Combined surveillance and treatment register for children with cerebral palsy: the protocol of the Netherlands CP register.

INTRODUCTION: Cerebral palsy (CP) is a childhood onset, lifelong, condition. Early detection and timely treatment of potential problems during the child's development are important to prevent secondary impairments and improve function. Clinical management of children with CP requires a spectrum of multidisciplinary interventions, which have an impact on short-term and long-term outcomes. However, there is a lack of knowledge about a personalised approach in this heterogeneous population. Various CP registers with different aims have been developed worldwide, which has made an important contribution to our understanding of CP. The purpose of this protocol is to describe the unique design of a combined multidisciplinary surveillance and treatment register for children with CP in the Netherlands, which aims to improve quality of care and to enhance an individual treatment approach. METHODS AND ANALYSIS: The Netherlands CP Register combines a multidisciplinary surveillance programme with a standardised protocol for treatment registry. The register systematically collects real-life surveillance and treatment data of children with CP. The register contributes to daily care at the individual level by screening for potential secondary impairments using a decision-support tool, by visualising individual development using a dashboard, and by supporting goal setting and shared decision-making for interventions. The register provides a platform at the national level for quality of care improvement and a comprehensive database of real-life data allowing multicentre studies with a long-term follow-up. People with lived experience of CP, healthcare professionals from different disciplines and researchers collaborated in the development of the register. ETHICS AND DISSEMINATION: The Netherlands CP register was submitted to the Medical Ethics Review Committee of VU University Medical Center (Amsterdam, the Netherlands), who judged the register not to be subject to the Medical Research Involving Human Subjects Act. A scientific board reviews requests for dissemination of data from the register for specific research questions.

The effect of botulinum toxin-A on neural and non-neural components of wrist hyper-resistance in adults with stroke or cerebral palsy.

BACKGROUND: Botulinum toxin-A (BoNT) is widely used to manage focal upper limb spasticity and is effective in reducing resistance to passive movement, as measured with the modified Ashworth scale. Discrimination and quantification of the underlying neural and non-neural components of hyper-resistance may further improve understanding of the effect of BoNT. OBJECTIVE: To explore the effects of BoNT on neural (NC), non-neural elastic (EC), and viscous (VC) components of resistance to passive wrist extension in adults with stroke or cerebral palsy and the association between the effects on wrist hyper-resistance components and clinical spasticity, pain and motor function scales. DESIGN: Pre-experimental study with pre- and post-intervention measurements at 6 and 12 weeks. SETTING: An outpatient clinic of a hospital. PARTICIPANTS: Adults with chronic stroke or cerebral palsy indicated for BoNT treatment for hyper-resistance in the wrist (N = 18). INTERVENTIONS: BoNT injections in the wrist and/or finger flexor muscles. MAIN OUTCOME MEASURES: Wrist hyper-resistance components, using the NeuroFlexor, and clinical scales (modified Ashworth scale, Tardieu scale, passive wrist extension, pain, Fugl-Meyer motor assessment of the upper extremity, and action research arm test). RESULTS: NC was significantly reduced 6 and 12 weeks post-intervention (median -11.96 Newton, P < .001 and median -9.34 Newton, P = .001, respectively); non-neural EC and VC showed no change. NC reduction 6 weeks post-intervention correlated significantly with BoNT dose (Pearson correlation coefficient rp = -0.56). No significant correlations were found between change scores in wrist hyper-resistance components and clinical scales. CONCLUSIONS: BoNT affected the neural component of resistance to passive wrist extension, while leaving the non-neural elastic and viscous components unaffected. This instrumented approach to quantify the effects of BoNT in the wrist and finger flexor muscles on the components of wrist hyper-resistance may have an added value for BoNT treatment evaluation in clinical practice.

Quantifying neural and non-neural components of wrist hyper-resistance after stroke: Comparing two instrumented assessment methods.

Patients with poor upper limb motor recovery after stroke are likely to develop increased resistance to passive wrist extension, i.e., wrist hyper-resistance. Quantification of the underlying neural and non-neural elastic components is of clinical interest. This cross-sectional study compared two methods: a commercially available device (NeuroFlexor®) with an experimental EMG-based device (Wristalyzer) in 43 patients with chronic stroke. Spearman's rank correlation coefficients (r) between components, modified Ashworth scale (MAS) and range of passive wrist extension (PRoM) were calculated with 95% confidence intervals. Neural as well as elastic components assessed by both devices were associated (r = 0.61, 95%CI: 0.38-0.77 and r = 0.53, 95%CI: 0.28-0.72, respectively). The neural component assessed by the NeuroFlexor® associated significantly with the elastic components of NeuroFlexor® (r = 0.46, 95%CI: 0.18-0.67) and Wristalyzer (r = 0.36, 95%CI: 0.06-0.59). The neural component assessed by the Wristalyzer was not associated with the elastic components of both devices. Neural and elastic components of both devices associated similarly with the MAS (r = 0.58, 95%CI: 0.34-0.75 vs. 0.49, 95%CI: 0.22-0.69 and r = 0.51, 95%CI: 0.25-0.70 vs. 0.30, 95%CI: 0.00-0.55); elastic components associated with PRoM (r = -0.44, 95%CI: -0.65- -0.16 vs. -0.74, 95%CI: -0.85- -0.57 for NeuroFlexor® and Wristalyzer respectively). Results demonstrate that both methods perform similarly regarding the quantification of neural and elastic wrist hyper-resistance components and have an added value when compared to clinical assessment with the MAS alone. The added value of EMG in the discrimination between neural and non-neural components requires further investigation.

Time Course of Wrist Hyper-Resistance in Relation to Upper Limb Motor Recovery Early Post Stroke.

Background. Patients with an upper limb motor impairment are likely to develop wrist hyper-resistance during the first months post stroke. The time course of wrist hyper-resistance in terms of neural and biomechanical components, and their interaction with motor recovery, is poorly understood. Objective. To investigate the time course of neural and biomechanical components of wrist hyper-resistance in relation to upper limb motor recovery in the first 6 months post stroke. Methods. Neural (NC), biomechanical elastic (EC), and viscous (VC) components of wrist hyper-resistance (NeuroFlexor device), and upper limb motor recovery (Fugl-Meyer upper extremity scale [FM-UE]), were assessed in 17 patients within 3 weeks and at 5, 12, and 26 weeks post stroke. Patients were stratified according to the presence of voluntary finger extension (VFE) at baseline. Time course of wrist hyper-resistance components and assumed interaction effects were analyzed using linear mixed models. Results. On average, patients without VFE at baseline (n = 8) showed a significant increase in NC, EC, and VC, and an increase in FM-UE from 13 to 26 points within the first 6 months post stroke. A significant increase in NC within 5 weeks preceded a significant increase in EC between weeks 12 and 26. Patients with VFE at baseline (n = 9) showed, on average, no significant increase in components from baseline to 6 months whereas FM-UE scores improved from 38 to 60 points. Conclusion. Our findings suggest that the development of neural and biomechanical wrist hyper-resistance components in patients with severe baseline motor deficits is determined by lack of spontaneous neurobiological recovery early post stroke.

Is Resting-State EEG Longitudinally Associated With Recovery of Clinical Neurological Impairments Early Poststroke? A Prospective Cohort Study.

Background. The time course of cortical activation and its relation with clinical measures may elucidate mechanisms underlying spontaneous neurobiological recovery after stroke. Objective. We aimed to investigate (1) the time course of cortical activation as revealed by EEG-based spectral characteristics during awake rest and (2) the development of these spectral characteristics in relation to global neurological and upper-limb motor recovery in the first 6 months poststroke. Methods. Resting-state EEG was measured serially in 41 patients after a first-ever ischemic stroke, within 3 and at 5, 12, and 26 weeks poststroke. We computed the brain symmetry index (BSI) and directional BSI (BSIdir) over different frequency bands (1-25 Hz, delta, theta) and delta/alpha ratio (DAR). The National Institutes of Health Stroke Scale (NIHSS) and Fugl-Meyer motor assessment of the upper extremity (FM-UE) were determined as clinical reflections of spontaneous neurobiological recovery. Longitudinal changes in spectral characteristics and within- and between-subject associations with NIHSS and FM-UE were analyzed with linear mixed models. Results. Spectral characteristics showed a gradual normalization over time, within and beyond 12 weeks poststroke. Significant within- and between-subject associations with NIHSS were found for DAR of the affected hemisphere (DARAH) and BSIdirdelta. BSIdirdelta also demonstrated significant within- and between-subject associations with FM-UE. Conclusions. Changes in spectral characteristics are not restricted to the time window of recovery of clinical neurological impairments. The present study suggests that decreasing DARAH and BSIdirdelta reflect improvement of global neurological impairments, whereas BSIdirdelta was also specifically associated with upper-limb motor recovery early poststroke.

Measurement Properties of the NeuroFlexor Device for Quantifying Neural and Non-neural Components of Wrist Hyper-Resistance in Chronic Stroke.

Introduction: Differentiating between the components of wrist hyper-resistance post stroke, i.e., pathological neuromuscular activation ("spasticity") and non-neural biomechanical changes, is important for treatment decisions. This study aimed to assess the reliability and construct validity of an innovative measurement device that quantifies these neural and non-neural components by biomechanical modeling. Methods: Forty-six patients with chronic stroke and 30 healthy age-matched subjects were assessed with the NeuroFlexor, a motor-driven device that imposes isokinetic wrist extensions at two controlled velocities (5 and 236°/s). Test-retest reliability was evaluated using intraclass correlation coefficients (ICC) and smallest detectable changes (SDC), and construct validity by testing the difference between patients and healthy subjects and between subgroups of patients stratified by modified Ashworth scale (MAS), and the association with clinical scales. Results: Test-retest reliability was excellent for the neural (NC) and non-neural elastic (EC) components (ICC 0.93 and 0.95, respectively), and good for the viscous component (VC) (ICC 0.84), with SDCs of 10.3, 3.1, and 0.5 N, respectively. NC and EC were significantly higher in patients compared to healthy subjects (p < 0.001). Components gradually increased with MAS category. NC and EC were positively associated with the MAS (r s 0.60 and 0.52, respectively; p < 0.01), and NC with the Tardieu scale (r s 0.36, p < 0.05). NC and EC were negatively associated with the Fugl-Meyer Assessment of the upper extremity and action research arm test (r s ≤ -0.38, p < 0.05). Conclusions: The NeuroFlexor reliably quantifies neural and non-neural components of wrist hyper-resistance in chronic stroke, but is less suitable for clinical evaluation at individual level due to high SDC values. Although construct validity has been demonstrated, further investigation at component level is needed.

Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis.

OBJECTIVE: To provide a comprehensive overview of reported effects and scientific robustness of botulinum toxin (BoNT) treatment regarding the main clinical goals related to poststroke upper limb spasticity, using the International Classification of Functioning, Disability and Health. DATA SOURCES: Embase, PubMed, Wiley/Cochrane Library, and Ebsco/CINAHL were searched from inception up to May 16, 2018. STUDY SELECTION: We included randomized controlled trials comparing upper limb BoNT injections with a control intervention in patients with a history of stroke. A total of 1212 unique records were screened by 2 independent reviewers. Forty trials were identified, including 2718 patients with history of stroke. DATA EXTRACTION: Outcome data were pooled according to assessment timing (ie, 4-8wk and 12wk after injection), and categorized into 6 main clinical goals (ie, spasticity-related pain, involuntary movements, passive joint motion, care ability, arm and hand use, and standing and walking performance). Sensitivity analyses were performed for the influence of study and intervention characteristics, involvement of pharmaceutical industry, and publication bias. DATA SYNTHESIS: Robust evidence is shown for the effectiveness of BoNT in reducing resistance to passive movement, as measured with the (Modified) Ashworth Score, and improving self-care ability for the affected hand and arm after intervention (P<.005) and at follow-up (P<.005). In addition, robust evidence is shown for the absence of effect on arm-hand capacity at follow-up. BoNT was found to significantly reduce involuntary movements, spasticity-related pain, and caregiver burden, and improve passive range of motion, while no evidence was found for arm and hand use after intervention. CONCLUSIONS: In view of the robustness of current evidence, no further trials are needed to investigate BoNT for its favorable effects on resistance to passive movement of the spastic wrist and fingers, and on self-care. No trials are needed to further confirm the lack of effects of BoNT on arm-hand capacity, whereas additional trials are needed to establish the suggested favorable effects of BoNT on other body functions, which may result in clinically meaningful outcomes at activity and participation levels.

Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients.

PURPOSE: To evaluate tolerance of a new dynamic hand-wrist orthosis and effectiveness on the prevention of progressive wrist contracture and spasticity after stroke. METHOD: Chronic stroke patients (N = 6) with upper limb spasticity, who had not been able to endure a static orthosis, were provided with a custom-made dynamic orthosis. Tolerance of the orthosis was evaluated by the daily wearing time, and self-reported pain and spasticity. Effectiveness was measured by contracture of wrist and finger flexor muscles, upper limb spasticity and use of spasticity treatment. Outcome measures were collected at time of fitting of the dynamic orthosis (baseline) and after three and six months. RESULTS: Five patients could endure the dynamic orthosis without discomfort for 6 hours daily during the 6-month period. Self-reported spasticity and pain decreased significantly (p < 0.05) compared to wearing the static orthosis. In comparison to baseline, the maximum passive wrist extension increased significantly from -29° to -12° (p < 0.05). Although, no significant change in spasticity was measured, the use of Botulinum Toxin injections decreased for two patients. CONCLUSIONS: The majority of the included chronic stroke patients tolerated the new dynamic orthosis for at least 6 hours daily and the use significantly reduced wrist contractures in a 6-month period.

Long-term use of a static hand-wrist orthosis in chronic stroke patients: a pilot study.

Background. Long-term splinting, using static orthoses to prevent contractures, is widely accepted in stroke patients with paresis of the upper limb. A number of stroke patients complain about increased pain and spasticity, which leads to the nonuse of the orthosis and a risk of developing a clenched fist. Objectives. Evaluating long-term use of static hand-wrist orthoses and experienced comfort in chronic stroke patients. Methods. Eleven stroke patients who were advised to use a static orthosis for at least one year ago were included. Semistructured telephone interviews were conducted to explore the long-term use and experienced comfort with the orthosis. Data were analyzed using descriptive statistics. Results. After at least one year, seven patients still wore the orthosis for the prescribed hours per day. Two patients were unable to wear the orthosis 8 hours per day, due to poor comfort. Two patients stopped using the orthosis because of an increase in spasticity or pain. Conclusions. These pilot data suggest that a number of stroke patients cannot tolerate a static orthosis over a long-term period because of discomfort. Without appropriate treatment opportunities, these patients will remain at risk of developing a clenched fist and will experience problems with daily activities and hygiene maintenance.