scholarly journals Allowing Intralimb Kinematic Variability During Locomotor Training Poststroke Improves Kinematic Consistency: A Subgroup Analysis From a Randomized Clinical Trial

2009 ◽  
Vol 89 (8) ◽  
pp. 829-839 ◽  
Author(s):  
Michael D. Lewek ◽  
Theresa H. Cruz ◽  
Jennifer L. Moore ◽  
Heidi R. Roth ◽  
Yasin Y. Dhaher ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Small Sample Size ◽  
Gait Pattern ◽  
Small Sample ◽  
Lower Limbs ◽  
Walking Ability ◽  
Locomotor Training ◽  
Robotic Assisted ◽  
Robotic Devices

BackgroundLocomotor training (LT) to improve walking ability in people poststroke can be accomplished with therapist assistance as needed to promote continuous stepping. Various robotic devices also have been developed that can guide the lower limbs through a kinematically consistent gait pattern. It is unclear whether LT with either therapist or robotic assistance could improve kinematic coordination patterns during walking.ObjectiveThe purpose of this study was to determine whether LT with physical assistance as needed was superior to guided, symmetrical, robotic-assisted LT for improving kinematic coordination during walking poststroke.DesignThis study was a randomized clinical trial.MethodsNineteen people with chronic stroke (>6 months’ duration) participating in a larger randomized control trial comparing therapist- versus robotic-assisted LT were recruited. Prior to and following 4 weeks of LT, gait analysis was performed at each participant's self-selected speed during overground walking. Kinematic coordination was defined as the consistency of intralimb hip and knee angular trajectories over repeated gait cycles and was compared before and after treatment for each group.ResultsLocomotor training with therapist assistance resulted in significant improvements in the consistency of intralimb movements of the impaired limb. Providing consistent kinematic assistance during robotic-assisted LT did not result in improvements in intralimb consistency. Only minimal changes in discrete kinematics were observed in either group.LimitationsThe limitations included a relatively small sample size and a lack of quantification regarding the extent of movement consistency during training sessions for both groups.ConclusionsCoordination of intralimb kinematics appears to improve in response to LT with therapist assistance as needed. Fixed assistance, as provided by this form of robotic guidance during LT, however, did not alter intralimb coordination.

Multicenter Randomized Clinical Trial Evaluating the Effectiveness of the Lokomat in Subacute Stroke

2008 ◽  
Vol 23 (1) ◽  
pp. 5-13 ◽  
Author(s):  
Joseph Hidler ◽  
Diane Nichols ◽  
Marlena Pelliccio ◽  
Kathy Brady ◽  
Donielle D. Campbell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Walking Speed ◽  
Gait Training ◽  
Secondary Outcome ◽  
Walking Ability ◽  
Robotic Assisted ◽  
Subacute Stroke

Objective. To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke. Methods. A total of 63 participants <6 months poststroke with an initial walking speed between 0.1 to 0.6 m/s completed the multicenter, randomized clinical trial. All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training. Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up exam. Self-selected overground walking speed and distance walked in 6 minutes were the primary outcome measures, whereas secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures. Results. Participants who received conventional gait training experienced significantly greater gains in walking speed ( P = .002) and distance ( P = .03) than those trained on the Lokomat. These differences were maintained at the 3-month follow-up evaluation. Secondary measures were not different between the 2 groups, although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group. Conclusions. For subacute stroke participants with moderate to severe gait impairments, the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability.

Essential tremor: genetic update

2019 ◽  
Vol 21 ◽  
Author(s):  
Hao Deng ◽  
Shan Wu ◽  
Joseph Jankovic
Keyword(s):  
Essential Tremor ◽  
Animal Studies ◽  
Genetic Factors ◽  
Small Sample Size ◽  
Small Sample ◽  
Lower Limbs ◽  
Body Parts ◽  
Genetic Analyses ◽  
Disease Definition ◽  
Neurological Movement Disorder

Abstract Essential tremor (ET) is a neurological movement disorder characterised by bilateral limb kinetic/postural tremor, with or without tremor in other body parts including head, voice and lower limbs. Since no causative genes for ET have been identified, it is likely that the disorder occurs as a result of complex genetic factors interacting with various cellular and environmental factors that can result in abnormal function of circuitry involving the cerebello–thalamo–cortical pathway. Genetic analyses have uncovered at least 14 loci and 11 genes that are related to ET, as well as various risk or protective genetic factors. Limitations in ET genetic analyses include inconsistent disease definition, small sample size, varied ethnic backgrounds and many other factors that may contribute to paucity of relevant genetic data in ET. Genetic analyses, coupled with functional and animal studies, have led to better insights into possible pathogenic mechanisms underlying ET. These genetic studies may guide the future development of genetic testing and counselling, and specific, pathogenesis-targeted, therapeutic strategies.

Salvage chemotherapy in the treatment of metastatic melanoma after progression on immunotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22019-e22019
Author(s):  
Payal Shah ◽  
Patrick Boland ◽  
Anna C. Pavlick
Keyword(s):  
Clinical Trial ◽  
Metastatic Melanoma ◽  
Retrospective Analysis ◽  
Checkpoint Inhibitors ◽  
Small Sample Size ◽  
Single Agent ◽  
Complete Response ◽  
Salvage Chemotherapy ◽  
Small Sample ◽  
Clinical Trial Evidence

e22019 Background: Immune-checkpoint inhibitors (ICI) have dramatically altered the prognosis of metastatic melanoma (MM); however, fifty percent of patients will not respond to ICI. For these patients, the next choice of treatment includes targeted therapy or a clinical trial if eligible. If these treatment choices have already been utilized or are not available to the patient, there may be value in attempting a course of salvage chemotherapy (CTX). Limited clinical trial evidence has demonstrated unexpected efficacy of CTX after prior progression on ipilimumab, offering higher disease control rates than expected from what is seen in first-line chemotherapy. The phenomenon of a “priming” effect of ICI on CTX efficacy has been shown in patients of various solid tumors after progression on anti-PD1/PD-L1 therapy. The purpose of this retrospective analysis is to evaluate the efficacy of salvage CTX after prior ICI therapy for patients with MM. Patients with ocular melanoma were excluded, as this tumor subtype is known to have reduced response to immunotherapy. Methods: By retrospective analysis, patients were included under an IRB approved waiver of consent. We identified patients with MM treated with ICI therapy between Jan, 2011 and July, 2019 who were subsequently treated with salvage CTX as a result of progression of disease (POD). Salvage CTX included dacarbazine, carboplatin, temozolomide, paclitaxel, or a combination. We assessed response rate, duration of response, and time to progression (TTP) from the onset of salvage CTX. Results: A total of 22 patients who satisfied the above criteria were identified. The majority of this population had a course of single agent ICI as well as a course of combination ICI prior to salvage CTX (72.7%, n = 16/22). 13 (59.1%) patients had POD on salvage CTX with a median TTP of 10.9 weeks. 9 (40.9%) patients responded to salvage CTX. 3 (13.6%) patients achieved a complete response, 4 (18.2%) patients achieved a partial response and 2 (9.1%) patients achieved stable disease. Mean durability of response was 53.6 weeks, ranging from 7-194 weeks. Conclusions: ICI “priming” prior to salvage CTX efficacy may improve disease responsiveness to CTX. This sequence of therapy may offer patients another reasonable treatment option. Despite the small sample size of this study, a prospective clinical trial in MM exploring CTX following ICI progression should be considered.

scholarly journals Modulation of Cardiac Injury by ACE inhibitor/ARB in Patients with Severe COVID-19

2020 ◽  
Author(s):  
Beibei Du ◽  
Daoyuan Si ◽  
Bo Yang ◽  
Guohui Liu ◽  
Qian Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Small Sample Size ◽  
Cardiac Injury ◽  
Ventilatory Support ◽  
Small Sample ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference ◽  
Ctni Level

Abstract Introduction: Cardiac injury occurs in 7-22% of patient hospitalized with COVID-19 and an elevation in troponin is associated with a 4.2-fold increase in the risk of mortality. Preliminary data showed ACEi/ARB usage might not increase mortaily in COVID-19 patients. However, it is unknown if cardiac injury in patients with severe COVID-19 can be modulated by ACEi/ARB usage during evolution of the cardiac injury.Methods: In 154 COVID-19 patients with cardiac injury, the effect of ACEi/ARB treatment (17 patients) was compared with 137 patients without ACEi/ARB treatment. Cardiac injury was indicated by cTnI level.Results: In ACEi/ARB treatment group and no ACEi/ARB treatment group, peak cTnI level did not show significant difference (150.5 pg/ml [31.75-1179], vs 207 pg/ml [54.65-989.4], respectively, P = 0.21). Evolution of Cardiac injury (temporal change of cTnI at day 6, 9, 12, 15, 18, 21, 24, 27, 30, and 33) showed no statistical difference. Mortality (ACEi/ARB group vs no ACEi/ARB group; 52.9% vs 69.9%, P = 0.17), atrial arrhythmias (11.7% vs 24.4%, P = 0.36), requirement for invasive ventilatory support (29.4% vs 48.2%, P = 0.14) also showed no significant difference in two groups.Conclusions: ACEi/ARB usage during the COVID-19 was not associated with exacerbation of cardiac injury. These data should be interpreted as essentially hypothesis-generating due to small sample size.Clinical Trial Registration: This retrospective study was registered in Chinese clinical trial registry (ChiCTR 2000031301).

scholarly journals Unification of treatments and interventions for tinnitus patients (UNITI): a study protocol for a multi-center randomized clinical trial

2021 ◽  
Author(s):  
Stefan Schoisswohl ◽  
Berthold Langguth ◽  
Martin Schecklmann ◽  
Benjamin Boecking ◽  
Christopher Cederroth ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Hearing Aids ◽  
Behavioral Therapy ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Personalized Treatment ◽  
Treatment Approaches ◽  
Multiple Systems ◽  
Small Sample Sizes

Abstract Background Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments or applications of intervention targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI-project). Methods/ Study design: This is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counselling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. Discussion Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus. Trial registration: ClinicalTrials.gov: NCT04663828. Registered on 11. December 2020

scholarly journals Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Esther Fernandes Tinoco Volpe ◽  
Vanessa R. Resqueti ◽  
Ana Aline Marcelino da Silva ◽  
Lucien Peroni Gualdi ◽  
Guilherme A. F. Fregonezi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Exercise Program ◽  
Calf Muscle ◽  
Lower Limbs ◽  
Muscle Endurance ◽  
Randomized Controlled ◽  
Supervised Exercise ◽  
Supervised Exercise Program ◽  
Calf Muscles

Abstract Background Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI. Methods/design This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks’ intervention. Discussion Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence. Trial registration This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.

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