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In patients with idiopathic normal-pressure hydrocephalus responsive to CSF drainage, shunting improved gait and balance at 3 months, but not cognition or incontinence, and was associated with some procedure-related risks.

Hereditary transthyretin amyloidosis is caused by the deposition of misfolded transthyretin proteins in peripheral nerves and other tissues. This phase 3 trial tested patisiran, a small interfering RNA targeting transthyretin messenger RNA, to treat the disease.

In a randomized, sham-controlled trial involving 40 patients, therapeutic lesions on one side in the subthalamic nucleus were produced by focused ultrasound. At 4 months, motor performance was better in the active-treatment group. Twelve patients had neurologic deficits, many of which resolved by 12 months.

Falls are a frequent and serious complication of Parkinson's disease and are related partly to an underlying cholinergic deficit that contributes to gait and cognitive dysfunction in these patients. Gait dysfunction can lead to an increased variability of gait from one step to another, raising the likelihood of falls. In the ReSPonD trial we aimed to assess whether ameliorating this cholinergic deficit with the acetylcholinesterase inhibitor rivastigmine would reduce gait variability. We did this randomised, double-blind, placebo-controlled, phase 2 trial at the North Bristol NHS Trust Hospital, Bristol, UK, in patients with Parkinson's disease recruited from community and hospital settings in the UK. We included patients who had fallen at least once in the year before enrolment, were able to walk 18 m without an aid, had no previous exposure to an acetylcholinesterase inhibitor, and did not have dementia. Our clinical trials unit randomly assigned (1:1) patients to oral rivastigmine or placebo capsules (both taken twice a day) using a computer-generated randomisation sequence and web-based allocation. Rivastigmine was uptitrated from 3 mg per day to the target dose of 12 mg per day over 12 weeks. Both the trial team and patients were masked to treatment allocation. Masking was achieved with matched placebo capsules and a dummy uptitration schedule. The primary endpoint was difference in step time variability between the two groups at 32 weeks, adjusted for baseline age, cognition, step time variability, and number of falls in the previous year. We measured step time variability with a triaxial accelerometer during an 18 m walking task in three conditions: normal walking, simple dual task with phonemic verbal fluency (walking while naming words beginning with a single letter), and complex dual task switching with phonemic verbal fluency (walking while naming words, alternating between two letters of the alphabet). Analysis was by modified intention to treat; we excluded from the primary analysis patients who withdrew, died, or did not attend the 32 week assessment. This trial is registered with ISRCTN, number 19880883. Between Oct 4, 2012 and March 28, 2013, we enrolled 130 patients and randomly assigned 65 to the rivastigmine group and 65 to the placebo group. At week 32, compared with patients assigned to placebo (59 assessed), those assigned to rivastigmine (55 assessed) had improved step time variability for normal walking (ratio of geometric means 0·72, 95% CI 0·58–0·88; p=0·002) and the simple dual task (0·79; 0·62–0·99; p=0·045). Improvements in step time variability for the complex dual task did not differ between groups (0·81, 0·60–1·09; p=0·17). Gastrointestinal side-effects were more common in the rivastigmine group than in the placebo group (p<0·0001); 20 (31%) patients in the rivastigmine group versus three (5%) in the placebo group had nausea and 15 (17%) versus three (5%) had vomiting. Rivastigmine can improve gait stability and might reduce the frequency of falls. A phase 3 study is needed to confirm these findings and show cost-effectiveness of rivastigmine treatment. Parkinson's UK.

Background Robots offer an alternative, potentially advantageous method of providing repetitive, high-dosage, and high-intensity training to address the gait impairments caused by stroke. In this study, we compared the effects of the Stride Management Assist (SMA®) System, a new wearable robotic device developed by Honda R&D Corporation, Japan, with functional task specific training (FTST) on spatiotemporal gait parameters in stroke survivors. Methods A single blinded randomized control trial was performed to assess the effect of FTST and task-specific walking training with the SMA® device on spatiotemporal gait parameters. Participants ( n  = 50) were randomly assigned to FTST or SMA. Subjects in both groups received training 3 times per week for 6–8 weeks for a maximum of 18 training sessions. The GAITRite® system was used to collect data on subjects’ spatiotemporal gait characteristics before training (baseline), at mid-training, post-training, and at a 3-month follow-up. Results After training, significant improvements in gait parameters were observed in both training groups compared to baseline, including an increase in velocity and cadence, a decrease in swing time on the impaired side, a decrease in double support time, an increase in stride length on impaired and non-impaired sides, and an increase in step length on impaired and non-impaired sides. No significant differences were observed between training groups; except for SMA group, step length on the impaired side increased significantly during self-selected walking speed trials and spatial asymmetry decreased significantly during fast-velocity walking trials. Conclusions SMA and FTST interventions provided similar, significant improvements in spatiotemporal gait parameters; however, the SMA group showed additional improvements across more parameters at various time points. These results indicate that the SMA® device could be a useful therapeutic tool to improve spatiotemporal parameters and contribute to improved functional mobility in stroke survivors. Further research is needed to determine the feasibility of using this device in a home setting vs a clinic setting, and whether such home use provides continued benefits. Trial registration This study is registered under the title “Development of walk assist device to improve community ambulation” and can be located in clinicaltrials.gov with the study identifier: NCT01994395 .

Background Many studies have demonstrated the usefulness of repetitive task practice by using robotic-assisted gait training (RAGT) devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. The aim of our pilot randomized clinical trial was to understand the neurophysiological basis of motor function recovery induced by the association between RAGT (by using Lokomat device) and VR (an animated avatar in a 2D VR) by studying electroencephalographic (EEG) oscillations. Methods Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT + VR), whereas the other group underwent Lokomat without VR (RAGT-VR). The outcomes (clinical, kinematic, and EEG) were measured before and after the robotic intervention. Results As compared to the RAGT-VR group, all the patients of the RAGT + VR group improved in the Rivermead Mobility Index and Tinetti Performance Oriented Mobility Assessment. Moreover, they showed stronger event-related spectral perturbations in the high-γ and β bands and larger fronto-central cortical activations in the affected hemisphere. Conclusions The robotic-based rehabilitation combined with VR in patients with chronic hemiparesis induced an improvement in gait and balance. EEG data suggest that the use of VR may entrain several brain areas (probably encompassing the mirror neuron system) involved in motor planning and learning, thus leading to an enhanced motor performance. Trial registration Retrospectively registered in Clinical Trials on 21-11-2016, n. NCT02971371 .

Background Impaired balance and gait in stroke survivors are associated with decreased functional independence. This study aimed to evaluate the effectiveness of unilateral lower-limb exoskeleton robot-assisted overground gait training compared with conventional treatment and to explore the relationship between neuroplastic changes and motor function recovery in subacute stroke patients. Methods In this randomized, single-blind clinical trial, 40 patients with subacute stroke were recruited and randomly assigned to either a robot-assisted training (RT) group or a conventional training (CT) group. All outcome measures were assessed at the enrollment baseline (T0), 2nd week (T1) and 4th week (T2) of the treatment. The primary outcome was the between-group difference in the change in the Berg balance scale (BBS) score from baseline to T2. The secondary measures included longitudinal changes in the Fugl-Meyer assessment of the lower limb (FMA-LE), modified Barthel index (mBI), functional ambulation category (FAC), and locomotion assessment with gait analysis. In addition, the cortical activation pattern related to robot-assisted training was measured before and after intervention via functional near-infrared spectroscopy. Results A total of 30 patients with complete data were included in this study. Clinical outcomes improved after 4 weeks of training in both groups, with significantly better BBS (F = 6.341, p  = 0.018, partial η2 = 0.185), FMA-LE (F = 5.979, p  = 0.021, partial η2 = 0.176), FAC (F = 7.692, p  = 0.010, partial η2 = 0.216), and mBI scores (F = 7.255, p  = 0.042, partial η2 = 0.140) in the RT group than in the CT group. Both groups showed significant improvement in gait speed and stride cadence on the locomotion assessment. Only the RT group presented a significantly increased stride length (F = 4.913, p  = 0.015, partial η2 = 0.267), support phase (F = 5.335, p  = 0.011, partial η2 = 0.283), and toe-off angle (F = 3.829, p  = 0.035, partial η2 = 0.228) on the affected side after the intervention. The RT group also showed increased neural activity response over the ipsilesional motor area and bilateral prefrontal cortex during robot-assisted weight-shift and gait training following 4 weeks of treatment. Conclusions Overground gait training with a unilateral exoskeleton robot showed improvements in balance and gait functions, resulting in better gait patterns and increased gait stability for stroke patients. The increased cortical response related to the ipsilesional motor areas and their related functional network is crucial in the rehabilitation of lower limb gait in post-stroke patients.

ObjectiveTo evaluate the long-term effect of 60 Hz stimulation of the subthalamic nucleus (STN) on dysphagia, freezing of gait (FOG) and other motor symptoms in patients with Parkinson’s disease (PD) who have FOG at the usual 130 Hz stimulation.MethodsThis is a prospective, sequence randomised, crossover, double-blind study. PD patients with medication refractory FOG at 130 Hz stimulation of the STN were randomised to the sequences of 130 Hz, 60 Hz or deep brain stimulation off to assess swallowing function (videofluoroscopic evaluation and swallowing questionnaire), FOG severity (stand–walk–sit test and FOG questionnaire) and motor function (Unified PD Rating Scale, Part III motor examination (UPDRS-III)) at initial visit (V1) and follow-up visit (V2, after being on 60 Hz stimulation for an average of 14.5 months), in their usual medications on state. The frequency of aspiration events, perceived swallowing difficulty and FOG severity at 60 Hz compared with 130 Hz stimulation at V2, and their corresponding changes at V2 compared with V1 at 60 Hz were set as primary outcomes, with similar comparisons in UPDRS-III and its subscores as secondary outcomes.ResultsAll 11 enrolled participants completed V1 and 10 completed V2. We found the benefits of 60 Hz stimulation compared with 130 Hz in reducing aspiration frequency, perceived swallowing difficulty, FOG severity, bradykinesia and overall axial and motor symptoms at V1 and persistent benefits on all of them except dysphagia at V2, with overall decreasing efficacy when comparing V2 to V1.ConclusionsThe 60 Hz stimulation, when compared with 130 Hz, has long-term benefits on reducing FOG, bradykinesia and overall axial and motor symptoms except dysphagia, although the overall benefits decrease with long-term use.Clinical trial registration NCT02549859; Pre-results.

Many people with chronic stroke (PwCS) exhibit deficits in step width modulation, an important strategy for walking balance. A single exposure to swing leg perturbations can temporarily strengthen this modulation. The objective of this parallel, double-blinded, randomized controlled trial was to investigate whether repeated perturbations cause sustained increases in step modulation (NCT02964039; funded by the VA). 54 PwCS at the Medical University of South Carolina were randomly assigned to one of three intervention groups: Control (n = 18), with minimal forces; Assistive (n = 18), pushing the swing leg toward a mechanically appropriate location; Perturbing (n = 18), pushing the swing leg away from a mechanically appropriate location. All intervention groups included 24 training sessions over 12-weeks with up to 30-minutes of treadmill walking while interfaced with a novel force-field and a 12-week follow-up period, with five interspersed assessment sessions. Our primary outcome measure was paretic step width modulation, the partial correlation between step width and pelvis displacement (ρ SW ). Secondarily, we quantified swing and stance leg contributions to step modulation, clinical assessments of walking balance and confidence, and real-world falls. Outcomes were analyzed for participants who completed all assessment sessions (n = 44). Only the Perturbing group exhibited significant increases in paretic ρ SW , which were present after 4-weeks of training and sustained through follow-up (t = 2.42–3.17). These changes were due to improved control of paretic swing leg positioning. However, perturbation-induced changes in step modulation were not always significantly greater than those in the Control group, and clinical assessments were similar across intervention groups. Participants in the Perturbing group experienced a lower fall rate than those in the Control group (incidence rate ratio = 0.53), although our small sample size warrants caution. The present results indicate that perturbations can cause sustained modifications of targeted biomechanical characteristics of post-stroke gait, although such changes alone may be insufficient to change more complex clinical assessments.

Background The loss of gait automaticity is a key cause of motor deficits in Parkinson’s disease (PD) patients, even at the early stage of the disease. Action observation training (AOT) shows promise in enhancing gait automaticity. However, effective assessment methods are lacking. We aimed to propose a novel gait normalcy index based on dual task cost (NIDTC) and evaluate its validity and responsiveness for early-stage PD rehabilitation. Methods Thirty early-stage PD patients were recruited and randomly assigned to the AOT or active control (CON) group. The proposed NIDTC during straight walking and turning tasks and clinical scale scores were measured before and after 12 weeks of rehabilitation. The correlations between the NIDTCs and clinical scores were analyzed with Pearson correlation coefficient analysis to evaluate the construct validity. The rehabilitative changes were assessed using repeated-measures ANOVA, while the responsiveness of NIDTC was further compared by t tests. Results The turning-based NIDTC was significantly correlated with multiple clinical scales. Significant group-time interactions were observed for the turning-based NIDTC (F = 4.669, p = 0.042), BBS (F = 6.050, p = 0.022) and PDQ-39 (F = 7.772, p = 0.011) tests. The turning-based NIDTC reflected different rehabilitation effects between the AOT and CON groups, with the largest effect size (p = 0.020, Cohen’s d = 0.933). Conclusion The turning-based NIDTC exhibited the highest responsiveness for identifying gait automaticity improvement by providing a comprehensive representation of motor ability during dual tasks. It has great potential as a valid measure for early-stage PD diagnosis and rehabilitation assessment. Trial registration Chinese Clinical Trial Registry: ChiCTR2300067657