Dataset Information

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

ABSTRACT: Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ?1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ?1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.

SUBMITTER: Khan P

PROVIDER: S-EPMC7762077 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Khan Patricia P Riberto Marcelo M Frances João Amaury JA Chueire Regina R Amorim Ana Cristina Ferreira Garcia ACFG Xerez Denise D Chung Tae Mo TM Mercuri Lucia Helena Costa LHC Longo Alexandre Luiz AL Lianza Sérgio S Maisonobe Pascal P Ruiz-Schutz Viviane C VC

Toxins 20201204 12

Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients rece ...[more]

PMID: 33291807

Similar Datasets

Project description:BackgroundThe anti-spasticity efficacy of botulinum toxin (BoNT) injection has been well established for patients with chronic stroke; however, extracorporeal shock wave therapy (ESWT), i.e. focused shockwave (FSW) and radial shockwave (RSW), has recently been applied. We aimed to investigate the comparative effectiveness of BoNT vs. ESWT in the reduction of spasticity among stroke survivors.MethodsPubMed, EMBASE, MEDLINE and Cochrane CENTRAL were searched from the earliest record to September 2021 for randomized controlled trials. Weighted mean differences (WMDs) on the reduction of the Modified Ashworth Scale before or at the 6th post-treatment week (short-term) and between the 7th and 12th weeks (mid-term) after the intervention were calculated. Ranking probabilities of the WMD were simulated to determine which treatment had the potential to possess the best effectiveness. inplasy.com registration: INPLASY202170018.FindingsA total of 33 studies comprising 1,930 patients were enrolled. The network meta-analysis revealed that BoNT injections, FSW and RSW were better in spasticity reduction than the control treatment(s) at the short term, with WMDs of -0.69 (95% CI, -0.87 to -0.50), -0.36 (95% CI, -0.69 to -0.03) and -0.62 (95% CI, -0.84 to -0.40), respectively. Likewise, mid-term effects of BoNT injections, FSW and RSW also revealed superiority, with WMDs of -0.44 (95% CI, -0.62 to -0.26), -0.74 (95% CI, -1.26 to -0.23) and -0.79 (95% CI, -1.07 to -0.51), respectively. Ranking probability analysis revealed that RSW had the highest probability of being the best treatment for spasticity reduction at the short-term (62.2%) and mid-term (72.3%) periods during the follow up.InterpretationBoNT injections and ESWT are effective in alleviating post-stroke spasticity at the mid-term. The effectiveness of ESWT was comparable to BoNT injections, and RSW had the potential to be the best treatment for spasticity reduction among the three treatment options. More prospective trials incorporating head-to-head comparisons of BoNT injections vs. ESWT are needed to validate the role of ESWT in reducing post-stroke spasticity.FundingThe current research project was supported by (1) National Taiwan University Hospital, Bei-Hu Branch; (2) Ministry of Science and Technology (MOST 106-2314-B-002-180-MY3 and 109-2314-B-002-114-MY3); 3) Taiwan Society of Ultrasound in Medicine.

Project description:ObjectiveTo test the feasibility and efficacy of the VibroTactile Stimulation (VTS) Glove, a wearable device that provides VTS to the impaired limb to reduce spastic hypertonia.DesignProspective 2-arm intervention study-including 1 group of patients who use Botulinum toxin (BTX-A) for spasticity and 1 group of patients who do not use BTX-A.SettingParticipants were recruited through rehabilitation and neurology clinics.ParticipantsPatients with chronic stroke (N=20; mean age=54 years, mean time since stroke=6.9 years). Patients who were previously receiving the standard of care (BTX-A injection) were eligible to participate and started the intervention 12 weeks after their last injection.InterventionParticipants were instructed to use the VTS Glove for 3 hours daily, at home or during everyday activities, for 8 weeks.Main outcome measuresSpasticity was assessed with the Modified Ashworth Scale and the Modified Tardieu Scale at baseline and then at 2-week intervals for 12 weeks. Primary outcomes were the difference from baseline and at week 8 (end of VTS Glove use) and week 12 (4 weeks after stopping VTS Glove use). Patients who were receiving BTX-A were also assessed during the 12 weeks preceding the start of VTS Glove use to monitor the effect of BTX-A on spastic hypertonia. Range of motion and participant feedback were also studied.ResultsA clinically meaningful difference in spastic hypertonia was found during and after daily VTS Glove use. Modified Ashworth and Modified Tardieu scores were reduced by an average of 0.9 (P=.0014) and 0.7 (P=.0003), respectively, at week 8 of daily VTS Glove use, and by 1.1 (P=.00025) and 0.9 (P=.0001), respectively, 1 month after stopping VTS Glove use. For participants who used BTX-A, 6 out of 11 showed greater change in Modified Ashworth ratings during VTS Glove use (mean=-1.8 vs mean=-1.6 with BTX-A) and 8 out of 11 showed their lowest level of symptoms during VTS Glove use (vs BTX-A).ConclusionsDaily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of the participants who had regularly used BTX-A, the VTS Glove provided equal or greater symptom relief.

Dataset Information

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Publications

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets