scholarly journals Efficacy and safety of onabotulinumtoxinA with standardized physiotherapy for the treatment of pediatric lower limb spasticity: A randomized, placebo-controlled, phase III clinical trial

2021 ◽  
pp. 1-14
Author(s):  
Rozalina Dimitrova ◽  
Heakyung Kim ◽  
Jill Meilahn ◽  
Henry G. Chambers ◽  
Brad A. Racette ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Lower Limb ◽  
Controlled Trial ◽  
Phase Iii ◽  
Double Blind ◽  
Dynamic Component ◽  
Related Quality ◽  
Health Related ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

BACKGROUND: Spasticity is common in cerebral palsy and can result in pain and diminished health-related quality of life. OBJECTIVE: To evaluate the safety and efficacy of onabotulinumtoxinA for lower limb spasticity treatment in children with cerebral palsy. METHODS: In this registrational phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT01603628), children (2–<  17 years) with cerebral palsy and ankle spasticity (Modified Ashworth Scale-Bohannon [MAS] score≥2) were randomized 1 : 1:1 to standardized physical therapy and onabotulinumtoxinA (4 or 8 U/kg), or placebo. Primary endpoint was average change from baseline at weeks 4 and 6 in MAS ankle score. Secondary endpoints included the Modified Tardieu Scale (MTS) and Global Attainment Scale (GAS). RESULTS: 381 participants were randomized. MAS scores averaged at weeks 4 and 6 were significantly reduced with both onabotulinumtoxinA doses (8 U/kg: –1.06, p = 0.010; 4 U/kg: –1.01, p = 0.033) versus placebo (–0.8). Significant improvements in average dynamic component of spasticity, measured by MTS, and in function, measured by GAS, were observed at several time points with both onabotulinumtoxinA doses versus placebo. Most adverse events were mild or moderate. CONCLUSIONS: OnabotulinumtoxinA was well tolerated and effective in reducing lower limb spasticity and improving functional outcomes versus placebo in children.

scholarly journals Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial

2010 ◽  
Vol 257 (8) ◽  
pp. 1330-1337 ◽  
Author(s):  
Ryuji Kaji ◽  
Yuka Osako ◽  
Kazuaki Suyama ◽  
Toshio Maeda ◽  
Yasuyuki Uechi ◽  
...  
Keyword(s):  
Botulinum Toxin ◽  
Lower Limb ◽  
Controlled Trial ◽  
Botulinum Toxin Type A ◽  
Botulinum Toxin Type ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Stroke ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

scholarly journals Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053908
Author(s):  
Stéphanie Sigaut ◽  
Camille Couffignal ◽  
Marina Esposito-Farèse ◽  
Vincent Degos ◽  
Serge Molliex ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Lower Limb ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Functional Decline ◽  
Assessment Method ◽  
Phase Iii ◽  
Double Blind ◽  
Prolonged Length ◽  
Surgery In Elderly

IntroductionPostoperative delirium (POD) is one of the most frequent complication after surgery in elderly patients, and is associated with increased morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Perioperative inflammatory stress is a key element in POD genesis. Melatonin exhibits antioxidative and immune-modulatory proprieties that are promising concerning delirium prevention, but in perioperative context literature are scarce and conflicting. We hypothesise that perioperative melatonin can reduce the incidence of POD.Methods and analysisThe DELIRLESS trial is a prospective, national multicentric, phase III, superiority, comparative randomised (1:1) double-blind clinical trial. Among patients aged 70 or older, hospitalised and scheduled for surgery of a severe fracture of a lower limb, 718 will be randomly allocated to receive either melatonin 4 mg per os or placebo, every night from anaesthesiologist preoperative consultation and up to 5 days after surgery. The primary outcome is POD incidence measured by either the French validated translation of the Confusion Assessment Method (CAM) score for patients hospitalised in surgery, or CAM-ICU score for patients hospitalised in ICU (Intensive Care Unit). Daily delirium assessment will take place during 10 days after surgery, or until the end of hospital stay if it is shorter. POD cumulative incidence function will be compared at day 10 between the two randomised arms in a competing risks framework, using the Fine and Grey model with death as a competing risk of delirium.Ethics and disseminationThe DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP) Sud-Est (ref CPP2020-18-99 2019-003210-14) for all study centres. Participant recruitment begins in December 2020. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT04335968, first posted 7 April 2020.Protocol version identifierN°3–0, 3 May 2021.

scholarly journals The effectiveness of additional core stability exercises in improving dynamic sitting balance, standing balance, lower-limb spasticity, falls and gait in subacute stroke patients (CORE-trial). Study protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Rosa Cabanas-Valdés ◽  
Lidia Boix-Sala ◽  
Montserrat Grau-Pellicer ◽  
Juan Antonio Guzmán-Bernal ◽  
Fernanda Maria Caballero-Gómez ◽  
...  
Keyword(s):  
Lower Limb ◽  
Daily Living ◽  
Controlled Trial ◽  
Core Stability ◽  
Standing Balance ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Limb Spasticity ◽  
Lower Limb Spasticity ◽  
Dynamic Sitting

Abstract BackgroundTrunk impairment produces disorders of motor control, balance, and gait that are correlated with increased risk of falls and reduced mobility in stroke survivors. This creates disability and dependency to perform their activities of daily living. Alterations in body alignment occur, requiring treatment strategies focused on improving the postural control. bearing. Core stability exercises (CSE) are a good strategy to improve local strength of trunk, dynamic sitting, standing balance, and gait. There is some evidence about its effectiveness but it is still necessary to run a large multicenter trial to ratify that existing evidence.MethodsThis is a single-blind multicenter randomized controlled trial. Two parallel groups are compared and both perform the same type of therapy. A control group (CG) (n=110) performs conventional physiotherapy (CP) (1 hour per session) focused on improving balance. An experimental group (EG) (n=110) performs CSE (30 minutes) in addition to CP (30 minutes) (1 hour/session in total). EG is divided in two subgroups, in which only half of patients (n=55) perform CSE plus transcutaneous electrical nerve stimulation (TENS). Primary outcome measures are dynamic sitting, assessed by Spanish-version of Trunk Impairment Scale and stepping, assessed by Brunel Balance Assessment. Secondary outcomes are postural control, assessed by Postural Assessment Scale for Stroke patients; standing balance and risk of fall assessed by Berg Balance Scale; gait speed by BTS G-Walk (accelerometer); rate of falls, lower-limb spasticity by Modified Ashworth Scale; activities of daily living by Barthel Index; and quality of life by EQ-5D-5L. These are evaluated at baseline (T0), at 3 weeks (T1), at 5 weeks -at the end of the intervention (T2), at 17 weeks (T3) and at 29 weeks (T4). Study duration per patient is 29 weeks (a 5-week intervention, followed by a 24-week post-intervention). DiscussionThe study will provide useful information on the short and long term effects of a physiotherapy rehabilitation program based on core stability exercises performed in subacute phase.Trial registrationClinicalTrials.gov Identifier NCT03975985. Data registration June 5th, 2019. Retrospectively registered. Date of registration in primary registry: June 5, 2019. Protocol version 1

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