Introduction and objective: Up to 40% of stroke survivors will develop spasticity that may affect their ability to walk or cause other issues such as pain. The aim of this observational study was to assess longitudinal goal attainment with repeated injections of abobotulinumtoxinA (aboBoNT-A) for the management of leg spasticity in a routine clinical setting. Methods: AboliSh was a 16-month observational study (NCT04050527) that followed ambulatory adults (≥18 years able to take ≥5 steps with/without assistance) with unilateral leg spasticity who were treated with aboBoNT-A according to local clinical guidelines to achieve personalized treatment goals. Post-hoc analyses of cumulative goal attainment (assessed using GAS-leg across all treatment cycles) were performed for stroke survivors who underwent ≥1 BoNT-A injection cycle and had ≥1 GAS assessment (n=328). Potential predictors of response during Cycle 1 (defined as achieving a GAS T score of ≥50 during Cycle 1) were analyzed using a stepwise multivariate logistic regression model. We subsequently performed subgroup analyses for cumulated GAS T scores, categorized by age. Results: At Cycle 1, the median total injected dose of aboBoNT-A for the lower limb was 600U [range 100-1500U], which was injected into a median of 4 muscles [1-8]. Overall, 64% of study participants also required injections for upper limb spasticity; in these cases the median total body dose was 1362.5 U. At the population level, goals were achieved as expected over repeated cycles. The mean [95% CI] cumulated GAS-leg T score at 16 months was 48.2 [47.5, 49.0] (median of 50). Change in cumulated GAS T scores were clinically relevant; the mean change in GAS-leg score was 9.9 [9.1, 10.7] (median of 10). While age was found to be a significant prognostic factor in GAS-T response in Cycle 1 (p=0.03); mean±SD [median] cumulated GAS T scores were similar in the age subgroups of <50y: 49.4±7.1 [50] (n=103); 50-60y: 47.7±7.5 [50] (n=96); and >60y: 47.7±6.8 [50] (n=129). Conclusions: Results from this prospective, longitudinal study demonstrate the sustained functional benefit of repeated cycles of aboBoNT-A, as assessed by person-centered goal attainment.

Robot-assisted therapy (RAT) represents an evolving approach to post-stroke upper limb rehabilitation; however, its impact on spasticity modification remains inadequately characterized. Critical knowledge gaps persist due to the diversity of robotic technologies, heterogeneous treatment protocols, and methodological limitations in outcome reporting, particularly the conflation of proximal and distal spasticity measures. This systematic review and meta-analysis evaluated the comparative effectiveness of robotic versus conventional interventions for upper limb spasticity management, examining the influence of robotic design, stroke stage, and treatment dosage on spasticity outcomes. We searched six databases and two trial registries up to November 2024 for RCTs of RAT versus non-robotic comparators in adults with post-stroke upper limb spasticity. Secondary outcomes included upper-limb motor function, activities of daily living, and health-related quality of life. We used random (I2 ≥ 50

Background/Objectives: Choosing the best prosthetic foot for a patient is complicated by the many available options and limited evidence to distinguish them. This work aimed to clarify performance differences in the level-ground walking of K3-functional-level persons with amputations across a variety of prosthetic feet within the energy storage and return class. Methods: This clinical trial assessed 10 subjects fitted with the Ossur ProFlex foot (LP and XC) compared to their original foot after a 30-day adaptation period and careful prosthetic alignment matching. Multivariate data (walking performance, noise/play, balance and satisfaction) were collected in the gait laboratory. Results: Results were mixed across the cohort. MCID and statistical analysis were used to assess the magnitude and importance of the changes observed. Overall, the changes were small and not statistically significant. Conclusions: Our findings support that performance across a variety of measures for K3-level amputees walking over level ground is relatively insensitive to prosthetic foot componentry within the energy storage and return class. While functional performance is not the only metric that contributes to foot choice, it is an important one. This study helps to circumscribe its role in the larger decision-making framework for this class of componentry in persons with transtibial amputation.

BACKGROUND:Poststroke flexed elbow deformity is a frequent and disabling abnormal joint posture that impairs function, hygiene, and quality of life. Despite its clinical impact, assessment strategies and treatment sequencing remain heterogeneous, fragmented across disciplines, and poorly standardized. OBJECTIVES:To establish an international, interdisciplinary expert consensus on the assessment and management of poststroke flexed elbow deformity using a hypothesis-driven Delphi methodology. METHODS:An international Delphi process was conducted involving 28 experts in physical and rehabilitation medicine, orthopedic surgery, and neurosurgery from 12 countries. Three sequential, anonymous rounds of structured online questionnaires were administered. Statements addressed diagnosis, clinical and instrumental assessment, treatment selection, and surgical indications. Experts rated their agreement with each statement. Consensus was predefined as ≥80% agreement among respondents for a given item. RESULTS:Across 3 Delphi rounds, 164 statements were evaluated, of which 61 (38%) reached consensus. Experts, including physical and rehabilitation medicine physicians (n = 13), orthopedic surgeons (n = 10), and neurosurgeons (n = 1) agreed that functional impact assessment must precede treatment decisions and that differentiation between muscle overactivity and soft-tissue contracture is essential. Diagnostic motor nerve blocks and radiological imaging were endorsed as complementary tools in selected cases. Botulinum toxin injections combined with rehabilitation were supported as first-line treatment for correctable deformities, whereas surgical intervention was considered appropriate for partially or non-correctable deformities. Preoperative interdisciplinary consultation and formal goal setting were deemed mandatory before intervention. CONCLUSIONS:This Delphi-based international consensus provides structured, interdisciplinary guidance for the evaluation and management of poststroke flexed elbow deformity. By clarifying assessment principles, treatment sequencing, and indications for referral and surgery, this consensus aims to standardize care pathways and improve patient-centered outcomes. REGISTRATION:Not applicable. This study used a Delphi methodology involving expert opinion only, without human participant intervention.

Lack of head-to-head comparative safety and efficacy data for abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) represented an important gap for informed spasticity management. This study compared the safety and efficacy of aboBoNT-A and onaBoNT-A for upper limb spasticity (ULS). DIRECTION (NCT04936542), a phase IV, randomized, double-blind, crossover study, involved 72 sites. Patients stratified by botulinum toxin A status (naïve/non-naïve) were randomized (1:1) to aboBoNT-A 900U followed by onaBoNT-A 360U (one cycle each), or vice versa. Muscles (wrist/finger flexors, biceps brachii) were injected with a fixed volume, using instrument-guided injection techniques. Participants fulfilling retreatment criteria received a second cycle at Week 12; otherwise, they were reassessed every 4 weeks (to Week 24) until requiring retreatment. Primary analyses tested non-inferiority based on treatment-emergent adverse events (TEAEs) from injection to Week 12 using a 5 Spasticity of the upper limb presents as muscle and limb stiffness that affects the arm and/or hand. It happens when parts of the brain or spinal cord that control movement are damaged. Spasticity can be painful and can make daily activities challenging. Some people with upper limb spasticity receive botulinum toxin A (BoNT-A) injections to help relax the affected muscles. BoNT-A injections work for a period, but retreatment is required when the effects start to wear off. AbobotulinumtoxinA and onabotulinumtoxinA are different types of BoNT-A. DIRECTION is the first-ever spasticity study to compare abobotulinumtoxinA and onabotulinumtoxinA directly in people with upper limb spasticity. It involved 464 people living with spasticity across the USA, France, and Canada. The study population had an average age of 57 years, two-thirds were male, and most had spasticity because of a stroke. The study found that, over the 12 weeks after BoNT-A treatment, similar numbers of patients had side-effects to abobotulinumtoxinA and onabotulinumtoxinA. In addition, it took longer for symptoms to return after treatment with abobotulinumtoxinA (99 days) compared with onabotulinumtoxinA (96 days). Longer BoNT-A treatment duration can reduce the number of days that people with upper limb spasticity have to live with symptoms before their next injection. More symptom-free days could reduce the need for patients and their caregivers to seek additional care and could reduce their overall treatment burden. These findings provide new information to help healthcare professionals make decisions about BoNT-A treatment to achieve the best outcomes for their patients with arm/hand spasticity.

Objective:To evaluate the effect of repeat abobotulinumtoxinA treatment on quality of life (QOL) in patients with leg spasticity. Design:Secondary analysis of the prospective, longitudinal (16mo), observational AboLiSh study. Setting:Specialist neurorehabilitation centers across 9 countries. Participants:Ambulatory adults (66.4% men, mean age 53.9y) with unilateral lower limb spasticity able to take ≥5 steps with or without assistance. Interventions:Patients were treated with abobotulinumtoxinA (up to 6 cycles) per local guidelines to achieve individualized treatment goals. Main Outcome Measures:QOL was assessed at the start of each cycle using the symptom-specific Leg Activity measure (LegA; Parts A: passive function, B: active function, C: QOL impact) and the generic EQ-5D-5L scale. Results:At the population level, QOL improved on both scales across the first 4 treatment cycles. LegA Part C scores decreased and EQ-5D-5L index values increased with repeat treatment. LegA Part C scores showed moderate-to-strong inverse correlations with EQ-5D-5L index values at each cycle (Pearson's R: Cycle 1: -0.66; Cycle 2: -0.57; Cycle 3: -0.60; Cycle 4: -0.59; all P<.0001). LegA Part A scores were moderately-to-strongly correlated with EQ-5D-5L self-care domain scores across cycles 1-3 (Pearson's R: Cycle 1: 0.60; Cycle 2: 0.58; Cycle 3: 0.50; Cycle 4: 0.34; all P<.0001). LegA Part B scores were moderately-to-strongly correlated with EQ-5D-5L mobility domain scores across all cycles (Pearson's R: Cycle 1, 0.58; Cycle 2, 0.57; Cycle 3, 0.57; Cycle 4, 0.59; all P<.0001). Conclusions:Repeat lower limb treatment with abobotulinumtoxinA improved QOL as assessed by both symptom-specific and generic instruments. The significant correlations between LegA Part C and EQ-5D-5L support validity of the LegA to assess the impact of treatment on QOL in patients with leg spasticity.

Inconsistent and variably interpreted definitions of spasticity, alongside evolving mechanistic understanding, highlight the need for a clear, clinically relevant consensus definition. An international expert panel used a modified Delphi process to develop a concise, clinically applicable definition that reflects current understanding and supports consistent assessment and management. Participants reviewed existing definitions, completed a pre‑meeting survey, and engaged in structured discussions, with draft definitions iteratively refined through successive rounds of voting to achieve consensus. Key components identified included disordered sensorimotor control, central nervous system involvement, and velocity‑ and length‑dependent resistance to passive stretch, while existing definitions were considered either overly narrow or insufficiently relevant to clinical practice. The consensus definition characterizes spasticity as "A disorder of sensorimotor control resulting from upper motor neuron disease. It is characterized by velocity- and length-dependent involuntary muscle overactivity, which is intermittent or sustained, during passive stretch." This definition integrates contemporary mechanistic concepts with clinical applicability and is intended to improve conceptual clarity, facilitate communication, and promote consistency in diagnosis, measurement, and treatment.

Abstract Background and aims Up to 40% of stroke survivors will develop spasticity which may affect mobility and cause pain. We evaluated longitudinal goal attainment with repeated abobotulinumtoxinA (aboBoNT-A) injections for leg spasticity management in routine clinical practice. Methods AboLiSh was a 16-month observational study (NCT04050527) of ambulatory adults (≥18y, able to take ≥5 steps) with unilateral leg spasticity treated with aboBoNT-A per local guidelines to achieve personalised goals. Post-hoc analyses assessed cumulative goal attainment (GAS-leg) across cycles in stroke survivors with ≥1 injection and ≥1 GAS-leg assessment (n=328). Results At Cycle 1, the most popular primary goals were related to locomotion (39.6%) followed by pain/discomfort (18.6%). At Cycle 1, the median aboBoNT-A dose for the leg was 600U [range 100-1500U]. Muscle selection was consistent with foot equinus and/or varus; the most commonly injected muscles were the gastrocnemius (medial head 84%; lateral head 74%), soleus (67%), tibialis posterior (52%), flexor digitorum longus (41%), and flexor hallucis longus (22%). 64% of participants also required injections for arm spasticity; in these cases the median total body dose increased to 1362.5U. Goals were generally achieved as expected over repeated cycles. The mean [95%CI] cumulated GAS-leg T score at 16 months was 48.2 [47.5, 49.0] (median: 50). Change in cumulated GAS T scores were clinically relevant; the mean change in GAS-leg score was 9.9 [9.1, 10.7] (median: 10). Conclusions Results from this prospective, longitudinal real-world study demonstrate the sustained functional benefit of repeated cycles of aboBoNT-A for leg spasticity, as assessed by person-centered goal attainment. Conflict of interest Richard D. Zorowitz, Stephen Ashford, Jorge Jacinto and Alberto Esquenazi are part of the AboLiSh study which is sponsored by Ipsen. Mathieu Beneteau, Pascal Maisonobe, and Christian Hannes are employed by Ipsen.

This study evaluated the effect of time of botulinum toxin A (BoNT-A) treatment on clinical outcomes in adults with post-stroke spasticity (PSS). Individual data were pooled from five studies. Eligible patients received ≥1 BoNT-A injection(s) for PSS and had goal attainment scaling (GAS) scores measured at baseline and 12 weeks. Patients were grouped according to time of treatment post-stroke: early (<1 year) or late (≥1 year). The primary endpoint was the total GAS (GAS-T) score change from baseline to 12 weeks. Secondary outcomes included the proportion of patients with a GAS-T score ≥ 50. Overall, 968 patients were included (166 early and 802 late). Median time post-stroke to BoNT-A treatment was 0.5 (early) versus 5.4 (late) years. Mean (standard deviation [SD]) baseline GAS scores were similar between cohorts (early: 36.9 [3.5]; late: 36.9 [3.6]). The mean (SD) change in the GAS-T score from baseline to 12 weeks was greater in the early versus late cohort (15.7 [8.9] vs. 13.1 [8.9]; p < 0.001). More patients in the early versus late cohort had a GAS-T score ≥ 50 (63.9% vs. 47.4%; p < 0.001) at 12 weeks. No new safety concerns were reported. Early treatment of PSS with BoNT-A has a positive impact on patients’ ability to achieve treatment goals. Plain Language Summary: After a stroke, people can experience muscle stiffness in their limbs, called post-stroke spasticity (PSS), which can lead to pain and make movement difficult. Treatment can include botulinum toxin A (BoNT-A) injections given directly into affected muscles. The aim of our study was to assess whether giving BoNT-A within a year after experiencing a stroke was more effective in treating PSS than delaying treatment. We combined data from 968 patients across five different studies. Most people (802 patients) received BoNT-A treatment 1 year or more after their stroke (late treatment group), while 166 people received treatment within a year of their stroke (early treatment group). In the studies, patients set treatment goals with their physician, for example being able to hold an object or walk a certain distance. After treatment, the extent to which each goal was achieved was assessed and scored based on whether the result was less than expected, as expected, or better than expected by the patient and physician. The scores from the two treatment groups were compared. People in the early treatment group did better in achieving their treatment goals compared with those in the late treatment group. We also looked at any side effects patients experienced. No unexpected side effects were reported. BoNT-A treatment of PSS can help patients achieve their treatment goals, and patients treated early (within 1 year after stroke) may do better than those treated later. This information may help in rehabilitation planning for stroke patients.

Objective: Describe abobotulinumtoxinA (aboBoNT-A) dosing parameters in the real-world management of lower limb spasticity (LLS). Methods: Prospective, observational study (NCT0​4050527) following ambulatory adults with unilateral LLS treated with aboBoNT-A. Results: The effectiveness population included 384 adults with LLS. Across the study, total lower limb doses were higher in patients who received only lower limb injections (n = 131, median 771U) than those who also received ≥ 1 upper limb injection (n = 253, 567U). Total doses increased over subsequent cycles in both subgroups. Six muscles (gastrocnemius medial and lateral heads, soleus muscle, tibialis posterior, flexor digitorum longus, and flexor hallucis longus) were identified as the main targets for the treatment of LLS; other lower limb muscles were injected in fewer than 15% of patients. The most frequent therapy interventions (mean ± SD of 1.8 ± 1.3h/week with a qualified therapist and 5.3 ± 5.9h/week self-rehabilitation in Cycle 1) were task-specific practice, passive stretch, strength training, and positioning. Conclusions: This study demonstrates how a diversity of muscle patterns are currently treated in routine practice where the primary goal was related to the lower limb and highlights important issues for further debate, such as potential underdosing and the need to balance upper and lower limb priorities when devising a treatment plan.

Millions of individuals surviving a stroke have lifelong gait impairments that reduce their personal independence and quality of life. Reduced walking speed is one of the major problems limiting community mobility and reintegration. Previous studies have shown positive effect of robot-assisted gait training utilizing hip exoskeletons for individuals with gait impairments due to a stroke, leading to increased walking speed in post-treatment compared to pre-treatment assessments. However, no evidence emerged of a significant increasing in walking speed attributable to device usage compared to walking without the device. In this pilot investigation, we observed that hip flexion/extension assistance delivered by a portable bilateral powered hip exoskeleton increased overground self-selected walking speed by 20.2 ± 5.0% on average among six chronic post-stroke survivors. When comparing walking with and without the hip exoskeleton within the same experimental session, the observed speed increment resulted in statistically and clinically meaningful improvement (0.14 ± 0.03 m/s > minimal clinically important difference, p = 0.015). The increased walking speed was the result of a higher self-selected cadence and longer step length both on the paretic and nonparetic limbs. By facilitating gait, a bilateral hip exoskeleton could be a viable technology for extending locomotor mobility and facilitating gait training of individuals affected by post-stroke hemiparesis.

BACKGROUND:Calf muscle weakness is a common symptom in slowly progressive neuromuscular disorders that lead to walking problems like instability and increased walking effort. The mainstay of treatment to improve walking in this population is the provision of ankle-foot-orthoses (AFOs). Since we are not aware of an up-to-date and complete overview of the effects of AFOs used for calf muscle weakness in slowly progressive neuromuscular disorders, we reviewed the evidence for the effectiveness of AFOs to improve walking in this patient group, in order to support clinical decision-making. OBJECTIVES:To review the evidence for the effects of ankle-foot orthoses (AFOs) for improving walking in adults with calf muscle weakness due to slowly progressive neuromuscular disorders. SEARCH METHODS:On 10 February 2023, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, ClinicalTrials.gov, and WHO ICTRP. SELECTION CRITERIA:We looked for randomised controlled trials (RCTs), including randomised cross-over studies and quasi-RCTs, and non-randomised studies (NRSs) that examined the effects of AFO interventions compared with shoes-only walking in adults with calf muscle weakness due to neuromuscular disorders. DATA COLLECTION AND ANALYSIS:We used the methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We summarised findings for the primary outcome (objectively measured walking effort, assessed as walking energy cost) and secondary outcomes (perceived walking effort, physical mobility, gait parameters, AFO use, satisfaction with the AFO, and adverse events). We grouped results according to the type of AFO material and synthesised them in meta-analysis where possible. We used the GRADE approach to rate the certainty of the evidence. MAIN RESULTS:We included four randomised cross-over studies and six NRSs with 186 participants in total (the smallest study had 8 participants and the largest had 37). All studies were designed as self-controlled studies and examined the effects of custom-made and/or prefabricated AFOs. The AFOs were made of carbon (5 studies), polypropylene (5 studies), silicone (1 study), metal (1 study), elastic materials (2 studies), or leather combined with other materials (1 study). Outcome measures with AFOs were assessed during a single session (in some studies, people already used the study AFO in daily life), when the AFO was delivered, or at three-week or three-month follow-up. We judged one study to be at moderate risk of bias, and nine studies to be at high or serious risk of bias, primarily due to bias arising from period and carryover effects, selection bias, the inability to blind participants and assessors, missing data, and selective reporting. We found that carbon AFOs may reduce walking energy cost (mean difference (MD) -0.86 J/kg/m, 95% confidence interval (CI) -1.33 to -0.39; 2 studies, 45 participants; low-certainty evidence), and may increase walking speed (MD 0.19 m/s, 95% CI 0.11 to 0.27; 4 studies, 71 participants; low-certainty evidence) compared to shoes-only walking. We found that leather AFOs may increase walking speed (MD 0.25 m/s, 95% CI 0.07 to 0.43; 1 study, 11 participants; low-certainty evidence). Little or no effect on walking speed was found with polypropylene AFOs (MD 0.00 m/s, 95% CI -0.11 to 0.11; 2 studies, 25 participants; low-certainty evidence) and elastic AFOs (MD 0.03 m/s, 95% CI -0.12 to 0.18; 1 study, 14 participants; low-certainty evidence). Carbon AFOs may also enhance satisfaction while walking (1 study, 16 participants; low-certainty evidence). We were unable to draw conclusions about perceived walking effort (one study, 8 participants), balance (two studies, 21 participants), and AFO use (two studies, 51 participants), as the evidence is very uncertain. Finally, two studies (45 participants) reported on adverse events (low-certainty evidence). AUTHORS' CONCLUSIONS:The available evidence for ankle-foot orthoses (AFOs) to improve walking in adults with calf muscle weakness comes from a limited number of small studies with heterogeneity in intervention characteristics and outcome assessment, and is of low to very low certainty. The evidence suggests that carbon AFOs may reduce walking energy cost (effort), increase walking speed, and enhance satisfaction, and leather AFOs may increase walking speed, while polypropylene and elastic AFOs may make little or no difference to walking speed. We are unable to draw conclusions about the effects of AFOs on perceived walking effort, balance, and use. Nor can we draw conclusions about adverse effects of using AFOs. The variety in the findings for AFOs made of different materials suggests further investigation is warranted to explore how different AFO materials impact walking improvement in people with calf muscle weakness due to slowly progressive neuromuscular disorders.

Objective: To assess longitudinal goal attainment with repeat abobotulinumtoxinA (AboBoNT-A) injections for lower limb spasticity (LLS) over 16 months. Design: Prospective, longitudinal, international, multicenter, observational study (NCT04050527). Setting: Specialist neurorehabilitation centers. Participants: Ambulatory adults with unilateral LLS able to take >= 5 steps with/without assistance (effectiveness population, N=384). Interventions: Participants received >= 1 AboBoNT-A treatment cycle administered in accordance with local prescribing guidelines to achieve individualized treatment goals. Main Outcome Measures: The primary endpoint was goal attainment as assessed using the cumulated Goal Attainment Scaling-Leg (GAS-leg) T score, across all treatment cycles for each patient. Results: Overall, participants underwent a median of 5 lower limb injection cycles (median dose 600U, range 100-1475U) with a mean +/- SD injection interval of 18.3 +/- 6.1 weeks. Participants generally achieved their goals as expected over repeated cycles; the mean (95% CI) GAS-leg T score at cycle 1 baseline was 38.0 (37.7, 38.3) and the mean cumulated GAS-leg T score at 16 months was 48.2 (47.4, 48.9) (mean change from a baseline of 9.9 [9.1, 10.7]). Participants injected with a guidance technique at baseline were more likely to attain their cycle 1 primary treatment goals (odds ratio: 1.9 [95% CI 1.1, 3.1], P=.02). Overall, 56 (13.5%) participants reported >= 1 adverse event, of which 6 participants (1.4%) had a treatment-related adverse event. Conclusions: Findings from this large, international study provide evidence for the benefit of repeated cycles of AboBoNT-A for LLS. Multivariate analyses indicated that goal attainment during the first cycle was better with those injected using injection guidance than those injected without guidance. Archives of Physical Medicine and Rehabilitation 2025;106:894-901 (c) 2024 by the American Congress of Rehabilitation Medicine. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)