Functional electrical stimulation during walking in children with unilateral spastic cerebral palsy: A randomized cross-over trial.

AIM: To study if functional electrical stimulation (FES) of the peroneal nerve, which activates dorsiflexion, can improve body functions, activities, and participation and could be an effective alternative treatment in individuals with unilateral spastic cerebral palsy (CP). METHOD: A randomized cross-over trial was performed in 25 children with unilateral spastic CP (classified in Gross Motor Function Classification System levels I and II) aged 4 to 18 years (median age at inclusion 9 years 8 months, interquartile range = 7 years-13 years 8 months), 15 patients were male. The study consisted of two 12-week blocks of treatment, that is, conventional treatment (ankle foot orthosis [AFO] or adapted shoes) and FES, separated by a 6-week washout period. Outcome measures included the Goal Attainment Scale (GAS), the Cerebral Palsy Quality of Life questionnaire, and a three-dimensional gait analysis. RESULTS: Eighteen patients completed the trial. The proportion of GAS goals achieved was not significantly higher in the FES versus the conventional treatment phase (goal 1 p = 0.065; goal 2 p = 1.00). When walking while stimulated with FES, ankle dorsiflexion during mid-swing decreased over time (p = 0.006, average decrease of 4.8° with FES), with a preserved increased ankle range of motion compared to conventional treatment (p < 0.001, mean range of motion with FES +10.1° compared to AFO). No changes were found in the standard physical examination or regarding satisfaction with orthoses and feelings about the ability to dress yourself. In four patients, FES therapy failed; in 12 patients FES therapy continued after the trial. INTERPRETATION: FES is not significantly worse than AFO; however, patient selection is critical, and a testing period and thorough follow-up are needed.

A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial.

BACKGROUND: Spastic cerebral palsy is the most common cause of motor disability in children. It often leads to foot drop or equinus, interfering with walking. Ankle-foot orthoses (AFOs) are commonly used in these cases. However, AFOs can be too restrictive for mildly impaired patients. Functional electrical stimulation (FES) of the ankle-dorsiflexors is an alternative treatment as it could function as a dynamic functional orthosis. Despite previous research, high level evidence on the effects of FES on activities and participation in daily life is missing. The primary aim of this study is to evaluate whether FES improves the activity and participation level in daily life according to patients, and the secondary aim is to provide evidence of the effect of FES at the level of body functions and activities. Furthermore, we aim to collect relevant information for decisions on its clinical implementation. METHODS: A randomized crossover trial will be performed on 25 children with unilateral spastic cerebral palsy. Patients aged between 4 and 18 years, with Gross Motor Functioning Classification System level I or II and unilateral foot drop of central origin, currently treated with AFO or adapted shoes, will be included. All participants will undergo twelve weeks of conventional treatment (AFO/adapted shoes) and 12 weeks of FES treatment, separated by a six-week washout-phase. FES treatment consists of wearing the WalkAide® device, with surface electrodes stimulating the peroneal nerve during swing phase of gait. For the primary objective, the Goal Attainment Scale is used to test whether FES improves activities and participation in daily life. The secondary objective is to prove whether FES is effective at the level of body functions and structures, and activities, including ankle kinematics and kinetics measured during 3D-gait analysis and questionnaire-based frequency of falling. The tertiary objective is to collect relevant information for clinical implementation, including acceptability using the device log file and side effect registration, cost-effectiveness based on quality adjusted life years (QALYs) and clinical characteristics for patient selection. DISCUSSION: We anticipate that the results of this study will allow evidence-based use of FES during walking in children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03440632 .

Upper Extremity Muscle Strength in Children With Unilateral Spastic Cerebral Palsy: A Bilateral Problem?

OBJECTIVE: The objective was to investigate whether muscle strength in the nonaffected and affected upper extremities (UEs) in children (7-12 years) with unilateral spastic cerebral palsy (USCP) differs from that in children with typical development (TD). METHODS: A cross-sectional study design was used. Isometric arm strength (wrist flexion, wrist extension with flexed and extended fingers, elbow flexion/extension) was assessed in 72 children (mean age = 9.3 [SD = 1.9] years) with USCP, and isometric grip/pinch strength was assessed in 86 children (mean age = 9.3 [SD = 1.8] years) with USCP. Arm/grip/pinch strength was assessed in 120 children (mean age = 9.5 [SD = 1.7] years) with TD. Arm strength was measured with a hand-held dynamometer, and grip/pinch strength was measured with a calibrated, modified (digitized) grip dynamometer and a pinch meter. The nonaffected UE of children with USCP was compared with the preferred UE of children with TD because both sides represent the preferred UE. The affected UE was compared with the nonpreferred UE of children with TD, as both sides represent the nonpreferred UE. RESULTS: In all measurements except for grip strength of the preferred UE, children with USCP were weaker than children with TD. CONCLUSIONS: In children with USCP, muscle strength weakness exists in both UEs. IMPACT: When unimanual or bimanual ability limitations are present in children with unilateral cerebral palsy, investigation of the muscle strength of the nonaffected UE should be part of the assessment.

Psychometric Evaluation of 2 New Upper Extremity Functional Strength Tests in Children With Cerebral Palsy.

BACKGROUND: For children with unilateral spastic cerebral palsy (USCP), reduced muscle strength can lead to activity limitations. However, none of the existing measures of upper extremity strength measure strength in the context of functional activities in which strength must be maintained for several seconds. OBJECTIVE: The objective of this study was to evaluate the psychometric properties of 2 newly developed functional hand and upper extremity muscle-strength tests (Cup-Task and Box-Task) in children aged 7 to 12 years with USCP. DESIGN: A longitudinal study design was used. METHODS: A standardized protocol with detailed descriptions of all procedures and measurements was used to determine test-retest reliability, interrater reliability, and criterion validity. RESULTS: A total of 86 children (53 males, 33 females, mean age = 9.3 years) with USCP participated in this study, with a subset performing each measurement. Only the results of children who were able to perform the measurement were included for analysis. Excellent test-retest reliability (intraclass correlation coefficients = 0.887-0.944; 95% confidence intervals = 0.713-0.969) and interrater reliability (intraclass correlation coefficients = 0.896-0.960; 95% confidence intervals = 0.813-0.980) were observed. The Cup-Task Affected-Hand and Box-Task were moderately correlated with maximum isometric grip strength. The Cup-Task Nonaffected-Hand had a low correlation with maximum isometric grip strength. LIMITATIONS: Age, sex, and manual ability were not normally distributed, which could have influenced the results. CONCLUSIONS: For children with USCP who can perform the tasks, the Cup-Task and Box-Task are reliable and valid instruments for measuring functional upper extremity muscle strength.

Functional electrical stimulation of the ankle dorsiflexors during walking in spastic cerebral palsy: a systematic review.

AIM: To assess the effect of functional electrical stimulation (FES) of ankle dorsiflexors in children and adolescents with spastic cerebral palsy (CP) during walking. METHOD: A systematic review was performed using the American Academy of Cerebral Palsy and Developmental Medicine methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Six databases were searched for studies applying interventions to patients aged younger than 20 years. Outcomes were classified according to the International Classification of Functioning, Disability and Health (ICF). RESULTS: Seven hundred and eighty abstracts were found, 35 articles were fully screened, and 14 articles were used for analysis. Only five articles (three studies) were of level I to III evidence. At ICF participation and activity level, there is limited evidence for a decrease in self-reported frequency of toe-drag and falls. At ICF body structure and function level, there is clear evidence (I-III) that FES increased (active) ankle dorsiflexion angle, strength, and improved selective motor control, balance, and gait kinematics, but decreased walking speed. Adverse events include skin irritation, toleration, and acceptation issues. INTERPRETATION: There are insufficient data supporting functional gain by FES on activity and participation level. However, evidence points towards a role for FES as an alternative to orthoses in children with spastic CP. WHAT THIS PAPER ADDS: Effects of functional electrical stimulation (FES) point towards a potential role as an alternative to orthoses for patients with spastic cerebral palsy (CP). Some evidence for a decrease in self-reported frequency of toe-drag and falls with the use of FES in spastic CP. Limited evidence for improvements in activity and participation in patients with spastic CP using FES.

Effect of addition of botulinum toxin-A to standardized therapy for dynamic manual skills measured with kinematic aiming tasks in children with spastic hemiplegia.

OBJECTIVE: To measure the effect of intensive therapy and the lasting effect of a standardized functional training programme with vs. without the addition of chemodernervation of the muscles of the forearm and hand. PATIENTS AND METHODS: Twenty children with spastic hemiplegia, aged 4-16 years, were matched for baseline characteristics and randomized to standardized task-oriented therapy for 6 months with or without botulinum toxin injections. Dynamic kinematic outcome measures were: speed, accuracy, end-point spread and performance. Measurements of active and passive range of motion, stretch-restricted angle of the elbow and wrist, Ashworth scores and Melbourne Assessment of Unilateral Upper Limb Function were made. All measures were performed at baseline, 2 weeks after injection of botulinum toxin and after 6 months (at the end of therapy), and 3 months after end of the therapy. RESULTS: Clinical measures showed improvement in both groups. However, no significant differences emerged between groups on functional measures. Directly after the botulinum toxin injection all kinematic outcome measures showed a decrease, but baseline values were re-established during the therapy period. After botulinum toxin injections a temporarily significant greater increase in speed and performance was found. These results illustrate the need for further quantitative research into the effects of botulinum toxin.

Visual Analogue Scale to score the effects of Botulinum Toxin A treatment in children with cerebral palsy in daily clinical practice.

OBJECTIVE: This study examined the reliability and efficiacy of the Visual Analogue Scale (VAS) in evaluating spasticity treatment in an outpatient setting. PATIENTS AND METHODS: We used a parent-reported VAS device for evaluating the effects of Botulinum Toxin A (BTX-A). Data were collected on 55 children with cerebral palsy. Individual goals of treatment were formulated in close consultation with the caregivers. The categories of treatment options were improvement of pain, problems with nursing, sitting position, standing and walking. RESULTS: Seventy-four interventions were performed in 55 children. A statistically significant effect was found for improvement of nursing, standing and walking. No statistically significant effect for pain was found, probably because of small numbers. In seven children there was no effect at all. Side effects were observed in five children. CONCLUSION: In using a VAS instrument, beneficial effects were found for nursing, standing and walking after BTX-A treatment. A positive (not significant) correlation was found between the VAS and the Modified Tardieu for those children who also underwent a gait analysis. Evaluating spasticity treatment with the use of the VAS has an important advantage because it is a quick and easy method for evaluating individually defined treatment goals in an outpatient setting, in which time-consuming evaluations are not an option.

Kinematic aiming task: measuring functional changes in hand and arm movements after botulinum toxin-A injections in children with spastic hemiplegia.

OBJECTIVE: To describe different aspects of a kinematic aiming task (KAT) as a quantitative way to assess changes in arm movements within 2 wks after botulinum toxin-A (BTX-A) injections in children with spastic hemiplegia. DESIGN: Intervention study randomized clinical trial; follow-up within 4 wks after baseline measurement. RESULTS: The KAT gave a high intraclass correlation on movement time, spread of end points (END), and index of performance effective (IP-E). After BTX-A, a significant increase of END and IP-E was shown if precision demand in the KAT was high, whereas the inverse occurred when speed was more important. These functional changes coincided with a significant decrease of the maximum voluntary contraction of the flexor muscles of the forearm. Muscle tone measured with the Ashworth scale did show a nonsignificant decrease of muscle tone, as did the stretch restricted angle and the active and passive ranges of motion of the elbow and wrist. CONCLUSIONS: Muscle force decreased immediately after BTX-A, showing the direct effect of BTX-A. The KAT is an adequate, reproducible way to quantify functional changes after BTX-A in the upper limb. BTX-A has an inverse effect in the precision task when accuracy is important, and it has a positive effect when speed prevails.

Effect of multilevel botulinum toxin a and comprehensive rehabilitation on gait in cerebral palsy.

To evaluate the effect of multilevel botulinum toxin A and comprehensive rehabilitation on gait pattern, muscle length, and spasticity, a multicenter randomized trial was performed in 46 children with spastic cerebral palsy who walk with flexed knees. Their mean age was 8.0 years (range 4 to 11 years). They were randomly allocated to the intervention group (multilevel botulinum toxin A and comprehensive rehabilitation) or the control group (usual care). After 6 weeks, a significant treatment effect in the intervention group was observed on: improved knee extension during midstance and terminal swing (7 degrees and 5 degrees , P < 0.01, respectively); hip rotation during terminal swing (4 degrees , P = 0.02); gait score (1.7, P < 0.01); decreased spasticity in hamstrings (11 degrees , P < 0.01), gastrocnemius (6 degrees , P = 0.01), and soleus (5 degrees , P = 0.02); and increased muscle length in hamstrings (9 degrees , P < 0.01) and gastrocnemius (5 degrees , P < 0.01). The improved muscle length was maintained up to 24 weeks. This study demonstrated that multilevel botulinum toxin A and comprehensive rehabilitation improves knee extension during gait, increases muscle length, and decreases spasticity in injected muscles after 6 weeks in children who walk with flexed knees. Although the effect on muscle length was maintained after 24 weeks, the effect on gait and spasticity had disappeared.

The combined effect of lower-limb multilevel botulinum toxin type a and comprehensive rehabilitation on mobility in children with cerebral palsy: a randomized clinical trial.

OBJECTIVE: To evaluate the combined effect on mobility of treatment with multilevel botulinum toxin type A (BTX-A) and comprehensive rehabilitation in children with cerebral palsy (CP). DESIGN: Randomized clinical trial using a multiple baseline design. The intervention group was treated 6 weeks after randomization. The control group was treated after a longer period of 18 to 30 weeks. Repeated measurements in both groups were continued throughout the process, before and up to 48 weeks after treatment. SETTING: Four departments of rehabilitation medicine in The Netherlands. PARTICIPANTS: Forty-six children with spastic CP (mean age +/- standard deviation, 8.0+/-2.1y). INTERVENTION: The intervention group (n=23) was treated with multilevel BTX-A and comprehensive rehabilitation. Control group subjects (n=23) continued with their usual physical therapy (PT) for 18 to 30 weeks, and then also received multilevel BTX-A and comprehensive rehabilitation. MAIN OUTCOME MEASURES: The primary outcome measure was the Gross Motor Function Measure (GMFM-66); the secondary measures were problem score and energy cost. RESULTS: The treatment effect during the first 24 weeks of follow-up in the intervention group was compared with the effect of usual PT in the control group. Treatment with multilevel BTX-A and comprehensive rehabilitation provided a significantly greater improvement at 12 and 24 weeks in both the GMFM-66 (2.1 points, P=.02; and 3.5 points, P<.01, respectively) and problem score (1.8 and 1.7 points, P<.001, respectively) compared with usual PT. No difference was found in energy cost. Before-after analysis of the total group (n=46) showed a significant long-term improvement (48wk) on all outcome measures. CONCLUSIONS: Treatment with multilevel BTX-A and comprehensive rehabilitation significantly improves mobility as measured by the GMFM-66 and problem score in children with CP.