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Background Post-stroke spasticity (PSS) in the ankle plantar flexors leads to abnormal gait, increased energy expenditure, and a higher risk of falls. Ultrasonographic measures, such as muscle fascicle length (MFL) and pennation angle (PA), provide insight into muscle changes associated with spasticity. This study aimed to investigate the dose-dependent effects of focused extracorporeal shockwave therapy (ESWT) on ultrasonographic muscle properties and clinical outcomes in patients with PSS of the ankle plantar flexors. Methods This post hoc analysis was based on a double-blind, randomized controlled trial investigating different ESWT doses for post-stroke ankle spasticity treatment. A total of 39 patients with PSS of the ankle plantar flexors were randomized into two groups: the double-dose ESWT group received 4,000 focused shockwave pulses per session, while the control ESWT group received 2,000 pulses per session. Both groups received four ESWT sessions over a two-week intervention period, followed by a 24-week follow-up period for outcome assessments. Outcome measures included ultrasonographic assessments of MFL, PA, and strain elastography, as well as clinical evaluations using the Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS), passive range of motion (PROM), Timed Up and Go (TUG) test, and Barthel Index at baseline, and at 1, 4, 12, and 24 weeks post-treatment. Results No significant within-group changes in PA or MFL were observed for either ESWT group over the 24-week period. Generalized estimation equation analysis showed no significant group effects on PA, MFL, or strain elastography. However, when analyzing all participants, a significant time-related improvement in MFL was identified. In the double-dose ESWT group, MFL was significantly correlated with MTS, PROM, and TUG test, while PA was significantly correlated with MAS. Given that this was a post hoc analysis, these results should be interpreted conservatively. Conclusions While PA and MFL did not show significant differences between groups, the double-dose ESWT group exhibited improved clinical outcomes linked to MFL. These findings suggest that increased ESWT dosage may enhance muscle architecture and function in stroke rehabilitation.

Grafting of C7 from the nonparalyzed to the paralyzed side in patients with arm paralysis resulted in greater improvements in power, spasticity, and function at 12 months than rehabilitation therapy alone, and functional connection to the ipsilateral cerebral hemisphere developed.

Stroke is the principal cause of permanent disability in adult age, and many patients require lifelong medical treatment and care from others for their daily activities. It has enormous repercussions on the work and social lives of patients and their families and involves major economic expenditure. Post-stroke spastic upper limb is usually treated with rehabilitation, occupational therapy, and periodical injections of botulinum toxin, while surgical correction is now seldom considered. However, there has been no clinical trial to compare between surgical and toxin treatments. The primary aim of this study is to compare outcomes between surgery and a conventional approach with botulinum toxin in patients with post-stroke upper limb spasticity. A two-arm (surgical treatment [n = 22] vs. botulinum toxin [n = 22]) randomized clinical trial (RCT) will be performed to compare the efficacy of surgery with that of botulinum toxin treatment in patients with post-stroke upper limb spasticity. Data will be collected at baseline and at 6 and 12 months of follow-up on functionality, hygienic status, quality of life, sleep quality, anxiety/depression levels, and functional magnetic resonance imaging (fMRI)-measured brain activity. Healthcare and care costs will be compared between the groups. This research is set in the context of chronic diseases, aging, and functional/mobility limitations. The results can be expected to have a major impact, because the high prevalence of stroke and the severe associated disability means that an enormous number of patients can benefit from improved treatment protocols, and a more rational use of resources would yield considerable economic benefits for health and care systems. Our expectation is that outcomes would be more favorable with surgery. However, the aim is not to exclude any approach but rather to explore how the potential and indications of each treatment could be integrated within a multidisciplinary therapeutic protocol in a complementary manner. Trial Registration: ClinicalTrials.gov (NCT06392633). Registered on 30 April 2024.

To investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for managing upper limb muscular spasticity after stroke, and to examine its therapeutic effects on spasticity and motor function in the upper limb. A total of 110 post-stroke patients with upper limb spasticity were randomly assigned to the experimental or the control group. The experimental group received rTMS in conjunction with conventional rehabilitation therapy. The affected side of the head received daily treatment for 20 min each at Erb’s point and the stimulation point, totaling 15 sessions over six days per week. The stimulation frequencies were 10 Hz (high frequency, M1 region) and 1 Hz (low frequency, Erb’s point), with an intensity at 120% of the threshold. The control group received sham stimulation alongside conventional rehabilitation therapy. Assessments including the Modified Ashworth Scale (MAS) and Fugl-Meyer Assessment for Upper Extremity (FM-UE), were also conducted before treatment initiation and after 15 rounds of rTMS. Post hoc subgroup analyses were conducted using independent-sample t -tests for FM-UE scores and Mann-Whitney U tests for MAS scores to assess heterogeneity in treatment responses by stroke type (cerebral infarction vs. intracerebral hemorrhage). Among these 110 patients, 25 patients were excluded from the study for various reasons. Hence, 53 patients were included in the control group and 32 patients were included in the experimental group. Following 15 rounds of rTMS, the experimental group exhibited a reductions in MAS score ( P  = 0.004). FM-UE scores increased significantly in both groups (both P  < 0.05), with significant improvement observed in the experimental group ( P  < 0.05). Subgroup analyses revealed no significant differences in FM-UE or MAS outcomes between stroke types, likely due to the limited sample size of intracerebral hemorrhage participants (experimental group: n  = 8; control group: n  = 16). rTMS effectively alleviates upper limb spasticity and enhances motor function after stroke by modulating cortical and spinal nerve excitability.

Mechanical digit sensory stimulation (MDSS), applied once solely to paralyzed fingers in stroke patients, has been clinically shown to immediately and significantly reduce muscle spasticity in the affected hand, enabling active finger extension. This study investigated the effects of one course of MDSS on upper limb motor function in stroke patients with hemiplegia. Forty patients were randomly assigned to either a Control group, receiving only conventional rehabilitation, or an MDSS group, receiving both conventional rehabilitation and MDSS for 2–4 weeks. Before and after the intervention, measurements were taken, including muscle tone, surface electromyographic signals (sEMG), motor function, and activities of daily living. The results revealed that while both groups showed improvements, the MDSS group exhibited significantly lower muscle tone scores, larger sEMG for specific muscle groups, and higher motor function scores compared to the Control group. Although the MDSS group demonstrated greater improvements in activities of daily living, these differences were not statistically significant. In conclusion, MDSS effectively alleviates muscle spasticity and aids in enhancing muscle strength and motor function in stroke patients with hemiplegia. •MDSS + rehab improved upper limb motor function in stroke patients vs. rehab alone.•MDSS reduced spasticity in finger/elbow flexors, boosted extensor strength (p<0.05).•MDSS showed safety, high acceptance, mild pain (VAS<6), no serious adverse events.•sEMG RMS quantified muscle changes, showing significant extensor strength gains.

Background This study aimed to evaluate the combined effects of robotic training (RT) and botulinum toxin (BTX) injections on motor function and spasticity in individuals with post-stroke upper limb spasticity (ULS). We also sought to investigate the optimal timing of RT and BTX administration. Methods Forty-two participants with chronic stroke-induced ULS were initially enrolled and randomized into four groups: Group B4R4 (RT + BTX at 4 weeks [W4]), Group B0R0 (RT + BTX at baseline [W0]), Group B0R4 (BTX at W0, RT at W4), and Group B4R0 (RT at W0, BTX at W4). Clinical assessments and robotic kinematic evaluations were performed at W0, W4, and 8 weeks (W8). The primary outcome was the Fugl-Meyer assessment (FMA) score, and secondary outcomes included the modified Ashworth scale (MAS) of the elbow and kinematic parameters, such as spectral arc length, mean speed, hand path ratio, and movement deviation in various tasks. Changes in outcome measures over time were analyzed using a linear mixed-effects regression model or ordinal logistic regression. Results Of the 42 participants, 40 completed the study. From W0 to W4, Group B0R0 exhibited the most favorable outcomes in terms of spasticity (MAS-elbow flexor and extensor) and kinematic variables, suggesting that the combined application of BTX and RT is superior to sole interventions in improving motor function and spasticity. From W0 to W8, Group B0R4 demonstrated the most substantial improvements in FMA scores and kinematic parameters, indicating that the combined use of BTX and RT, particularly when RT is initiated 1 month after BTX injection, results in superior functional outcomes compared to other intervention timings. Conclusions The combination of RT and BTX is more effective in enhancing motor function and reducing spasticity in individuals with ULS than either intervention alone or no intervention. Furthermore, the timing of RT relative to BTX injection plays a critical role in maximizing therapeutic benefits in individuals with stroke and ULS, given the distinct modes of action of each intervention. Trial registration clinicaltrials.gov NCT02228863. The study was retrospectively registered on August 23, 2014.

Spasticity is a persistent and debilitating consequence of stroke and effective rehabilitation is a healthcare priority. Botulinum neurotoxin A (BoNT-A) with supportive therapy has increasingly been embedded within clinical practice for treatment of post-stroke spasticity. But the evidence for this approach has hitherto been limited to the findings of a limited number of small trials. The InTENSE trial was undertaken specifically to provide high-quality clinical trial evidence focusing on the effect of BoNT-A and adjunctive therapy on upper limb spasticity. While the clinical trial did not detect a significant impact upon clinical outcomes, there remains a need to evaluate any impact on the broader use of healthcare resources and overall cost-effectiveness. A detailed cost–utility analysis of the InTENSE trial was undertaken. The costs over the 12-month follow-up period were compared with quality-adjusted life years (QALY) gained using utilities generated from the EQ-5D three level (EQ-5D-3L) instrument. There were no significant differences in QALY gained between the intervention and control groups identified, or in the majority of health and community care costs. The Incremental Cost-Effectiveness Ratio per QALY gained was estimated at AU $63,947.11 (Australian dollars), which is well above accepted thresholds for cost-effectiveness in Australia. The study was unable to identify evidence for the cost-effectiveness of treatment approaches combining BoNT-A with adjunctive therapy.

Even though robotic rehabilitation is very useful to improve motor function, there is no conclusive evidence on its role in reducing post-stroke spasticity. Focal muscle vibration (MV) is instead very useful to reduce segmental spasticity, with a consequent positive effect on motor function. Therefore, it could be possible to strengthen the effects of robotic rehabilitation by coupling MV. To this end, we designed a pilot randomized controlled trial (Clinical Trial NCT03110718) that included twenty patients suffering from unilateral post-stroke upper limb spasticity. Patients underwent 40 daily sessions of Armeo-Power training (1 hour/session, 5 sessions/week, for 8 weeks) with or without spastic antagonist MV. They were randomized into two groups of 10 individuals, which received (group-A) or not (group-B) MV. The intensity of MV, represented by the peak acceleration (a-peak), was calculated by the formula (2πf)2A, where f is the frequency of MV and A is the amplitude. Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio (HMR) were the primary outcomes measured before and after (immediately and 4 weeks later) the end of the treatment. In all patients of group-A, we observed a greater reduction of MAS (p = 0.007, d = 0.6) and HMR (p<0.001, d = 0.7), and a more evident increase of SICI (p<0.001, d = 0.7) up to 4 weeks after the end of the treatment, as compared to group-B. Likewise, group-A showed a greater function outcome of upper limb (Functional Independence Measure p = 0.1, d = 0.7; Fugl-Meyer Assessment of the Upper Extremity p = 0.007, d = 0.4) up to 4 weeks after the end of the treatment. A significant correlation was found between the degree of MAS reduction and SICI increase in the agonist spastic muscles (p = 0.004). Our data show that this combined rehabilitative approach could be a promising option in improving upper limb spasticity and motor function. We could hypothesize that the greater rehabilitative outcome improvement may depend on a reshape of corticospinal plasticity induced by a sort of associative plasticity between Armeo-Power and MV.

This randomized controlled clinical trial investigated the effects of gastrocnemius functional massage (GFM) combined with neurodevelopmental treatment (NDT) on spasticity, gait parameters, and functional mobility in stroke patients. A total of 28 chronic stroke survivors were randomized into an experimental group (EG, n = 13) and a control group (CG, n = 15). Both groups received NDT twice a week for six weeks, while the EG received additional GFM. Spasticity (Modified Ashworth Scale), gait parameters (LegSys), and functional mobility (Timed Up and Go test) were assessed pre- and post-treatment. The results showed significant improvements in spasticity within the EG for the hip adductor (p = 0.002), knee extensor (p = 0.006), and ankle plantar flexor muscles (p = 0.002), compared to minimal changes in the CG (p > 0.05). Gait analysis revealed significant improvements in the EG for stride number (p = 0.0001), stride length (p = 0.006), stride time (p = 0.001), and stride velocity (p = 0.002), whereas the CG showed no significant changes (p > 0.05). Functional mobility improvements in the EG included reduced sit-to-stand time (p = 0.021) and total Timed Up and Go time (p = 0.001), indicating enhanced dynamic balance and lower extremity strength. These findings suggest that combining GFM with NDT significantly enhances spasticity reduction, gait parameters, and functional mobility in stroke patients. Future studies are needed to explore the long-term effects and underlying mechanisms of this combined approach. This study was registered at www.clinicaltrials.gov under the identification number NCT06265753.

Spasticity is a major determinant of disability and decline in quality of life in patients with motor neuron disease. Cannabinoids have been approved for symptomatic treatment of spasticity in multiple sclerosis. We investigated whether cannabinoids might also reduce spasticity in patients with motor neuron disease. We did an investigator-initiated, randomised, double-blind, placebo-controlled, phase 2 clinical trial at four tertiary motor neuron disease centres in Italy. Eligible patients were aged 18–80 years; had possible, laboratory-supported probable, probable, or definite amyotrophic lateral sclerosis as defined by revised El Escorial criteria, or primary lateral sclerosis according to Pringle's criteria; had spasticity symptoms due to motor neuron disease for at least 3 months; had spasticity scores of 1 or greater in at least two muscle groups on the Modified Ashworth Scale; and were taking an antispasticity regimen that was maintained at a stable dose for 30 days before enrolment. Participants were assigned (1:1) by an independent statistician via a computer-generated randomisation sequence to a standardised oromucosal spray (nabiximols) containing a defined combination of delta-9-tetrahydrocannabinol and cannabidiol (each 100 μL actuation contained 2·7 mg delta-9-tetrahydrocannabinol and 2·5 mg cannabidiol) or to placebo for 6 weeks. Participants self-titrated during the first 14 treatment days according to a predefined escalation scheme (maximum 12 actuations per 24 h), then maintained that dose for 4 weeks. The primary endpoint was the change in the score on the Modified Ashworth Scale, which was assessed at baseline and after 6 weeks. Safety and tolerability were also monitored. Participants, investigators, site personnel, and the study statistician were masked to treatment allocation. All randomised participants who received at least one dose of study drug were included in the analysis. This trial is registered with ClinicalTrials.gov, number NCT01776970. The trial is closed to new participants with follow-up completed. Between Jan 19, 2013, and Dec 15, 2014, 60 participants were randomly assigned, and 59 participants were included in the final analysis (29 in the nabiximols group and 30 in the placebo group). Modified Ashworth Scale scores improved by a mean of 0·11 (SD 0·48) in the nabiximols group and deteriorated by a mean of 0·16 (0·47) in the placebo group (adjusted effect estimate −0·32 [95% CI −0·57 to −0·069]; p=0·013). Nabiximols was well tolerated, and no participants withdrew from the double-blind phase of the study. No serious adverse effects occurred. In this proof-of-concept trial, nabiximols had a positive effect on spasticity symptoms in patients with motor neuron disease and had an acceptable safety and tolerability profile. These findings should be investigated further in larger clinical trials. Italian Research Foundation for Amyotrophic Lateral Sclerosis.