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 .

Reproducibility of Task-Oriented Bimanual and Unimanual Strength Measurement in Children with Unilateral Cerebral Palsy.

Aim: To examine reproducibility of the arm-hand strength measured while performing the bimanual crate task and the unimanual pitcher task. Methods: 105 children diagnosed with unilateral Cerebral Palsy, aged between 6 and 18 years, participated in this study. The test-retest reliability of the force generated during bimanual crate task and unimanual pitcher task of the Task-oriented Arm-hAnd Capacity instrument was investigated using intraclass correlation two-way random model with absolute agreement. The intraclass correlations were calculated for two age groups (6-12 and 13-18 years old). Results: The results showed good test-retest reliability for the crate and pitcher task with the non-affected hand for both age groups. The results of the pitcher task for the affected hand showed moderate test-retest reliability for both age groups. Conclusion: The Task-oriented Arm-hAnd Capacity instrument has moderate to good test-retest reliability. It is a simple and objective instrument to assess task-oriented strength in children with unilateral cerebral palsy.

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.

Cross-cultural Translation and Adaptation of the Lifestyle Assessment Questionnaire (LAQ-CP) Into Dutch: A Brief Report.

PURPOSE: To produce a Dutch translation of the Lifestyle Assessment Questionnaire for children with cerebral palsy (LAQ-CP), adapted for cross-cultural differences. METHODS: The translation process consisted of 6 stages, following a guideline for cross-cultural adaptations including duplicate forward- and back-translations, expert group review, pilot-testing, and a process audit. RESULTS: Several adaptations to the questionnaire were required due to cross-cultural differences. As a result of the pilot-test, the layout was adapted to the desires of the users. The process auditor stated that the process had been comprehensive and valued the quality of the work. CONCLUSION: The project resulted in a Dutch translation of the LAQ-CP, adapted for cross-cultural differences. Validation of the translated questionnaire is required before use in clinical practice and research is recommended (Dutch abstract, Supplemental Digital Content 1, available at: http://links.lww.com/PPT/A164).

Effects of botulinum toxin A and/or bimanual task-oriented therapy on upper extremity activities in unilateral Cerebral Palsy: a clinical trial.

BACKGROUND: This study reports on the effects of botulinum toxin A (BoNT-A) injections in the upper extremity (UE) in children with unilateral Cerebral Palsy (uCP) combined with bimanual task-oriented therapy (BITT) or either treatment modality performed separately. Bimanual activities were measured with the Assisting Hand Assessment (AHA), the ABILHand-Kids questionnaire (AK), the Observational Skills Assessment Score (OSAS). Goal achievement was measured with Goal Attainment Scaling (GAS), using blind video assessment, and the Canadian Occupational Performance Measure (COPM). METHODS: Thirty-five children, mean age 7.14 years (SD 2.63), 11 Manual Ability Classification Score (MACS) I, 15 MACS II and 9 MACS III, participated. The trial started with four study groups: BoNT-A-only (n = 5), BITT-only (n = 11), BoNT-A + BITT (n = 13), and control (n = 6). Twenty-two children were randomised, 13 children received their parents' preferred treatment: BoNT-A + BITT or BITT-only. Three comparisons were analysed: BITT (BoNT-A + BITT and BITT-only; n = 24) versus no BITT (BoNT-A-only and control; n = 11), BoNT-A (BoNT-A-only and BoNT-A + BITT; n = 18) versus no BoNT-A (BITT-only and control; n = 17), and the additional effect of BoNT-A (BoNT-A + BITT versus BITT-only). Follow-up time: 24 weeks. RESULTS: No significant differences between the groups were found on the AHA. The amount of use of both hands on the OSAS was significantly better in the BoNT-A group in the beading and sandwich-making task. The BoNT-A group also showed significant improvement in the quality scores of the OSAS: the wrist position during grasping and holding, especially in the younger children. The BITT group improved significantly on the AK and significantly more on the performance and satisfaction scores of the COPM at 12 and 24 weeks regarding several goals. BoNT-A showed a significant negative effect at 12 and 24 weeks in the most important goal. BITT, more than BoNT-A + BITT, showed positive effects on the GAS score at 12 (significant), 18 and 24 weeks. CONCLUSIONS: BoNT-A has a positive effect on quality of movement and amount of use of the affected UE during the 3 months' working time. BoNT-A has no additional effect on bimanual performance and goal achievement. BITT has a positive effect on goal achievement and bimanual performance, even up to 6 weeks after therapy had stopped. TRIAL REGISTRATION: Current Controlled Trials ISRCTN69541857.

Observational skills assessment score: reliability in measuring amount and quality of use of the affected hand in unilateral cerebral palsy.

BACKGROUND: The Observational Skills Assessment Score (OSAS) measures amount and quality of use of the affected hand in children with unilateral Cerebral Palsy (CP) in bimanual activities and could therefore be a valuable addition to existing assessment tools. The OSAS consists of tasks that are age appropriate and require use of the affected hand. METHODS: To measure the agreement and reliability of the OSAS a convenience sample of two groups of 16 children with unilateral spastic CP (2.5-6 and 12-16 years old), performed age specific bimanual tasks in 2 measurement sessions. Three experienced raters took part in testing and 8 in scoring. Intra class correlation (ICC) values for intra- and inter-rater reliability, and the mean and standard deviation of the differences between measurements were calculated. For test-retest reliability beside ICC scores, Smallest Detectable Differences (SDDs) were calculated in 16 older and 10 younger children. RESULTS: Generally, there seems to be good agreement between repeated measurements of the OSAS, as indicated by the small SDDs on most scales for quality of movement, compared to the range of their scales. This indicates potentially good sensitivity to change if used for patient evaluation purposes. The exceptions were the 'quality of reach' score for all tasks, and all quality scores for the stacking blocks task for the young children. As used in the present study, the OSAS has good discriminative capacity within patient populations as indicated by the high ICCs for most quality scores. Measuring the amount of use does not seem to be useful for either discrimination or evaluation. CONCLUSION: In general, the OSAS seems to be a reliable tool for assessing the quality of use of the affected hand in bimanual activities in younger and older children with unilateral CP. Some modifications may improve its usefulness and efficiency.

Reliability of maximum isometric arm, grip and pinch strength measurements in children (7-12 years) with unilateral spastic cerebral palsy.

Purpose: To investigate test-retest and inter-rater reliability of maximum isometric arm muscle strength measurements using the hand-held dynamometer (HDD) and maximum isometric grip and pinch strength measurements using the Biometrics E-Link Evaluation System in children aged 7-12 years with unilateral spastic cerebral palsy.Materials and methods: All data were obtained using a test-retest study design. The study met the conditions of the COSMIN criteria to achieve good methodological quality.Results: For arm strength measurements, all test-retest reliability intraclass correlation coefficient (ICC) values and all but one inter-rater reliability ICC value indicated excellent reliability. For grip- and pinch strength measurements, all test-retest reliability and inter-rater reliability ICC values showed excellent reliability. The standard error of measurement values ranged from 4.97 to 11.36 N (HDD) and 0.37 to 1.81 kg (E-link). Smallest detectable change values ranged from 13.79 to 31.49 N (HDD) and 1.03 to 5.02 kg (E-link).Conclusions: The HDD and E-link system are usable measurement instruments for cross-sectional muscle strength measurements in children with unilateral spastic cerebral palsy. It is not clear if both instruments are usable to measure changes in muscle strength within an individual, especially if a child with unilateral spastic cerebral palsy has low muscle strength. Caution in the interpretation of changes in muscle strength is therefore necessary.Implications for RehabilitationThe hand-held dynamometer and E-Link Evaluation System are reliable measurement instruments to measure muscle strength of the arm and hand in children with unilateral spastic cerebral palsy, aged 7-12 years.Cross-sectional measurements; it is possible to measure upper extremity muscle strength in children with unilateral spastic cerebral palsy with the hand-held dynamometer and E-link system.Longitudinal measurements; changes in upper extremity muscle strength within one person should be interpreted with care, especially if a child with unilateral spastic cerebral palsy has low muscle strength.

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.

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.

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.

Effects of botulinum toxin A and/or bimanual task-oriented therapy on upper extremity impairments in unilateral Cerebral Palsy: an explorative study.

OBJECTIVE: This study reports on the effects of botulinum toxin A (BoNT-A) injections in the upper extremity (UE) of children with unilateral Cerebral Palsy (uCP) combined with bimanual task oriented therapy (BITT) or either treatment modality performed separately on UE range of motion (ROM), spasticity and (functional) strength. METHODS: Thirty-five children, mean age 7.14 years (SD 2.63) of whom 11 had a Manual Ability Classification Score (MACS) I, 15 MACS II and 9 MACS III, participated. The trial started with four study groups: BoNT-A-only (n = 5), BITT-only (n = 11), BoNT-A + BITT (n = 13), and control (n = 6). Twenty-two children were randomized and, due to recruitment problems 13 children received their parents' preferred treatment: BoNT-A + BITT or BITT-only. Three comparisons were analysed: BITT (BoNT-A + BITT and BITT-only; n = 24) versus no BITT (BoNT-A-only and control; n = 11), BoNT-A (BoNT-A-only and BoNT-A + BITT; n = 18) versus no BoNT-A (BITT-only and control; n = 17), and the additional effect of BoNT-A (BoNT-A + BITT versus BITT-only). RESULTS: BoNT-A significantly decreased key grip strength and finger flexion tone, had a clinically relevant (additional) positive effect on active thumb abduction and supination and a significantly negative effect on unilateral functional strength. BITT + BoNT-A significantly increased active supination. BITT reduced elbow flexor tone and BITT-only resulted in more improvement than BoNT-A + BITT in functional unimanual and, to a lesser extent, in bimanual grip strength. CONCLUSIONS: In comparison with BoNT-A + BITT, BITT-only gives more improvement on functional grip strength and, therefore, could possibly increase bimanual performance. In this case, the (additional) role of BoNT-A may be an increase in active supination and thumb abduction.

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.

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.

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.