Feasibility of At-Home Hand Arm Bimanual Intensive Training in Virtual Reality: Case Study.

This single-participant case study examines the feasibility of using custom virtual reality (VR) gaming software in the home environment for low-dose Hand Arm Bimanual Intensive Training (HABIT). A 10-year-old with right unilateral cerebral palsy participated in this trial. Fine and gross motor skills as well as personal goals for motor outcomes were assessed before and after the intervention using the Box and Blocks Test, Nine-Hole Peg Test, and Canadian Occupational Performance Measure. Movement intensities collected via the VR hardware accelerometers, VR game scores, and task accuracy were recorded via the HABIT-VR software as indices of motor performance. The child and family were instructed to use the HABIT-VR games twice daily for 30 minutes over a 14-day period and asked to record when they used the system. The child used the system and completed the 14-hour, low-dose HABIT-VR intervention across 22 days. There was no change in Box and Blocks Test and Nine-Hole Peg Test scores before and after the intervention. Canadian Occupational Performance Measure scores increased but did not reach the clinically relevant threshold, due to high scores at baseline. Changes in motor task intensities during the use of VR and mastery of the VR bimanual tasks suggested improved motor efficiency. This case study provides preliminary evidence that HABIT-VR is useful for promoting adherence to HABIT activities and for the maintenance of upper extremity motor skills in the home setting.

Benefits of inspiratory muscle training therapy in institutionalized adult people with cerebral palsy: A double-blind randomized controlled trial.

BACKGROUND: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with cerebral palsy (CP). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with inspiratory muscle training (IMT), low intensity and high intensity, to improve respiratory strength and pulmonary function in adults with CP. METHODS: The study was a controlled, randomized, double-blind trial with allocation concealment. Twenty-seven institutionalized CP patients were recruited and randomly distributed in the high-intensity training group (HIT) or low-intensity training group (LIT). Over 8 weeks, an IMT protocol was followed 5 days/week, 10 series of 1 min with 1 min rest between them. HIT trained with a load of 40% of the maximum inspiratory pressure (MIP) and LIT with 20%. Respiratory strength and pulmonary function were evaluated. RESULTS: After IMT intervention, MIP, maximum expiratory pressure, forced expiratory volume in 1 s (FEV1) and peak expiratory flow increased in both groups; in HIT 29%, 19%, 13%, and 8%, respectively (p = 0.000, p = 0.000, p = 0.002, p = 0.001) and in LIT 17%, 7%, 3%, and 4%, respectively (p = 0.000, p = 0.000, p = 0.049, p = 0.113). All the improvements were significantly higher in HIT than in LIT. CONCLUSION: Inspiratory muscle training improved respiratory muscle strength and pulmonary function in adults with CP. Training with a 40% MIP load improved all the evaluated parameters and was the most effective treatment for adults with CP.

Feasibility of a home-based home videogaming intervention with a family-centered approach for children with cerebral palsy: a randomized multiple baseline single-case experimental design.

BACKGROUND: Worldwide, children with cerebral palsy (CP) living in underserved communities face barriers to accessing motor therapy services. This study assessed the implementation and effectiveness of an 8-week, upper limb (UL) home-based intervention with a movement-tracking videogame (Bootle Blast) in Costa Rican children with CP. METHODS: Children established a weekly playtime goal and two UL activities of daily living (ADLs) that they would like to improve on. A multiple-baseline, single-case experimental design, was used with the Performance Quality Rating Scale (PQRS) as the repeated measure to track changes in performance of the selected ADLs between the baseline (usual care) and intervention (Bootle Blast) phases. The Canadian Occupational Performance Measure (COPM), the Box and Blocks Test (BBT) and the Children's Hand-Use Experience Questionnaire (CHEQ) were collected before and after the intervention. Technical barriers were documented during weekly video calls with a monitoring therapist. Treatment effect size, slope changes and percentage of non-overlapping data were identified for the PQRS. Descriptive statistics summarized results for the BBT, CHEQ, videogame logs (e.g., playtime) and technical barriers. RESULTS: Fifteen children participated and 13 completed the intervention. Both participants who dropped out did so after completing baseline assessments, but before experiencing Bootle Blast. Children's mean active playtime (i.e., mini-games targeting the UL) across the 8-weeks was 377 min, while mean total time spent engaging with Bootle Blast (active + passive play time [e.g., time navigating menus, reviewing rewards]) was 728 min. In total, eight technical issues (from five children) were reported, and all but three were resolved within 48 h. Partial effectiveness was associated with the intervention. Specifically, 85% of participants improved on the PQRS and 69% achieved clinically important improvements ≥ 2 points in performance on the COPM. Children improved by 1.8 blocks on average on the BBT, while on the CHEQ, five children had a clinically important increase of 10% of the total number of UL activities performed with both hands. CONCLUSION: Bootle Blast is a feasible and effective option to facilitate access and engage children with cerebral palsy in UL home rehabilitation. Trial registration Trial registration number: NCT05403567.

Effect of a Rehabilitation Program Including Home-Based Vibration-Assisted Therapy on Gait Parameters in Children with Cerebral Palsy.

OBJECTIVES: The aim of the present study was to examine the effects of a rehabilitation program combined with a home-based vibration-assisted therapy on gait parameters in children with cerebral palsy (CP). METHODS: In a retrospective study, 180 children, 101 boys and 79 girls, (mean age 7.2 ± 3.3 years) with CP at Gross Motor Function Classification System (GMFCS) Level I and Level II were examined using gait analyses with the Leonardo Mechanograph® Gangway at three measurement points. The measurements were conducted before (M0) and after a six-month rehabilitation period (M6), as well as 12 months after the commencement of rehabilitation (M12). The difference between measurement points M6-M0 (treatment interval) and M12-M6 (follow-up interval) were compared, and significance was determined using the Wilcoxon test. RESULTS: Children with CP at GMFCS Level I and II demonstrated a significant improvement in gait efficiency (pathlength/distance M6-M0: -0.053 (SD 0.25) vs M12-M6: -0.008 (0.36), p=0.038). There were no significant difference in change of mean velocity and average step length between M6-M0 and M12-M6 (p=0.964 and p=0.611). CONCLUSIONS: The rehabilitation program seems to enhance gait efficiency in children with CP. German Clinical Trial Registry: DRKS0001131 at www.germanctr.de.

Effect of touch screen tablet use on fine motor functions in children with hemiparetic cerebral palsy: A randomized controlled trial.

BACKGROUND: Cerebral palsy is the most frequent condition affecting the central nervous system and causing large disability. OBJECTIVE: To determine the impact of touch screen tablet upon fine motor functions in children with hemiparesis. METHOD: This was a randomized controlled trial involving 60 children, ranging in age from 5 to 7 years old, randomized into two groups: intervention or control group (30 children per group). Both groups were given 12 consecutive weeks of designed fine motor tasks. Additionally, for thirty minutes, the intervention group was given a fine motor exercise program on a touch screen tablet. Upper limb function, finger dexterity and pinch strength were measured pre and post the recommended treatment program using the quality of upper extremity skill test (QUEST), Nine-Hole Peg Test and Jamar hydraulic pinch gauge, respectively. RESULTS: All outcome measures were equivalent between intervention groups at admission (P > 0.05). Significant improvements were found in all assessed variables within the two groups. Meanwhile, the intervention group had significantly higher improvements (P < 0.05) in finger dexterity, pinch strength, and upper limb function when compared with the control groups. CONCLUSION: Including a touch screen smart tablet application with a specially designed fine motor program is an effective method that helps children with U-CP perform more effectively with their fine motor skills.

Effect of robotic-assisted gait training program on spatiotemporal gait parameters for ambulatory children with cerebral palsy: A randomized control trial.

BACKGROUND: Gait training programs are commonly used to improve gait in children with cerebral palsy (CP). OBJECTIVE: To compared the effects of robotic-gait assistant training (RAGT) and conventional body weight support treadmill training (CBWSTT) on gait parameters among ambulatory children with CP. METHODS: The study is a randomized controlled trial of 36 children (17 in the RAGT group and 19 in the CBWSTT group) aged 5 to 14. Gait training involved 30-to 35-minute sessions three times per week over eight weeks. RESULTS: Mixed ANCOVA showed no main effect of time or group on all gait parameters (P > .05). Gross motor function measure dimensions D (GMFM D) and E (GMFM E) show main effects on step width. Stride length, step length, speed, swing phase, and double support phase interacted with GMFM D and E. There was a negative correlation between motor function level and the change from baseline. Children with lower motor function show a greater change from baseline. CONCLUSION: There were no significant differences between CBWSTT and RAGT for children with CP; however, with gait training interventions, the level of motor function should be considered.

Early intensive rehabilitation reverses locomotor disruption, decrease brain inflammation and induces neuroplasticity following experimental Cerebral Palsy.

BACKGROUND: Cerebral Palsy (CP) is a major cause of motor and cognitive disability in children due to injury to the developing brain. Early intensive sensorimotor rehabilitation has been shown to change brain structure and reduce CP symptoms severity. We combined environmental enrichment (EE) and treadmill training (TT) to observe the effects of a one-week program of sensorimotor stimulation (EETT) in animals exposed to a CP model and explored possible mechanisms involved in the functional recovery. METHODS: Pregnant Wistar rats were injected with Lipopolysaccharide (LPS - 200 µg/kg) intraperitoneally at embryonic days 18 and 19. At P0, pups of both sexes were exposed to 20' anoxia at 37 °C. From P2 to P21, hindlimbs were restricted for 16 h/day during the dark cycle. EETT lasted from P21 to P27. TT - 15 min/day at 7 cm/s. EE - 7 days in enriched cages with sensorimotor stimulus. Functional 3D kinematic gait analysis and locomotion were analyzed. At P28, brains were collected for ex-vivo MRI and histological assessment. Neurotrophins and key proteins involved in CNS function were assessed by western blotting. RESULTS: CP model caused gross and skilled locomotor disruption and altered CNS neurochemistry. EETT reversed locomotor dysfunction with minor effects over gait kinematics. EETT also decreased brain inflammation and glial activation, preserved myelination, upregulated BDNF signaling and modulated the expression of proteins involved in excitatory synaptic function in the brain and spinal cord. CONCLUSIONS: Using this translational approach based on intensive sensorimotor rehabilitation, we highlight pathways engaged in the early developmental processes improving neurological recovery observed in CP.

Comparing the effectiveness of robotic plantarflexion resistance and biofeedback between overground and treadmill walking.

Individuals with diminished walking performance caused by neuromuscular impairments often lack plantar flexion muscle activity. Robotic devices have been developed to address these issues and increase walking performance. While these devices have shown promise in their ability to increase musculature engagement of the lower limbs when used on a treadmill, most have not been developed or validated for overground walking and community use. Overground walking may limit the effectiveness of robotic devices due to differences in gait characteristics between walking terrains and reduced user engagement. The purpose of this study was to validate our multimodal robotic gait training system for overground walking in individuals with neuromuscular gait impairments. This untethered wearable robotic device can provide an ankle resistive torque proportional to the users' biological ankle torque. The device can also provide audio biofeedback based on users' plantar pressure intending to increase ankle power and muscle activity of the plantar flexors. Seven individuals with cerebral palsy participated. Participants walked overground and on a treadmill with our robotic gait training system in a single testing session. Results showed all seven participants to increase peak plantar flexor muscle activity, 10.3% on average, when walking with the gait trainer overground compared to treadmill. When compared to typical baseline overground walking, overground gait trainer use caused individuals to have slightly less knee joint excursion (3°) and moderately more ankle joint excursion (7°). This work supports our vision of using the wearable robotic device as a gait aid and rehabilitation tool in the home and community settings.

Neural Correlates of Mobility in Children with Cerebral Palsy: A Systematic Review.

Recent advances in brain mapping tools have enabled the study of brain activity during functional tasks, revealing neuroplasticity after early brain injuries and resulting from rehabilitation. Understanding the neural correlates of mobility limitations is crucial for treating individuals with cerebral palsy (CP). The aim is to summarize the neural correlates of mobility in children with CP and to describe the brain mapping methods that have been utilized in the existing literature. This systematic review was conducted based on PRISMA guidelines and was registered on PROSPERO (n° CRD42021240296). The literature search was conducted in the PubMed and Embase databases. Observational studies involving participants with CP, with a mean age of up to 18 years, that utilized brain mapping techniques and correlated these with mobility outcomes were included. The results were analyzed in terms of sample characteristics, brain mapping methods, mobility measures, and main results. The risk of bias was evaluated using a checklist previously created by our research group, based on STROBE guidelines, the Cochrane Handbook, and the Critical Appraisal Skills Programme (CASP). A total of 15 studies comprising 313 children with CP and 229 with typical development using both static and mobile techniques met the inclusion criteria. The studies indicate that children"with'CP have increased cerebral activity and higher variability in brain reorganization during mobility activities, such as gait, quiet standing, cycling, and gross motor tasks when compared with children with typical development. Altered brain activity and reorganization underline the importance of conducting more studies to investigate the neural correlates during mobility activities in children with CP. Such information could guide neurorehabilitation strategies targeting brain neuroplasticity for functional gains.

The effect of vibration-hinged ankle foot orthoses on gait and spasticity in children with cerebral palsy: A randomized clinical trial design.

BACKGROUND: Hinged ankle foot orthoses (HAFO) are commonly prescribed for children with cerebral palsy (CP) to improve their ambulatory function. OBJECTIVES: The aim of this study was to compare the effect of vibration-HAFO with that of the same orthosis without vibration on gait, function, and spasticity in hemiplegic CP children. STUDY DESIGN: Randomized Control Trial Design (a pilot study). METHODS: Twenty-three children with hemiplegic CP participated in this study. The control group (n = 12) used HAFO, and the intervention group (n = 11) used vibration-HAFO for four weeks. Pre-post three-dimensional gait analysis was done. Calf muscle spasticity and function were also measured. RESULTS: Results showed significant differences between the two groups in the one-minute walking test (p = 0.023) and spasticity (after intervention [p = 0.022], after follow-up [p = 0.020]). Also, significant differences were detected between the two groups in the step width (p = 0.042), maximum hip abduction (p = 0.008), stance maximum dorsiflexion (p = 0.036) and mean pelvic tilt (p = 0.004) in the barefoot condition. Gait cycle time (p = 0.005), maximum hip abduction (p = 0.042), and cadence (p = 0.001) were different between groups in the braced condition. We couldn't find any significant within and between groups differences in knee kinematic parameters. The mean time of using vibration was 16.83 minutes per day. CONCLUSIONS: The vibration-hinged AFO is feasible, safe, and acceptable for children with hemiplegic CP to be integrated into practice. Temporospatial and clinical parameters, especially spasticity, were improved. There were slight trends toward improvement in pelvic and knee kinematics. Vibration-HAFO is of benefit to ambulatory CP children with mild and moderate spasticity. It improved the walking capacity of the children.

Validation of the Kinematic Assessment Protocol Used in the Technology-Supported Neurorehabilitation System, Rehabilitation Technologies for Hand and Arm (R3THA™), in Children and Teenagers with Cerebral Palsy.

This study evaluates the R3THA™ assessment protocol (R3THA-AP™), a technology-supported testing module for personalized rehabilitation in children with cerebral palsy (CP). It focuses on the reliability and validity of the R3THA-AP in assessing hand and arm function, by comparing kinematic assessments with standard clinical assessments. Conducted during a 4-week summer camp, the study assessed the functional and impairment levels of children with CP aged 3-18. The findings suggest that R3THA is more reliable for children aged 8 and older, indicating that age significantly influences the protocol's effectiveness. The results also showed that the R3THA-AP's kinematic measurements of hand and wrist movements are positively correlated with the Box and Blocks Test Index (BBTI), reflecting hand function and dexterity. Additionally, the R3THA-AP's accuracy metrics for hand and wrist activities align with the Melbourne Assessment 2's Range of Motion (MA2-ROM) scores, suggesting a meaningful relationship between R3THA-AP data and clinical assessments of motor skills. However, no significant correlations were observed between the R3THA-AP and MA2's accuracy and dexterity measurements, indicating areas for further research. These findings validate the R3THA-AP's utility in assessing motor abilities in CP patients, supporting its integration into clinical practice.

'I Didn't Know What Was Going to Happen': Children's and Young People's Experiences and Their Involvement Before and After Selective Dorsal Rhizotomy.

AIMS: To explore experiences, expectations, and involvement of children and young people (CYP) in decision-making for selective dorsal rhizotomy (SDR) surgery, post-operative physiotherapy treatment and outcomes. METHODS: A qualitative study design using one to one interviews. Five CYP (2 girls and 3 boys) participated, and interviews lasted between 45 min and 2 h. Data were analyzed using thematic analysis. RESULTS: Children and young people are reliant on their parents to make decisions and inform them of the SDR process. Experiences of living with cerebral palsy and its management are centered on their routine social, psychological, and physiological challenges. Individual characteristics and attributes of CYP have an impact on how they cope with the rehabilitation burden and adjust to their changing levels of function and participation. CONCLUSIONS: Although CYP reported that SDR offers them a greater 'freedom to choose' in how they participate in daily life, further consideration is required to meet their psychosocial needs, particularly in preparing for SDR and adjusting afterwards.

A usability study on the inGAIT-VSO: effects of a variable-stiffness ankle-foot orthosis on the walking performance of children with cerebral palsy.

BACKGROUND: Ankle-foot orthoses (AFOs) are commonly used by children with cerebral palsy (CP), but traditional solutions are unable to address the heterogeneity and evolving needs amongst children with CP. One key limitation lies in the inability of current passive devices to customize the torque-angle relationship, which is essential to adapt the support to the specific individual needs. Powered alternatives can provide customized behavior, but often face challenges with reliability, weight, and cost. Overall, clinicians find certain barriers that hinder their prescription. In recent work, the Variable Stiffness Orthosis (VSO) was developed, enabling stiffness customization without the need for motors or sophisticated control. METHODS: This work evaluates a pediatric version of the VSO (inGAIT-VSO) by investigating its impact on the walking performance of children with CP and its potential to be used as a tool for assessing the effect of variable stiffness on pathological gait. Data was collected for three typical developing (TD) children and six pediatric participants with CP over two sessions involving walking/balance tasks and questionnaires. RESULTS: The sensors of the inGAIT-VSO provided useful information to assess the impact of the device. Increasing the stiffness of the inGAIT-VSO significantly reduced participants' dorsiflexion and plantarflexion. Despite reduced range of motion, the peak restoring torque increased with stiffness. Overall the participants' gait pattern was altered by reducing crouch gait, preventing drop-foot and supporting body weight. Participants with CP exhibited significantly lower (p < 0.05) physiological cost when walking with the inGAIT-VSO compared to normal condition (own AFO or shoes only). Generally, the device did not impair walking and balance of the participants compared to normal conditions. According to the questionnaire results, the inGAIT-VSO was easy to use and participants reported positive experiences. CONCLUSION: The inGAIT-VSO stiffnesses significantly affected participants' plantarflexion and dorsiflexion and yielded objective data regarding walking performance in pathological gait (e.g. ankle angle, exerted torque and restored assistive energy). These effects were captured by the sensors integrated in the device without using external equipment. The inGAIT-VSO shows promise for customizing AFO stiffness and aiding clinicians in selecting a personalized stiffness based on objective metrics.

Repeated Transcranial Magnetic Stimulation Combined with Action Observation Training in Children with Spastic Cerebral Palsy.

This study presents the results of a randomized controlled trial utilizing a 2 x 2 factorial design, comparing the effects of repeated transcranial magnetic stimulation (rTMS) and action observation training (AOT) intervention methods on spasticity, balance function, and motor function in children with spastic cerebral palsy (SCP). The study aimed to investigate whether the combination of the two interventions produces greater improvement than either treatment alone or conventional treatment. Subject children in this study, in accordance with the random number table, were randomly divided into four groups: conventional group, rTMS group, AOT group, and combined intervention group. All the children in the four groups received conventional rehabilitation treatment, on the basis of which they were given different therapeutic programs of rehabilitation measures. The conventional group had no other treatment while the rTMS group received rTMS, the AOT group received AOT and the combined intervention group was given a combined intervention of rTMS and AOT. They were trained five days per week for 12 weeks. Changes in scores of spasticity, balance function, walking ability, and gross motor function were assessed at the onset of the training program and upon completion of 12 weeks of treatment. A total of 64 Children with SCP completed the study, and their results were analyzed. The total gross motor function efficiency of 87.50% in the experimental group was significantly higher than that of 25.00% in the conventional group, 62.50% in the rTMS group, and 68.75% in the AOT group. The preliminary results showed that combined intervention of rTMS and AOT could effectively improve the balance function and motor function of children, and the therapeutic effect of the combined intervention was better than that of conventional treatment, rTMS or AOT alone. Finally, clinical efficacy and optimal treatment parameters of the combined intervention were clarified to provide a clinical basis for therapists to conduct lower limb function rehabilitation for children with SCP.

Healthcare Professionals' Perspectives on the Use of Standing Frames for Children Diagnosed With Cerebral Palsy: An Explanatory Mixed Methods Study.

BACKGROUND: Standing frames are commonly used by healthcare professionals in their practice with children with cerebral palsy (CP) who do not have an independent standing function. A better understanding of healthcare professionals' attitudes and experiences with standing frames may impact practice and rehabilitation. Therefore, this study aimed to investigate the standing frame practice among healthcare professionals and expand their attitude and experience with the use of standing frames for children with CP. METHODS: This is an explanatory sequential mixed methods study. A cross-sectional survey was conducted, providing quantitative data on 210 healthcare professionals' use of standing frames. The quantitative data were descriptively analysed. Subsequently, the results from the survey were followed up with five focus group interviews of healthcare professionals (n = 14). The qualitative data were analysed using thematic analysis, enabling integration between the quantitative and qualitative data. RESULTS: When quantitative and qualitative data are integrated, expansion between the two datasets occurred. The quantitative dataset emphasised the use of GMFCS levels as a guideline for recommending standing frames, whereas the qualitative data showed that the healthcare professionals' recommendations were based on individual needs. Furthermore, the healthcare professionals expanded the quantitative data, showing that the healthcare professionals' considerations regarding age and dosage were based on clinical experience, and saw the standing frame as having many benefits. CONCLUSION: The healthcare professionals had a child-centred approach, where the child's need for using a standing frame was assessed based on the functional level, stage of development, cognitive level and clinical assessment. All of these considerations showed that the use of standing frames for children with CP was individualised, thereby making it difficult to make unified descriptions.

EPIC-CP pilot trial study protocol: a multicentre, randomised controlled trial investigating the feasibility and acceptability of social prescribing for Australian children with cerebral palsy.

INTRODUCTION: The social determinants of health contribute to poorer health outcomes for children with cerebral palsy (CP) and are barriers to families accessing health services. At an individual level, social determinants of health are experienced as unmet social needs, for example, unsafe housing conditions. There is emerging evidence that clinical pathways for the systematic identification and referral to services for unmet social needs can support families to address these needs. These clinical pathways have not been implemented for children with CP. The objectives are to investigate the feasibility and acceptability of two co-designed social needs clinical pathways for parents/caregivers of children with CP-social prescribing (ie, Community Linker plus resource pack) compared with resource pack only. METHODS AND ANALYSIS: This pilot randomised controlled trial will run at the three tertiary paediatric rehabilitation services in New South Wales, Australia. A total of 120 participants will be recruited, with randomisation stratified by study site. A survey tool will be used to identify families experiencing unmet social needs. Parents/caregivers who report one or more unmet social need/s and consent will be eligible. The active control group will receive a resource pack containing information on community services to support unmet social needs. The social prescribing intervention group will receive one-on-one Community Linker support, in addition to the resource pack. The survey tool, intervention, logic model, and resource pack were co-designed with patient families and their healthcare workers. Feasibility of the research design and the clinical pathways will be evaluated using the number/proportion of parents/caregivers who complete the survey tool, consent, engage with the intervention, and complete research measures. Acceptability will be evaluated using questionnaires and qualitative interviews. ETHICS AND DISSEMINATION: Human research ethics approval was granted by the Sydney Children's Hospitals Network Human Research Ethics Committee (2022/ETH01688). Participants and stakeholders will receive updates and findings via regular communication channels including meetings, presentations, and publications. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry: 12622001459718.

A randomized cross-over study protocol to evaluate long-term gait training with a pediatric robotic exoskeleton outside the clinical setting in children with movement disorders.

Individuals with neuromuscular disorders display a combination of motor control deficits and lower limb weakness contributing to knee extension deficiency characterized by exaggerated stance phase knee flexion. There is a lack of evidence for long-term improvement of knee extension deficiency with currently available clinical treatment programs. Our previous work testing a wearable robotic exoskeleton with precisely timed assistive torque applied at the knee showed immediate increases in knee extension during walking for children with cerebral palsy, which continued to improve over an acute practice period. When we applied interleaved assistance and resistance to knee extension, we observed improvements in knee extension and increased muscle activation indicating the potential for muscle strengthening when used over time. There is a need for additional, high-quality trials to assess the impact of dosage, intensity and volume of training necessary to see persistent improvement in lower limb function for these patient populations. This randomized crossover study (ClinicalTrials.gov: NCT05726591) was designed to determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting, following an initial in clinic accommodation period, has a beneficial effect on walking ability, muscle activity and overall motor function. Participants will be randomized to either complete the exoskeleton intervention or continue their standard therapy for 12 weeks first, followed by a crossover to the other study component. The primary outcome measure is change in peak knee extension angle during walking; secondary outcome measures include gait speed, strength, and validated clinical scales of motor function and mobility. Assessments will be completed before and after the intervention and at 6 weeks post-intervention, and safety and compliance will be monitored throughout. We hypothesize that the 12-week exoskeleton intervention outside the clinical setting will show greater improvements in study outcome measures than the standard therapy.

Overground Gait Training With a Wearable Robot in Children With Cerebral Palsy: A Randomized Clinical Trial.

Importance: Cerebral palsy (CP) is the most common developmental motor disorder in children. Robot-assisted gait training (RAGT) using a wearable robot can provide intensive overground walking experience. Objective: To investigate the effectiveness of overground RAGT in children with CP using an untethered, torque-assisted, wearable exoskeletal robot. Design, Setting, and Participants: This multicenter, single-blind randomized clinical trial was conducted from September 1, 2021, to March 31, 2023, at 5 rehabilitation institutions in Korea. Ninety children with CP in Gross Motor Function Classification System levels II to IV were randomized. Intervention: The RAGT group underwent 18 sessions of RAGT during 6 weeks, whereas the control group received standard physical therapy for the same number of sessions during the same period. Main Outcome and Measures: The primary outcome measure was the Gross Motor Function Measure 88 (GMFM-88) score. Secondary outcome measures were the GMFM-66, Pediatric Balance Scale, selective control assessment of the lower extremity, Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), 6-minute walking test scores (distance and oxygen consumption), muscle and fat mass via bioelectrical impedance analysis, and gait parameters measured via 3-dimensional analysis. All assessments were performed for all patients at baseline, at the end of the 6-week intervention, and after the 4-week follow-up. Results: Of the 90 children (mean [SD] age, 9.51 [2.48] years; 49 [54.4%] male and 41 [45.6%] female) in the study, 78 (86.7%) completed the intervention, with 37 participants (mean [SD] age, 9.57 [2.38] years; 19 [51.4%] male) and 41 participants (mean [SD] age, 9.32 [2.37] years; 26 [63.4%] male) randomly assigned to the RAGT and control groups, respectively. Changes in the RAGT group significantly exceeded changes in the control group in GMFM-88 total (mean difference, 2.64; 95% CI, 0.50-4.78), GMFM-E (mean difference, 2.70; 95% CI, 0.08-5.33), GMFM-66 (mean difference, 1.31; 95% CI, 0.01-2.60), and PEDI-CAT responsibility domain scores (mean difference, 2.52; 95% CI, 0.42-4.63), indicating independence in daily living at postintervention assessment. At the 4-week follow-up, the RAGT group showed significantly greater improvements in balance control (mean difference, 1.48; 95% CI, 0.03-2.94) and Gait Deviation Index (mean difference, 6.48; 95% CI, 2.77-10.19) compared with the control group. Conclusions and Relevance: In this randomized clinical trial, overground RAGT using a wearable robot significantly improved gross motor function and gait pattern. This new torque-assisted wearable exoskeletal robot, based on assist-as-needed control, may complement standard rehabilitation by providing adequate assistance and therapeutic support to children with CP. Trial Registration: CRIS Identifier: KCT0006273.

Effectiveness of therapeutic interventions on participation in children with cerebral palsy: A systematic review and meta-analysis.

BACKGROUND: Participation in life activities is an integral part of health and a main outcome of rehabilitation services for children and adolescents with disabilities. However, there is still no consensus on the most effective way to improve participation. The aim of this systematic review is to determine the effectiveness of therapeutic interventions on participation outcomes of children with cerebral palsy (CP). METHODS: A systematic review was conducted, searching the databases PubMed, Cochrane Library, Science Direct, Web of Science and Scopus for randomized controlled trials (RCTs), between 2001 and 2023. Studies were eligible for inclusion if they evaluated children with CP undergoing any intervention and using any tool measuring participation as an outcome measure. A meta-analysis of treatment effect was conducted. A sensitivity analysis was conducted to identify the effect on participation when intervention targeted different International Classification of Functioning (ICF) domains. RESULTS: A total of 1572 records were identified. Eight RCTs including 384 children (195 in the intervention group and 189 in the control group) were included in the systematic review and in the meta-analysis. A sensitivity analysis showed that interventions focusing on participation significantly improved participation; standardized mean difference (1.83; 95% CI: 1.33-2.32; Z = 7.21; P < 0.00001). When other types of interventions, that is, focusing on body functions and structures or activities, were used, then participation was not favourably affected. INTERPRETATION: Interventions primarily targeting barriers to participation across several ICF domains have a greater influence on enhancing participation. Interventions aimed at enhancing specific motor skills, including gross and fine motor function or strength, do not necessarily have a positive impact on participation.

How best to support parents in the management of standing frame usage in home settings: A mixed methods study.

BACKGROUND: An improved understanding of the current practice of standing frame use may have implications for supporting parents in managing standing frames. We aimed to investigate how parents of children with cerebral palsy perceive and manage standing frame use in home settings. METHODS: We conducted a mixed methods study with an explanatory sequential design, first collecting and analysing quantitative questionnaire data and then using these results to inform a qualitative follow-up phase to explain them. The questionnaire was answered by 103 parents of children with cerebral palsy across five countries, Denmark, Norway, Great Britain, Canada and the United States, and 12 Danish families participated in the subsequent interviews. A descriptive analysis was conducted using the questionnaire data. The qualitative data were analysed using a directed content analysis, enabling integration of the quantitative and qualitative data. RESULTS: The quantitative analysis showed that 89% of the parents felt confident with their child's standing frame, and 82% felt they had sufficient knowledge about how their child's standing frame could/should be used. However, the qualitative analysis showed that even when feeling confident, the parents experienced insecurity regarding whether their child was positioned correctly, and being responsible for positioning was challenging. CONCLUSION: Our study implies a need for providing educational materials to assist the parents in ensuring optimal positioning of their child in the standing frame to decrease insecurity. Additionally, our study suggests a need to provide more thorough information about the benefits of using a standing frame and ensure alignment of expectations in relation to the child's prognosis of functional independence.