Observational Gait Scale Research Articles

Efficacy of neuromuscular electrical stimulation and interrupted serial casting in children with spastic diplegia

ObjectivesThis research was aimed at comparing the effects of neuromuscular electrical stimulation (NMES) combined with interrupted serial casting (SC) versus SC alone on various aspects of lower limb function in children with diplegic cerebral palsy. SC is a clinical technique used to increase passive range of motion (ROM), decrease hypertonicity, and improve walking in children with cerebral palsy (CP). MethodsThis randomized comparative trial involved 33 children with diplegic CP, who were randomly assigned to group A or group B at recruitment. Group A received SC along with a customized physical therapy program, whereas group B received the same interventions as group A along with NMES applied through cast windows during casting. Evaluations were based on ROM, the Modified Tardieu Scale, handheld dynamometer measurements, and the Observational Gait Scale. Assessments were conducted before and after 8 weeks of intervention. ResultsBoth groups exhibited significant improvements in dorsiflexion ROM, popliteal angle, gastrocnemius dynamic spasticity, and hamstring dynamic spasticity after the intervention (P = 0.0001 for all). However, significant differences (P < 0.05) in dorsiflexor strength, knee extensor strength, and observational gait scale score were observed between groups after the intervention, favoring group B. ConclusionsThe use of NMES during SC may help overcome the substantial decrease in strength resulting from casting, thus achieving less reduction of tone, improving ROM without significantly decreasing strength, and attaining greater improvements in gait function.

Comparison of Percutaneous Versus Open Hamstring Lengthening in Patients of Spastic Diplegic Cerebral Palsy - A Randomized Controlled Trial.

Cerebral palsy (CP) often manifests with crouch gait due to hamstring spasticity, necessitating surgical intervention like hamstring lengthening surgery. Percutaneous techniques are emerging as an alternative to traditional open approaches in orthopedic surgeries. This randomized controlled trial aimed to compare the outcomes of percutaneous hamstring lengthening (pHSL) versus open hamstring lengthening (oHSL) in pediatric patients with spastic diplegic CP, focusing on improvements in gait and knee function. One hundred children diagnosed with spastic diplegic CP were randomized into pHSL (n = 50) and oHSL (n = 50) groups. Surgical procedures were performed using single-event multilevel surgery techniques. Pre-operative and post-operative assessments included range of motion, popliteal angle, gross motor function classification system (GMFCS) score, and gait analysis (functional independence measure [FIM], observational gait scale [OGS], physician gait scale). Statistical analyses were conducted using Statistical Packages for the Social Sciences v25. Both pHSL and oHSL groups showed significant improvements in popliteal angle and GMFCS scores postoperatively (P < 0.001 within each group). However, there were no significant differences between the groups in terms of these outcomes (P > 0.05). FIM, OGS, and physician gait scale also showed comparable improvements between groups (P > 0.05). pHSL is as effective as oHSL in improving gait and knee function in pediatric patients with spastic diplegic CP. The percutaneous approach offers a safe and efficient alternative to traditional open surgery, potentially minimizing muscle damage and promoting quicker recovery.

Inter- and intra-rater reliability of new application software for computerised paediatric version of Wisconsin Gait Scale

The paediatric version of Wisconsin Gait Scale (WGS) is a reliable tool for gait assessment in children with spastic hemiplegic cerebral palsy (CP). We decided to develop a solution which will make it possible to objectify the descriptive paediatric version of the WGS, and which, consequently, will allow researchers/clinicians to more easily perform accurate assessment of gait patterns in patients. The aim of the study was to assess inter- and intra-rater reliability of new application software for computerised paediatric version of the WGS in children with hemiplegic CP. The study involved 31 children with hemiplegic CP. The app was designed using a model based on thematic categories of the paediatric WGS, and utilising auxiliary lines between specific points on the patient’s body, and taking into account angular values, duration and length of the specific gait phases, in order to enable acquisition of quantitative data corresponding to the components of the WGS. The gait of the study participants was recorded, in series of videos. These provided material for three independent raters who reviewed the recordings twice and assessed the participants’ gait using the app. After the evaluation was completed, the data were retrieved from the software. The new application software for the computerised paediatric WGS presents very good inter- and intra-rater reliability. Intra-class correlation coefficient (ICC) was very high in measurement 1 (ICC > 0.9) and 2 (ICC > 0.8), which reflects a very high degree of agreement between the three examiners; there was also high agreement for the specific examiners, between the two measurements (ICC > 0.9). The observational gait scale, objectified through the new software, and enabling computer-aided use of the paediatric WGS, presents practical advantages for examiners since it facilitates decisions taken in the process of WGS-based assessment in children with spastic hemiplegic CP.

Present and future of gait assessment in clinical practice: Towards the application of novel trends and technologies.

Despite being available for more than three decades, quantitative gait analysis remains largely associated with research institutions and not well leveraged in clinical settings. This is mostly due to the high cost/cumbersome equipment and complex protocols and data management/analysis associated with traditional gait labs, as well as the diverse training/experience and preference of clinical teams. Observational gait and qualitative scales continue to be predominantly used in clinics despite evidence of less efficacy of quantifying gait. This study provides a scoping review of the status of clinical gait assessment, including shedding light on common gait pathologies, clinical parameters, indices, and scales. We also highlight novel state-of-the-art gait characterization and analysis approaches and the integration of commercially available wearable tools and technology and AI-driven computational platforms. A comprehensive literature search was conducted within PubMed, Web of Science, Medline, and ScienceDirect for all articles published until December 2021 using a set of keywords, including normal and pathological gait, gait parameters, gait assessment, gait analysis, wearable systems, inertial measurement units, accelerometer, gyroscope, magnetometer, insole sensors, electromyography sensors. Original articles that met the selection criteria were included. Clinical gait analysis remains highly observational and is hence subjective and largely influenced by the observer's background and experience. Quantitative Instrumented gait analysis (IGA) has the capability of providing clinicians with accurate and reliable gait data for diagnosis and monitoring but is limited in clinical applicability mainly due to logistics. Rapidly emerging smart wearable technology, multi-modality, and sensor fusion approaches, as well as AI-driven computational platforms are increasingly commanding greater attention in gait assessment. These tools promise a paradigm shift in the quantification of gait in the clinic and beyond. On the other hand, standardization of clinical protocols and ensuring their feasibility to map the complex features of human gait and represent them meaningfully remain critical challenges.

Update on an Observational, Clinically Useful Gait Coordination Measure: The Gait Assessment and Intervention Tool (G.A.I.T.).

With discoveries of brain and spinal cord mechanisms that control gait, and disrupt gait coordination after disease or injury, and that respond to motor training for those with neurological disease or injury, there is greater ability to construct more efficacious gait coordination training paradigms. Therefore, it is critical in these contemporary times, to use the most precise, sensitive, homogeneous (i.e., domain-specific), and comprehensive measures available to assess gait coordination, dyscoordination, and changes in response to treatment. Gait coordination is defined as the simultaneous performance of the spatial and temporal components of gait. While kinematic gait measures are considered the gold standard, the equipment and analysis cost and time preclude their use in most clinics. At the same time, observational gait coordination scales can be considered. Two independent groups identified the Gait Assessment and Intervention Tool (G.A.I.T.) as the most suitable scale for both research and clinical practice, compared to other observational gait scales, since it has been proven to be valid, reliable, sensitive to change, homogeneous, and comprehensive. The G.A.I.T. has shown strong reliability, validity, and sensitive precision for those with stroke or multiple sclerosis (MS). The G.A.I.T. has been translated into four languages (English, Spanish, Taiwanese, and Portuguese (translation is complete, but not yet published)), and is in use in at least 10 countries. As a contribution to the field, and in view of the evidence for continued usefulness and international use for the G.A.I.T. measure, we have provided this update, as well as an open access copy of the measure for use in clinical practice and research, as well as directions for administering the G.A.I.T.

Carbon Fiber Two-Pull Solid Ankle-Foot Orthoses versus Serial Casting in the Treatment of Idiopathic Toe Walking with Ankle Equinus Contracture

ABSTRACT Introduction Idiopathic toe walking (ITW) is a common pediatric diagnosis. Serial casting, a common treatment used for an ankle equinus contracture, may not be appropriate for all children. This pilot study investigated whether carbon fiber two-pull solid ankle-foot orthoses (CTP-AFOs) would have similar outcomes as serial casting in the treatment of children with a diagnosis of ITW and ankle equinus contracture. Materials and Methods Children with ITW (n = 35) were randomized to receive CTP-AFOs or serial casting. Assessments were at initial, posttreatment, and 4-month follow-up with therapy protocols until posttreatment. Results There was no statistical difference in active (&lt;0.001) and passive (&lt;0.001) dorsiflexion range of motion, the Observational Gait Scale (&lt;0.001), the Pediatric Reach Test (&lt;0.01) popliteal range of motion (&lt;0.001), strength in dorsiflexion (&lt;0.001) and plantarflexion (0.21), and the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (0.31). Both groups demonstrated significant improvement over time with therapeutic intervention performed by a physical therapist. Conclusions Carbon fiber two-pull solid ankle-foot orthoses are a noninferior alternative to serial casting in a population with ITW and ankle equinus contracture. Therapeutic interventions for treatment of ITW and ankle equinus contracture have demonstrated improvements in motor outcomes.

Assessment of Agreement Between a New Application to Compute the Wisconsin Gait Score and 3-Dimensional Gait Analysis, and Reliability of the Application in Stroke Patients.

Currently, there are no computerized tools enabling objective interpretation of observational gait assessment based on Wisconsin Gait Scale (WGS), which is a reliable and well-tested tool. The solution envisaged by us may provide a practical tool for assessing gait deviations in patients with hemiparesis after stroke. The present study assessed agreement between a new application software for computerized WGS and 3-dimensional gait analysis (3DGA), and reliability of the application. The study involved 33 individuals with hemiparesis after stroke. The software was developed based on a model designed taking into account components of the WGS and incorporating auxiliary lines passing through the relevant anthropometric points on the patient’s body, as well as measurements of angular values, distances and duration of the specific gait phases, which make it possible to substantiate assessment based on this scale. Series of videos were made to record gait of the qualified patients. After the gait evaluation was carried out using the app, the data were retrieved from the software. The gait assessment was performed separately by three independent examiners who reviewed the video recording using the new app twice (two weeks apart). Additionally, 3DGA was carried out for all the subjects, and the results of the app-aided assessment were compared to those acquired using 3DGA. The findings show statistically significant correlations (p < 0.05) between majority of the WGS items measured using the new app, and the relevant spatiotemporal and kinematic parameters identified by 3DGA. Agreement between the scores reported by the three examiners was high in both measurements, as reflected by Cronbach’s alpha exceeding 0.8. The findings reflect very good intra-observer reliability (as reflected by kappa coefficients from 0.847 to 1) and inter-observer reliability (as reflected by kappa coefficients from 0.634 to 1) of the new application software for computerized WGS. The opportunities offered by the observational gait scale objectified through our new software for computerized WGS result from the fact that the tool provides a useful low-cost and time-effective feedback to monitor ongoing treatments or formulate hypotheses.

Effects of modified pilates on trunk, postural control, gait and balance in children with cerebral palsy: a single-blinded randomized controlled study.

This study aimed to determine the effects of modified pilates exercises (MPE) and neurodevelopmental therapy (NDT) on trunk, postural control, gait, and balance in children with cerebral palsy (CP). 18 children with CP between gross motor function classification system (GMFCS) I and III were randomized into two groups as study (Group A, MPE) and control (Group B, NDT). Physiotherapy (PT) took place 2days a week for 8weeks. Trunk control measurement scale (TCMS), seated postural control measurement (SPCM), pediatric reach test (PRT), pediatric berg balance measurement (PBBM), 6 minute walking test (6MWT), observational gait scale (OGS), core stability performance measurements, and muscle strength tests were performed. Mean age of group A (n = 9) was 9 ± 1.58years, and group B (n = 9) was 10 ± 2.73years. Significant differences were found in the SPCM posture (p = 0.000), TCMS (p = 0.004), OGS right (p = 0.019) and left (p = 0.001) scores, abdominal fatigue test (AFT) (p = 0.014), modified side bridge (MSBT) test (right p = 0.04, left p = 0.031), pressure biofeedback unit test (PBU) (p = 0.024), and sit-ups test (SUT) (p = 0.011) in favor of group A. According to the initial measurements of the percentage changes of the tests, significantly difference was found in PBBMR (p = 0.001), PBBML (p = 0.000), SPCM posture (0.001), TCMS (0.000), MBSTET (0.000), MSBT left (p = 0.034), AFT (p = 0.002), PBU (p = 0.015), SUT (p = 0.000), MPUT (p = 0.018), and OGS right (p = 0.029) in favor of group A. The results revealed that MPEs in children with CP positively affects trunk, postural control, gait, and balance compared to NDT. It is concluded that MPE can be used as an alternative treatment approach in children with CP. TRIAL REGISTRATION NUMBER/DATE OF REGISTRATION/STUDY START DATE/URL OF THE RECORD: NCT04035954/ 24/07/2019/ August 1, 2019/ https://clinicaltrials.gov/ct2/show/NCT04035954 .

The Observational Gait Scale Can Help Determine the GMFCS Level in Children With Cerebral Palsy.

To evaluate the association between the Observational Gait Scale (OGS) and the Gross Motor Function Classification System (GMFCS) in walking children with cerebral palsy (CP). The charts of 512 children with CP GMFCS levels I to IV were reviewed for the OGS score and GMFCS level at their initial visit. The OGS score decreased with increasing GMFCS levels. The average OGS for GMFCS level I was 13.1 (2.8), level II was 11.3 (2.7), level III was 7.7 (2.7), and level IV was 6.1 (2.0). A significant negative relationship was seen between the OGS and the GMFCS. In particular, each GMFCS level was different across all levels in a pairwise comparison. In addition, multivariate modeling analysis confirmed that the association between the OGS and the GMFCS was still valid, after adjusting for age and gender. The OGS is a quick tool to rate gait and help confirm a child's GMFCS level.

Commentary on "The Observational Gait Scale Can Help Determine the GMFCS Level in Children With Cerebral Palsy".

Commentary on "The Observational Gait Scale Can Help Determine the GMFCS Level in Children With Cerebral Palsy".

Pelvis-Toe Distance: 3-Dimensional Gait Characteristics of Functional Limb Shortening in Hemiparetic Stroke.

We aimed to investigate whether a newly defined distance in the lower limb can capture the characteristics of hemiplegic gait compared to healthy controls. Three-dimensional gait analyses were performed on 42 patients with chronic stroke and 10 age-matched controls. Pelvis-toe distance (PTD) was calculated as the absolute distance between an anterior superior iliac spine marker and a toe marker during gait normalized by PTD in the bipedal stance. The shortening peak during the swing phase was then quantified as PTDmin. The sagittal clearance angle, the frontal compensatory angle, gait speed, and the observational gait scale were also collected. PTDmin in the stroke group showed less shortening on the affected side and excessive shortening on the non-affected side compared to controls. PTDmin on the affected side correlated negatively with the sagittal clearance peak angle and positively with the frontal compensatory peak angle in the stroke group. PTDmin in stroke patients showed moderate to high correlations with gait speed and observational gait scale. PTDmin adequately reflected gait quality without being affected by apparent improvements due to frontal compensatory patterns. Our results showed that various impairments and compensations were included in the inability to shorten PTD, which can provide new perspectives on gait rehabilitation in stroke patients.

Construct Validity of the Gait Assessment and Intervention Tool (GAIT) in People With Multiple Sclerosis.

In clinical practice, observational scales are the most common approach used to assess gait pattern in people with neurological disorders. The Gait Assessment and Intervention Tool (GAIT) is an observational gait scale, and it has proved to be the most comprehensive, homogeneous, and objective of all the observational gait scales studied in people with neurological conditions. To study the construct validity of the GAIT in people with multiple sclerosis (MS). An observational study was conducted. Multiple Sclerosis Foundation in Madrid (Spain). Thirty-five patients with MS were assessed. GAIT construct validity was assessed using the following scales: Rivermead Visual Gait Assessment (RVGA), Tinetti Gait Scale (TGS), 10-Meter Walking Test (10MWT), Timed Up&Go (TUG), Hauser Ambulatory Index (HAI), Multiple Sclerosis Walking Scale-12 (MSWS-12), Functional Gait Assessment (FGA), Modified Ashworth Scale (MAS), and Rivermead Mobility Index (RMI). A total of 35 subjects with MS were assessed. The correlations between the GAIT and the RVGA were excellent (r > .90) and moderate with TGS (values between -.62 and -.59). Correlations with HAI, FGA, MSWS-12, and RMI were moderate (with values between .57 and .67). Correlations were lower for the velocity scales TUG and MAS. The construct validity of the GAIT is high, as a measure of gait coordination in people with MS. Specifically, there was excellent correlation with the RVGA. There was a moderate correlation for the GAIT with measures of functional mobility, but a lesser correlation of the GAIT with measures restricted to temporal gait characteristics (speed measures) or measurements of impairments underlying gait patterns such as balance or muscle tone.

FAMILY-CENTRED, GOAL-DIRECTED MULTIDISCIPLINARY APPROACH FOR LOWER EXTREMITY BOTULINUM TOXIN WITH PHYSICAL THERAPY AND REHABILITATION IN CEREBRAL PALSY

Purpose: This study aimed to investigate lower extremity botulinum toxin (BT) and physical therapy and rehabilitation (PTR) application scoping “family-centered, goal-directed multidisciplinary approach (FGMA)” in the children with cerebral palsy (CP) and to assess the satisfaction of parents and children from this approach. Methods: A physician and physiotherapist evaluated 30 children (age=6.33±2.38 years) with ambulatory CP and their parents using the FGMA. Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS) were used to define the functionality of children. Selectivity was assessed using the Selective Control Assessment of the Lower Extremity (SCALE). Walking was evaluated using the Observational Gait Scale (OGS) and the Gillette Functional Assessment Questionnaire (FAQ). Satisfaction levels marked on the Visual Analogue Scale. Results: Nineteen (63%) children were GMFCS level III, 16 (53%) children were MACS level I, 19 (63.33%) children were CFCS level I. Half of children had visual problems. While the most preferred muscles were hamstring and gastrocnemius for BT, the most common device was ankle-foot orthosis. The median score of SCALE, OGS, and FAQ, and the satisfaction of parents and children were 8 (4-17), 12 (2-24), 2 (1-10), 9 (7-10), and 7 (6-10) points, respectively. The satisfaction level of parents with the new approach was higher than the previous traditional approach (p&amp;lt;0.001). Conclusions: Both the parents and children may be satisfied with the FGMA for BT with the PTR program. Clinicians should take into account lower extremity selectivity, walking performance, and satisfaction levels as much as muscle tone or range of motion. Key Words: Botulinum Toxin; Cerebral Palsy; Parent; Physical Therapy.

Can an Observational Gait Scale Produce a Result Consistent with Symmetry Indexes Obtained from 3-Dimensional Gait Analysis?: A Concurrent Validity Study.

To investigate whether a simple observational tool may be a substitute to the time-consuming and costly 3-dimensional (3D) analysis, the study applied the Wisconsin Gait Scale (WGS), enabling assessment which is highly consistent with 3D gait parameters in patients after a stroke. The aim of this study was to determine whether, and to what extent, observational information obtained from WGS-based assessment can be applied to predict results of 3D gait analysis for selected symmetry indicators related to spatiotemporal and kinematic gait parameters. Fifty patients at a chronic stage of recovery post-stroke were enrolled in the study. The spatiotemporal and kinematic gait parameters were measured using a movement analysis system. The symmetry index (SI), was calculated for selected gait parameters. The patients’ gait was evaluated by means of the WGS. It was shown that stance % SI, as well as hip and knee flexion-extension range of motion SI can most effectively be substituted by WGS-based estimations (coefficient of determination exceeding 80%). It was shown that information acquired based on the WGS can be used to obtain results comparable to those achieved in 3D assessment for selected SIs of spatiotemporal and kinematic gait parameters. The study confirms that observation of gait using the WGS, which is an ordinal scale, is consistent with the selected aims of 3D assessment. Therefore, the scale can be used as a complementary tool in gait assessment.

Escala observacional de la marcha del sujeto con amputación de la extremidad inferior: diseño y validez de contenido

IntroductionGait pattern is altered in persons with lower extremity amputation. To assess gait pattern, it is important to use observational gait scales with a good content validity. ObjectivesTo design an observational gait scale and to analyze its content validity. Material and methodsAn expert committee was formed to obtain a version of the scale. The same committee was responsible for evaluating the scale. The content validity index (CVI) was calculated, both for each item and for the global scale. ResultsThe main kinematic and spatiotemporal alterations were selected to design the items. The scale consists of 2sections and 25 items, with a maximum score of 35 points. An overall CVI score of 0.90 was obtained, and an index of validity for most items with values higher than 0.78. ConclusionThe Observational gait scale for persons with amputation of the lower extremity showed excellent content validity according to the CVI obtained. Future studies should evaluate its reliability and construct validity.

Reliability and Minimal Detectable Change in the Gait Assessment and Intervention Tool in Patients With Multiple Sclerosis.

Gait impairment is one of the main causes of disability in people with multiple sclerosis. The Gait Assessment and Intervention Tool is an observational gait scale that assesses kinematic parameters using video recordings. To study intra- and interrater reliability and the minimal detectable change of the Gait Assessment and Intervention Tool in individuals with multiple sclerosis. Observational study. Multiple Sclerosis Foundation. Thirty-five participants with multiple sclerosis were assessed (12 men, 23 women; 47.7 ± 11 y; Expanded Disability Status Scale = 4.32 ± 1.4). Not applicable. Intra- and interrater reliability of the Gait Assessment and Intervention Tool was assessed for each limb using the Intraclass Correlation Coefficient. In addition, the minimal detectable change was calculated. The Intraclass Correlation Coefficient for the intrarater reliability was found to be excellent for the total score both for the right side (.91; 95% confidence interval 95% CI .85-.95) and the left side (.93; 95% CI .88-.96). The intraclass correlation coefficient for the interrater reliability was .91 (95% CI .85-.95) for the right side, and .93 (95% CI .88-.96) for the left side. The minimal detectable change for the intrarater reliability was 1.19 points for the right side and .77 for the left side. The Gait Assessment and Intervention Tool exhibits excellent intra- and interrater reliability and a small minimal detectable change for people with multiple sclerosis.

Efficacy of Repeat AbobotulinumtoxinA (Dysport®) Injections in Improving Gait in Children with Spastic Cerebral Palsy

ABSTRACT Purpose: This secondary analysis of a randomized, double-blind study plus open-label extension (NCT01249417/NCT01251380) evaluated the efficacy of abobotulinumtoxinA versus placebo in improving gait pattern in children with dynamic equinus due to cerebral palsy (CP) as assessed by the observational gait scale (OGS). Methods: Ambulatory children with CP (N = 241, aged 2–17) and dynamic equinus were randomized to treatment with abobotulinumtoxinA (10 or 15U/kg/leg) or placebo injected into the gastrocsoleus. All children received abobotulinumtoxinA in the open-label phase. Results: In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3], p = .0003; 15U/kg/leg: 1.1 [0.3, 1.9], p = .01). In the open-label phase, treatment with abobotulinumtoxinA continued to improve the OGS score at the same magnitude as seen in the double-blind study. Conclusion: Repeat treatment with abobotulinumtoxinA improved gait in children with dynamic equinus.

Botulinum Toxin in the Management of Children with Cerebral Palsy.

During the past 25 years, botulinum toxin type A (BoNT-A) has become the most widely used medical intervention in children with cerebral palsy. In this review we consider the gaps in our knowledge in the use of BoNT-A and reasons why muscle morphology and function in children with cerebral palsy are impaired. We review limitations in our knowledge regarding the mechanisms underlying the development of contractures and the difficulty in preventing them. It is clear from this review that injection of BoNT-A in the large muscles of both the upper and lower limbs of children with cerebral palsy will result in a predictable decrease in muscle activity, which is usually reported as a reduction in spasticity, for between 3 and 6 months. These changes are noted by the use of clinical tools such as the Modified Ashworth Scale and the Modified Tardieu Scale. Decreased muscle over-activity usually results in improved range of motion in distal joints. Injection of the gastrocnemius muscle for toe-walking in a child with hemiplegia or diplegia usually has the effect of increasing the passive range of dorsiflexion at the ankle. In our review, we found that this may result in a measurable improvement in gait by the use of observational gait scales or gait analysis, in some children. However, improvements in gait function are not always achieved and are small in magnitude and short lived. We found that some of the differences in outcomes in clinical trials may relate to the use of adjunctive interventions such as serial casting, orthoses, night splints and intensive therapy. We note that the majority of clinical trials of the use of BoNT-A in children with cerebral palsy have focussed on a single injection cycle and this is insufficient to understand the balance between benefit and harm. Most outcomes were reported in terms of changes in muscle tone and there were fewer studies with robust methodology that reported improvements in function. Changes in the domains of activities and participation have rarely been reported in studies to date. There were no clinical reviews to date that consider the findings of studies in human volunteers and in experimental animals and their relevance to clinical protocols. In this review we found that studies in human volunteers and in experimental animals show muscle atrophy after an injection of BoNT-A for at least 12 months. Muscle atrophy was accompanied by loss of contractile elements in muscle and replacement with fat and connective tissue. It is not currently known if these changes, mediated at a molecular level, are reversible. We conclude that there is a need to revise clinical protocols by using BoNT-A more thoughtfully, less frequently and with greatly enhanced monitoring of the effects on injected muscle for both short-term and long-term benefits and harms.

Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation.

To determine whether switching from onabotulinumtoxinA to abobotulinumtoxinA in children with cerebral palsy is safe and whether therapeutic efficacy is maintained. This retrospective observational study of routine care included 118 children with cerebral palsy (mean age 81.4 months (standard deviation; SD 38.9)) who had switched from onabotulinumtoxinA to abobotulinumtoxinA injections into their lower extremities due to a change in hospital policy. Analysis was limited to the final onabotulinumtoxinA treatment-cycle prior to switch, and the first abobotulinumtoxinA treatment-cycle following switch. The primary objective was to document the safety and tolerability of switching products. Efficacy endpoints included muscle tone, spasticity, and gait function based on Modified Ashworth Scale (MAS), Tardieu Scale (TS) and Observational Gait Scale (OGS) scores. Treatment-emergent adverse events were recorded in 41 (34.7%) and 31 (26.3%) patients during the onabotulinumtoxinA and abobotulinumtoxinA treatment cycles, respectively. Treatment-related adverse events were reported in 5 patients in the onabotulinumtoxinA treatment-cycle vs 7 in the abobotulinumtoxinA treatment-cycle (p?=?0.774). Treatment efficacy (4–6 weeks post-treatment) was similar in the onabotulinumtoxinA and abobotulinumtoxinA treatment-cycles for all variables (MAS, TS, OGS). In children with cerebral palsy, switching from onabotulinumtoxinA to abobotulinumtoxinA is safe and generally well-tolerated and therapeutic efficacy is maintained.

Switching from onabotulinumtoxinA to abobotulinumtoxinA in children with cerebral palsy treated for spasticity: A retrospective safety evaluation

Botulinum neurotoxin-A (BoNT-A) is an important treatment in the management of hypertonia in children with cerebral palsy (CP). To date, there are no controlled head-to-head clinical trials comparing the efficacy and safety of different BoNT-A formulations in CP. The main aims of this study were to explore whether switching from onabotulinumtoxinA (OnaBoNT-A) to abobotulinumtoxinA (AboBoNT-A) is safe and whether therapeutic efficacy is maintained. This retrospective observational study included 118 children with CP (mean age: 81.4 ± 38.9 months) who had switched from OnaBoNT-A to AboBoNT-A injections into their lower extremities due to a change in hospital policy. Analysis was limited to the final OnaBoNT-A treatment cycle (TC) prior to switch, and the first AboBoNT-A TC following switch. The primary objective was to document safety in children switched from OnaBoNT-A to AboBoNT-A. Efficacy endpoints included muscle tone, spasticity, and gait function based on Modified Ashworth Scale (MAS), Tardieu Scale (TS), and Observational Gait Scale (OGS) scores. A sub-analysis was performed to investigate the time to retreatment for patients attending their follow-up visits for efficacy assessments ( n = 52). Treatment emergent adverse events were recorded in 41 (34.7%) and 31 (26.3%) patients during the OnaBoNT-A and AboBoNT-A TCs, respectively. Treatment related adverse events were reported in 5 patients in OnaBoNT-A TC versus 7 in AboBoNT-A ( P = 0.774). Treatment efficacy, (4–6 weeks post-treatment) was found to be similar in the OnaBoNT-A and AboBoNT-A TCs for all variables (MAS, TS, OGS). The sub-analysis of 52 patients revealed a significantly longer retreatment interval with AboBoNT-A (27.6 ± 11.8 weeks) versus OnaBoNT-A (23.3 ± 8.7 weeks) ( P = 0.004). In children with CP, switching from OnaBoNT-A to AboBoNT-A was safe and efficacy was maintained. In a subgroup analysis AboBoNT-A appeared to have a longer retreatment interval than OnaBoNT-A.