Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study.
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ABSTRACT: Objective
To identify predictors and the optimal time point for the early prediction of the presence and severity of spasticity in the upper limb 12 months poststroke.Methods
In total, 117 patients in the Gothenburg area who had experienced a stroke for the first time and with documented arm paresis day 3 poststroke were consecutively included. Assessments were made at admission and at 3 and 10 days, 4 weeks, and 12 months poststroke. Upper limb spasticity in elbow flexion/extension and wrist flexion/extension was assessed with the modified Ashworth Scale (MAS). Any spasticity was regarded as MAS ≥1, and severe spasticity was regarded as MAS ≥2 in any of the muscles. Sensorimotor function, sensation, pain, and joint range of motion in the upper limb were assessed with the Fugl-Meyer assessment scale, and, together with demographic and diagnostic information, were included in both univariate and multivariate logistic regression analysis models. Seventy-six patients were included in the logistic regression analysis.Results
Sensorimotor function was the most important predictor both for any and severe spasticity 12 months poststroke. In addition, spasticity 4 weeks poststroke was a significant predictor for severe spasticity. The best prediction model for any spasticity was observed 10 days poststroke (85% sensitivity, 90% specificity). The best prediction model for severe spasticity was observed 4 weeks poststroke (91% sensitivity, 92% specificity).Conclusions
Reduced sensorimotor function was the most important predictor both for any and severe spasticity, and spasticity could be predicted with high sensitivity and specificity 10 days poststroke.
SUBMITTER: Opheim A
PROVIDER: S-EPMC4560058 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe purpose was to explore if there are differences in extent of change in upper extremity motor function and activity capacity, in persons with ischaemic versus haemorrhagic stroke, during the first year post stroke.Patients and methodsOne hundred seventeen persons with stroke (ischaemic n = 98, haemorrhagic n = 19) and reduced upper extremity function 3 days after onset were consecutively included to the Stroke Arm Longitudinal Study at the University of Gothenburg (SALGOT) from a stroke unit. Upper extremity motor function (Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)) and activity capacity (Action Research Arm Test (ARAT)) were assessed at 6 assessments during the first year; age and initial stroke severity were recorded. Differences between groups in extent of change over time of upper extremity motor function and activity capacity were analysed with mixed models repeated measurements method.ResultsSignificant improvements were found in function and activity in both groups within the first month (p = 0.001). Higher age and more severe stroke had a negative impact on recovery in both groups. Larger improvements of function and activity were seen in haemorrhagic stroke compared to ischaemic, both from 3 days to 3- and 12 months, and from 1 month to 3 months. Both groups reached similar levels of function and activity at 3 months post stroke.ConclusionAlthough persons with haemorrhagic stroke had initially lower scores than those with ischaemic stroke, they had a larger improvement within the first 3 months, and thereafter both groups had similar function and activity.
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Project description:The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2⁻12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies.
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Project description:BackgroundEffective rehabilitative therapies are needed for patients with long-term deficits after stroke.MethodsIn this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.ResultsAt 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.ConclusionsIn patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)
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Project description:BackgroundFor early prediction of upper extremity function, there is a need for short clinical measurements suitable for acute settings. Previous studies demonstrate correct prediction of function, but have ether included a complex assessment procedure or have an outcome that does not automatically correspond to motor function required to be useful in daily activity. The purpose of this study was to investigate whether a sub-set of items from the Action Research Arm Test (ARAT) at 3 days and 1 month post-stroke could predict the level of upper extremity motor function required for a drinking task at three later stages during the first year post-stroke.MethodsThe level of motor function required for a drinking task was identified with the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). A structured process was used to select ARAT items not requiring special equipment and to find a cut-off level of the items' sum score. The early prognostic values of the selected items, aimed to determine the level of motor function required for a drinking task at 10 days and 1 and 12 months, were investigated in a cohort of 112 patients. The patients had a first time stroke and impaired upper extremity function at day 3 after stroke onset, were ≥18 years and received care in a stroke unit.ResultsTwo items, "Pour water from glass to glass" and "Place hand on top of head", called ARAT-2, met the requirements to predict upper extremity motor function. ARAT-2 is a sum score (0-6) with a cut-off at 2 points, where >2 is considered an improvement. At the different time points, the sensitivity varied between 98% and 100%, specificity between 73% and 94%. Correctly classified patients varied between 81% and 96%.ConclusionsUsing ARAT-2, 3 days post-stroke could predict the level of motor function (assessed with FMA-UE) required for a drinking task during the first year after a stroke. ARAT-2 demonstrates high predictive values, is easily performed and has the potential to be clinically feasible.Trail registrationClinicalTrials.gov: NCT01115348.
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Project description:IntroductionEfficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.MethodsSubjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). Doses for non-primary patterns were flexible within predefined ranges.ResultsAt week 4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth scale (AS) scores than placebo [least-squares mean change ± standard error: -0.9 ± 0.06 (n = 171) vs. -0.5 ± 0.08 (n = 88); P < 0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than with placebo (37.5%; P < 0.001). Investigator's Global Impression of Change confirmed superiority of incobotulinumtoxinA vs. placebo (P = 0.003). IncobotulinumtoxinA was associated with functional improvements, as demonstrated in responder rates for Disability Assessment Scale principal target at week 4 (P = 0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) of subjects.ConclusionsIncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated.
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Project description:BackgroundReduction of compensation and improved movement quality indicate recovery after stroke. Since clinical measures alone are often inadequate to distinguish between behavioral recovery and compensation, kinematic analysis of functional tasks has been recommended.ObjectiveTo quantify longitudinal changes and residual deficits in movement performance and quality during the first year after stroke using kinematic analysis of drinking task.MethodsA total of 56 participants with first ever stroke causing upper extremity impairment were extracted from a non-selected stroke unit cohort (Stroke Arm Longitudinal Study at the University of Gothenburg-SALGOT). Participants needed to able to perform the drinking task with the more-affected arm at least on 2 occasions out of 6 (3 days, 10 days, 4 weeks, and 3, 6, and 12 months) during the first year to be included. A cohort of 60 healthy individuals was used as reference. Longitudinal changes were analyzed using linear mixed models.ResultsMovement time, number of movement units, peak angular velocity of the elbow, peak hand velocity, and trunk displacement improved significantly over the first 3 months with a peak at 6 months. Movement time and peak hand velocity reached levels comparable to healthy at 3 months, but number of movement units, peak elbow angular velocity, trunk displacement, and arm abduction remained different from healthy over the first year after stroke.ConclusionsEven when the recovery patterns of kinematics follow the known nonlinear pattern, not all kinematic measures reach the levels in par with healthy controls at one year post stroke. Since the number of movement units, peak angular velocity, trunk displacement, and arm abduction remained impaired over the first year, they might be the most suited measures to distinguish behavioral recovery from compensation strategies.Trial registrationClinicalTrials: NCT01115348. 4 May 2010. Retrospectively registered.
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Project description:ObjectiveTo investigate the efficacy and safety of Tui Na for treating spasticity of the upper limbs of stroke patients.DesignA prospective, multicenter, blinded, randomized controlled intervention study.SubjectsStroke patients with upper limb spasticity who were treated between December 2013 and February 2017 in 16 participating institutions in China were randomly assigned to receive either Tui Na plus conventional rehabilitation (Tui Na group, n = 222,) or conventional rehabilitation only (control group, n = 222).MethodsEligible adult patients (aged 18-75 years) were enrolled 1-12 months after stroke and randomly allocated in a 1:1 ratio to the two groups. Outcome assessors were blinded to treatment allocation. Muscle tone in the spastic muscles was evaluated using the Modified Ashworth Scale (MAS), and the primary endpoint was the change in MAS score over 4 weeks of treatment.ResultsAmong patients who had experienced stroke 1-3 months before treatment, the Tui Na group experienced significantly greater reductions in MAS scores for three muscle groups than did the control group after 4 weeks of treatment. These improvements were sustained at the 3- and 6-month follow-ups. However, among patients who suffered from stroke 4-6 months and 7-12 months before treatment, the change in MAS with treatment did not differ significantly between those who did and those who did not receive Tui Na. No Tui Na-related adverse events during treatment were reported the groups.ConclusionTui Na was effective and safe for alleviating poststroke spasticity within 1-3 months after stroke onset.
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Project description:PurposeThe open-label phase 3 "Treatment with IncobotulinumtoxinA in Movement Open-Label" (TIMO) study investigated longer-term safety and efficacy of incobotulinumtoxin A in children/adolescents with cerebral palsy (CP).MethodsPatients on standard treatment, with unilateral or bilateral lower limb (LL) or combined upper limb (UL)/LL spasticity received four incobotulinumtoxinA injection cycles (16 or 20 Units/kg bodyweight total [maximum 400 or 500 Units] per cycle depending on ambulatory status/clinical pattern treated), each followed by 12-16 weeks' observation. Treatment for pes equinus was mandatory; flexed knee or adducted thigh were options for unilateral treatment and/or ULs for unilateral/bilateral treatment. The primary endpoint was safety; changes in Ashworth Scale and Gross Motor Function Measure-66 scores, and Global Impression of Change Scale scores at week 4 of each injection cycle were also evaluated.ResultsIncobotulinumtoxinA (≤500 Units for ≤98 weeks) was safe, well-tolerated, and effective across all endpoints for multipattern treatment of LL and combined LL/UL spasticity in ambulant/nonambulant children/adolescents with CP. Treatment effects increased with each injection cycle. No new/unexpected safety concerns were identified.ConclusionIncobotulinumtoxinA showed a good safety and tolerability profile, with efficacy over multiple clinical presentations. As an adjunct treatment, it offers an effective, individualized treatment option for pediatric CP-related spasticity.
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Project description:Background: Recent studies of botulinum toxin for post-stroke spasticity indicate potential benefits of early treatment (i. e., first 6 months) in terms of developing hypertonicity, pain and passive function limitations. This non-interventional, longitudinal study aimed to assess the impact of disease duration on the effectiveness of abobotulinumtoxinA treatment for upper limb spasticity. Methods: The early-BIRD study (NCT01840475) was conducted between February 2013 and 2018 in 43 centers across Germany, France, Austria, Netherlands and Switzerland. Adult patients with post-stroke upper limb spasticity undergoing routine abobotulinumtoxinA treatment were followed for up to four treatment cycles. Patients were categorized by time from stroke event to first botulinum toxin-A treatment in the study (as defined by the 1st and 3rd quartiles time distribution) into early-, medium- and late- start groups. We hypothesized that the early-start group would show a larger benefit (decrease) as assessed by the modified Ashworth scale (MAS, primary endpoint) on elbow plus wrist flexors compared with the late-start group. Results: Of the 303 patients enrolled, 292 (96.4%) received ≥1 treatment and 186 (61.4%) received 4 injection cycles and completed the study. Patients in all groups showed a reduction in MAS scores from baseline over the consecutive injection visits (i.e., at end of each cycle). Although reductions in MAS scores descriptively favored the early treatment group, the difference compared to the late group did not reach statistical significance at the last study visit (ANCOVA: difference in adjusted means of 0.15, p = 0.546). Conclusions: In this observational, routine-practice study, patients in all groups displayed a benefit from abobotulinumtoxinA treatment, supporting the effectiveness of treatment for patients at various disease stages. Although the data revealed some trends in favor of early vs. late treatment, we did not find strong evidence for a significant benefit of early vs. late start of treatment in terms of reduction in MAS scores.
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Project description:Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness.We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization.A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different.The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.
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