-S. Yang Virginia S. Nelson 《PM & R》2018,10(1):64-71
Background
The term self-determination refers to decision-making, goal setting, and perseverance to achieve those goals. Numerous studies have established the importance of self-determination to enhance learning and improve postschool outcomes. However, most studies evaluate students with learning disabilities, cognitive impairment, or behavioral disabilities. There is an absence of research on self-determination for adolescents with physical disabilities.Objective
To assess self-determination of adolescents with neonatal brachial plexus palsy (NBPP) compared with their typically developing peers via self-reported measures of function.Design
Case-control study.Setting
Brachial plexus clinic.Participants
Twenty adolescents with NBPP (aged 10-17 years) and their parents and 20 age/gender-matched typically developing adolescents and their parents were recruited. Non–English-speaking participants and those with other physical impairments were excluded from study.Methods
Participants completed demographic and American Institutes for Research (AIR) self-determination surveys. One of two designated occupational therapists evaluated participant physical function.Main Outcome Measurements
A demographic survey and AIR self-determination assessment were administered, and active range of motion measurements in shoulder forward flexion, elbow flexion, elbow extension, forearm pronation, and supination were obtained. Grip/pinch strength, MRC muscle strength, 9-Hole Peg Test, and Mallet scale scores also were evaluated.Results
Despite physical differences, adolescents with NBPP presented similar self-determination levels as their typically developing peers. Adolescents with NBPP rated their opportunities to engage in self-determined behaviors at school significantly lower than at home. Both adolescents with NBPP and those in the control group rated their opportunities to engage in self-determined behaviors at school significantly lower than at home.Conclusions
Adolescents with NBPP presented similar self-determination scores as their age/gender-matched typically developing peers. These results could be a reflection of our program’s patient- and family-centered care approach. Therefore, caregivers and providers should encourage personal development and fulfillment in adolescents with NBPP. Teachers and schools should be aware that opportunities for acquiring self-determination skills might be more limited at school than at home in this age group.Level of Evidence
III 相似文献18.
Theodore Wein Alberto Esquenazi Wolfgang H. Jost Anthony B. Ward Grace Pan Rozalina Dimitrova 《PM & R》2018,10(7):693-703
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 相似文献19.
Gregory E. Lutz Michael R. Nicoletti George E. Cyril Julian R. Harrison Christopher Lutz Jennifer L. Solomon Paul M. Cooke James F. Wyss Richard J. Herzog Peter J. Moley 《PM & R》2018,10(3):245-253
Background
Although lumbar zygapophyseal joint synovial cysts are fairly well recognized, they are an uncommon cause of lumbosacral radicular pain. Nonoperative treatments include percutaneous aspiration of the cysts under computed tomography or fluoroscopic guidance with a subsequent corticosteroid injection. However, there are mixed results in terms of long-term outcomes and cyst reoccurrence. This study prospectively evaluates percutaneous ruptures of zygapophyseal joint (Z-joint) synovial cysts for the treatment of lumbosacral radicular pain.Objectives
Primary: To determine whether percutaneous rupture of symptomatic Z-joint synovial cysts leads to sustained improvements in radicular pain and function. Secondary: To assess the rates of cyst recurrence and progression to surgical intervention following percutaneous rupture of symptomatic Z-joint synovial cysts.Design
Prospective cohort study.Setting
Outpatient academic spine practice.Participants
Adults with primary radicular pain due to a facet synovial cyst.Methods
Participants underwent fluoroscopically guided percutaneous Z-joint synovial cyst ruptures under standard-of-care practice. Data on pain, physical function, satisfaction, and progression to surgery were collected at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after rupture. An intention-to-treat analysis was used for assessment of patient-reported outcome measures.Main Outcome Measures
The Numerical Rating Scale, Oswestry Disability Index, and modified North American Spine Society questionnaires were used to measure pain, function, and satisfaction with the procedure, respectively.Results
Thirty-five participants were included in the study, and data were analyzed by an independent researcher. Statistically significant changes in Oswestry Disability Index were reported at 2 weeks, 3 months, and 1 year postintervention (P = .034, .040, and .039, respectively). A statistically and clinically significant relief of current pain was reported at 2 weeks (P = .025) and 6 weeks (P = .014) with respect to baseline. Patients showed significant improvements for best pain at 6 weeks with respect to baseline (P = .031). Patients’ worst pain showed the greatest amount of improvement with clinically meaningful changes at all time points compared with baseline. Patient-reported satisfaction was found nearly 70% of the time at all time points. Forty percent (14/35) of participants required repeat cyst rupture, and 31% (11/35) required surgical interventions.Conclusions
There were statistically and clinically significant improvements in pain and function after percutaneous rupture of Z-joint synovial cysts. In addition, the outcomes support previous retrospective studies indicating that approximately 40% of patients will need surgery. This study provides further research to determine the utility of this procedure and to precisely define a subset of ideal candidates.Level of Evidence
Level II. 相似文献20.
Rana Terlemez Figen Yilmaz Beril Dogu Banu Kuran 《Archives of physical medicine and rehabilitation》2018,99(1):116-120