Locomotor and robotic assistive gait training for children with cerebral palsy.

AIM: To determine if robotic assisted gait training (RAGT) using surface muscle electrical stimulation and locomotor training enhances mobility outcomes when compared to locomotor training alone in children with cerebral palsy (CP). METHOD: Forty children (18 females, 22 males; mean age 8y 1mo, SD 2y 1mo; range 5y 1mo-12y 11mo) with CP in Gross Motor Function Classification System levels (GMFCS) III, IV, and V were randomly assigned to the RAGT and locomotor training (RAGT+LT) group or locomotor training only group (dosage for both: three 1-hour sessions a week for 6 weeks). Outcomes were assessed at baseline T1 (week 0), post-treatment T2 (week 6), and retention T3 (week 26). The primary outcome measure was the Goal Attainment Scale. Secondary outcome measures included the 10-metre walk test, children's functional independence measure mobility and self-care domain, the Canadian Occupational Performance Measure, and the Gross Motor Function Measure. RESULTS: There were no significant differences between the groups for both the primary and secondary outcome measures. All participants completed the intervention in their original group allocation. There were no reported adverse events. INTERPRETATION: The addition of RAGT to locomotor training does not significantly improve motor outcomes in children with CP in GMFCS levels III, IV, and V. Future studies could investigate health and well-being outcomes after locomotor training. WHAT THIS PAPER ADDS: Marginally ambulant and non-ambulant children with cerebral palsy can participate in locomotor training. Robotic assisted gait training when added to locomotor training does not appear to be any more effective than locomotor training alone.

Neuromuscular electrical stimulation-assisted gait increases muscle strength and volume in children with unilateral spastic cerebral palsy.

AIM: To determine if neuromuscular electrical stimulation (NMES) applied to the ankle dorsiflexors during gait improves muscle volume and strength in children with unilateral spastic cerebral palsy (CP). METHOD: Thirty-two children (15 females, 17 males; mean age 10y 8mo, age range 5y 5mo-18y 1mo) with unilateral spastic CP and a Gross Motor Function Classification System of level I or level II were randomly assigned to either the 8-week daily NMES treatment group or control group (usual or conventional treatments). Outcomes at week 8 (post-NMES) and week 14 (carryover) included magnetic resonance imaging for muscle volumes (tibialis anterior, anterior compartment, and gastrocnemius), strength (hand-held dynamometry for isometric dorsiflexion strength and heel raises for functional strength), and clinical measures for lower limb selective motor control. RESULTS: At week 8, the treatment group demonstrated significantly (p<0.05) increased muscle volumes for tibialis anterior, anterior compartment, medial and lateral gastrocnemius, and dorsiflexion strength not only when compared to their baseline values but also when compared to the control group at week 8. At week 14, both tibialis anterior and lateral gastrocnemius volumes in the treatment group remained significantly increased when compared to their baseline values. However, only lateral gastrocnemius volumes had significantly greater values when compared to the control group at week 14. There were no between group differences in the clinical measures for lower limb selective motor control at week 8 and 14. INTERPRETATION: Eight weeks of daily NMES-assisted gait increases muscle volume and strength of the stimulated ankle dorsiflexors in children with unilateral spastic CP. These changes are use-dependent and do not carry over after the 8-week treatment period. Gastrocnemius volume also increased post-treatment with carryover at week 14.

The orthotic and therapeutic effects following daily community applied functional electrical stimulation in children with unilateral spastic cerebral palsy: a randomised controlled trial.

BACKGROUND: The purpose of this study was to determine the orthotic and therapeutic effects of daily community applied FES to the ankle dorsiflexors in a randomized controlled trial. We hypothesized that children receiving the eight-week FES treatment would demonstrate orthotic and therapeutic effects in gait and spasticity as well as better community mobility and balance skills compared to controls not receiving FES. METHODS: This randomized controlled trial involved 32 children (mean age 10 yrs 3 mo, SD 3 yrs 3 mo; 15 females, 17 males) with unilateral spastic cerebral palsy and a Gross Motor Function Classification System of I or II randomly assigned to a FES treatment group (n = 16) or control group (n = 16). The treatment group received eight weeks of daily FES (four hours per day, six days per week) and the control group received usual orthotic and therapy treatment. Children were assessed at baseline, post FES treatment (eight weeks) and follow-up (six weeks after post FES treatment). Outcome measures included lower limb gait mechanics, clinical measures of gastrocnemius spasticity and community mobility balance skills. RESULTS: Participants used the FES for a mean daily use of 6.2 (SD 3.2) hours over the eight-week intervention period. With FES, the treatment group demonstrated a significant (p < 0.05) increase in initial contact ankle angle (mean difference 11.9° 95% CI 6.8° to 17.1°), maximum dorsiflexion ankle angle in swing (mean difference 8.1° 95% CI 1.8° to 14.4°) normalized time in stance (mean difference 0.27 95% CI 0.05 to 0.49) and normalized step length (mean difference 0.06 95% CI 0.003 to 0.126) post treatment compared to the control group. Without FES, the treatment group significantly increased community mobility balance scores at post treatment (mean difference 8.3 units 95% CI 3.2 to 13.4 units) and at follow-up (mean difference 8.9 units 95% CI 3.8 to 13.9 units) compared to the control group. The treatment group also had significantly reduced gastrocnemius spasticity at post treatment (p = 0.038) and at follow-up (dynamic range of motion mean difference 6.9°, 95% CI 0.4° to 13.6°; p = 0.035) compared to the control group. CONCLUSION: This study documents an orthotic effect with improvement in lower limb mechanics during gait. Therapeutic effects i.e. without FES were observed in clinical measures of gastrocnemius spasticity, community mobility and balance skills in the treatment group at post treatment and follow-up. This study supports the use of FES applied during daily walking activities to improve gait mechanics as well as to address community mobility issues among children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register ACTRN12614000949684 . Registered 4 September 2014.

Effects of short-term daily community walk aide use on children with unilateral spastic cerebral palsy.

PURPOSE: To determine the effects of functional electrical stimulation (FES) on the main impairments affecting gait in children with unilateral spastic cerebral palsy. METHODS: A 20-week, multiple single-subject A-B-A design included a 6-week pre-FES phase, an 8-week FES phase, and a 6-week post-FES phase. Twelve children, aged 5 to 16 years, wore an FES device (the Walk Aide) daily for 8 weeks. Weekly measures included ankle range of motion, selective motor control, dorsiflexion and plantar flexion strength, gastrocnemius spasticity, single-limb balance, Observational Gait Scale (OGS) score, and self-reported toe drag and falls in the community. RESULTS: Compared with the pre-FES phase, the FES phase showed significant improvements in ankle range of motion, selective motor control and strength, and reductions in spasticity, toe drag, and falls, but no change in OGS score. These improvements were maintained during the post-FES phase. CONCLUSIONS: Intermittent, short-term use of FES is potentially effective for reducing impairments affecting gait in children with unilateral spastic cerebral palsy.

Outcomes following intensive day rehabilitation for young people in Western Australia.

OBJECTIVE: Intensive rehabilitation aims to improve and maintain functioning in young people who experience disability due to illness or injury. Day rehabilitation may have advantages for families and healthcare systems over inpatient models of rehabilitation. METHODS: This study evaluated the goals and outcomes of a cohort of young people in Western Australia who attended a specialist intensive day rehabilitation programme ("iRehab") at Perth Children's Hospital. Analysis of the iRehab service database was performed. Rehabilitation goals and outcomes were recorded as per the Canadian Occupational Performance Measure (COPM), Children's Functional Independence Measure (WeeFIM), and Goal Attainment Scale (GAS). RESULTS: There were 586 iRehab admissions between August 11, 2011, and December 31, 2018. Admissions were divided by diagnosis: Cerebral Palsy (228, 38.5%), Acquired Brain Injury (125, 21.3%), Spinal Cord Disorders (91, 15.5%), and Other (141, 24.2%). Mean COPM Performance increased by 2.78 points from admission to discharge (95% CI 2.58 to 2.98, p < 0.001). Mean COPM Satisfaction was 3.29 points higher at discharge than admission (95% CI 3.07 to 3.51, p < 0.001). Mean total WeeFIM score improved by 6.51 points between admission and discharge (95% CI 5.56 to 7.45, p < 0.001), and by 3.33 additional points by six months post discharge (95% CI 2.14 to 4.53, p < 0.001). Mean GAS T-scores increased by 27.85 (95% CI 26.73 to 28.97, p < 0.001) from admission to discharge, and by 29.64 (95% CI 28.26 to 31.02, p < 0.001) from admission to six months post discharge, representing improvement consistent with team expectations. CONCLUSION: This study describes a model by which intensive rehabilitation can be delivered in a day rehabilitation setting. A diverse population of young people who experienced disability achieved significant improvements in occupational performance, independence, and goal attainment after accessing intensive day rehabilitation. Improvements were measured in all diagnostic subgroups and were maintained six months after discharge.

Kindy Moves: the feasibility of an intensive interdisciplinary programme on goal and motor outcomes for preschool-aged children with neurodisabilities requiring daily equipment and physical assistance.

OBJECTIVES: To determine the feasibility of an intensive interdisciplinary programme in improving goal and motor outcomes for preschool-aged children with non-progressive neurodisabilities. The primary hypothesis was that the intervention would be feasible. DESIGN: A single group feasibility study. SETTING: An Australian paediatric community therapy provider. PARTICIPANTS: Forty children were recruited. Inclusion criteria were age 2-5 years with a non-progressive neurodisability, Gross Motor Function Classification System (GMFCS) levels III-V or equivalent, and goals relating to mobility, communication and upper limb function. Exclusion criteria included orthopaedic surgery in the past 6 months, unstable hip subluxation, uncontrolled seizure disorder or treadmill training in the past month. INTERVENTION: A goal-directed programme of three 2-hour sessions per week for 4 weeks (24 hours total). This consisted of treadmill and overground walking, communication practice, and upper limb tasks tailored by an interdisciplinary team. PRIMARY AND SECONDARY OUTCOME MEASURES: Limited-efficacy measures from preintervention (T1) to postintervention (T2) and 4-week follow-up (T3) included the Goal Attainment Scaling (GAS), Canadian Occupational Performance Measure (COPM), Gross Motor Function Measure (GMFM-66) and 10-Metre Walk Test (10MWT). Acceptability, demand, implementation and practicality were also explored. RESULTS: There were improvements at T2 compared with T1 for all limited-efficacy measures. The GAS improved at T2 (mean difference (MD) 27.7, 95% CI 25.8 to 29.5) as well as COPM performance (MD 3.2, 95% CI 2.8 to 3.6) and satisfaction (MD 3.3, 95% CI 2.8 to 3.8). The GMFM-66 (MD 2.3, 95% CI 1.0 to 3.5) and 10MWT (median difference -2.3, 95% CI -28.8 to 0.0) improved at T2. Almost all improvements were maintained at T3. Other feasibility components were also demonstrated. There were no adverse events. CONCLUSIONS: An intensive interdisciplinary programme is feasible in improving goal and motor outcomes for preschool children with neurodisabilities (GMFCS III-V or equivalent). A randomised controlled trial is warranted to establish efficacy. TRIAL REGISTRATION NUMBER: ACTRN12619000064101.

ACTIVE STRIDES-CP: protocol for a randomised trial of intensive rehabilitation (combined intensive gait and cycling training) for children with moderate-to-severe bilateral cerebral palsy.

INTRODUCTION: For children with cerebral palsy (CP), who are marginally ambulant, gross motor capacity peaks between 6 and 7 years of age with a subsequent clinical decline, impacting their ability to engage in physical activity. Active Strides-CP is a novel package of physiotherapy targeting body functions, activity and participation outcomes for children with bilateral CP. This study will compare Active Strides-CP to usual care in a multisite randomised waitlist-controlled trial. METHODS AND ANALYSIS: 150 children with bilateral CP (5-15 years), classified in Gross Motor Function Classification System (GMFCS) levels III and IV will be stratified (GMFCS III vs IV, age 5-10 years; 11-15 years and trial site) and randomised to receive either (1) 8 weeks of Active Strides-CP two times/week for 1.5 hours in clinic and one time/week for 1 hour alternating home visits and telehealth (total dose=32 hours) or (2) usual care. Active Strides-CP comprises functional electrical stimulation cycling, partial body weight support treadmill training, overground walking, adapted community cycling and goal-directed training. Outcomes will be measured at baseline, immediately post-intervention at 9 weeks primary endpoint and at 26 weeks post-baseline for retention. The primary outcome is the Gross Motor Function Measure-66. Secondary outcomes include habitual physical activity, cardiorespiratory fitness, walking speed and distance, frequency/involvement of community participation, mobility, goal attainment and quality of life. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. A within-trial cost utility analysis will be performed. ETHICS AND DISSEMINATION: The Children's Health Queensland Hospital and Health Service, The University of Queensland, The University of Melbourne and Curtin University Human Research Ethics Committees have approved this study. Results will be disseminated as conference abstracts and presentations, peer-reviewed articles in scientific journals, and institution newsletters and media releases. TRIAL REGISTRATION NUMBER: ACTRN12621001133820.

Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy.

INTRODUCTION: Preschool aged children with cerebral palsy (CP) and like conditions are at risk of performing below their peers in key skill areas of school readiness. Kindy Moves was developed to support school readiness in preschool aged children with CP and like conditions that are dependent on physical assistance and equipment throughout the day. The primary aims are to determine the feasibility of motor-based interventions that are functional and goal directed, adequately dosed and embedded into a play environment with interdisciplinary support to optimise goal-driven outcomes. METHODS AND ANALYSIS: Forty children with CP and like conditions aged between 2 and 5 years with a Gross Motor Function Classification System (GMFCS) level of III-V or equivalent, that is, dependent on physical assistance and equipment will be recruited in Western Australia. Participants will undertake a 4-week programme, comprised three, 2-hour sessions a week consisting of floor time, gross motor movement and play (30 min), locomotor treadmill training (30 min), overground walking in gait trainers (30 min) and table-top activities (30 min). The programme is group based with 3-4 children of similar GMFCS levels in each group. However, each child will be supported by their own therapist providing an interdisciplinary and goal directed approach. Primary outcomes of this feasibility study will be goal attainment (Goal Attainment Scale) and secondary outcomes will include Canadian Occupational Performance Measure, 10 metre walk test, Children's Functional Independence Measure, Sleep Disturbance Scale, Infant and Toddler Quality of Life Questionnaire, Peabody Developmental Motor Scale and Gross Motor Function Measure. Outcomes will be assessed at baseline, post intervention (4 weeks) and retention at the 4-week follow-up. ETHICS AND DISSEMINATION: Ethical approval was obtained from Curtin University Human Ethics Committee (HRE2019-0073). Results will be disseminated through published manuscripts in peer-reviewed journals, conference presentations and public seminars for stakeholder groups. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12619000064101p).

The Experience of Locomotor Training From the Perspectives of Therapists and Parents of Children With Cerebral Palsy.

Objective: The objective of this study was to explore the experiences of intensive locomotor training from the perspective of therapists and parents of children with cerebral palsy. Design: A qualitative study using semi-structured interviews was employed to capture perspectives following an intensive locomotor training intervention. Data were analyzed thematically, systematically coding and interpreted by grouping information into themes and sub-theme categories. Participants: Five therapists and seven parents of children with high daily physical assistance and equipment needs participated in the study. Setting: A pediatric tertiary hospital. Results: Experiences of locomotor training were described with relation to the suitability of locomotor training with sub-themes of intervention length and time, engagement within sessions, the importance of support, and the utility of locomotor training beyond a research context. Motivation for participating in locomotor training was described in relation to the enjoyment of movement and for increasing activity level. The barriers and facilitators who participated in locomotor training provided environmental and personal factor subthemes. Finally, the outcomes from the intervention were related to improvements in physical health, sleep, affect and emotion, and ambulation in daily activities. Conclusion: The experience of intensive locomotor training from the perspectives of parents of children who have high physical assistance and equipment needs and the therapists providing the intervention was described. Future studies should consider outcome measures beyond motor capacity to quantify the perceived outcomes of interventions that are meaningful to families.

Daily functional electrical stimulation during everyday walking activities improves performance and satisfaction in children with unilateral spastic cerebral palsy: a randomized controlled trial.

BACKGROUND: The aim of this paper is to determine whether daily functional electrical stimulation (FES) is effective in improving self-perceptions of individually identified mobility performance problems in children with unilateral spastic cerebral palsy (USCP). We hypothesized that children receiving 8 weeks of FES treatment would have higher scores for self-perceived performance and satisfaction on the Canadian Occupational Performance Measure (COPM) for individually identified priorities than children not receiving FES. METHODS: Thirty-two children (mean age 10 y 8 mo SD 3y 3mo) with USCP and a Gross Motor Function Classification System I or II were randomly assigned to the FES treatment group (8 weeks of daily FES) and control group (usual treatments). Participants were assessed at baseline (week 0), post treatment (week 8) and 6 weeks follow-up (week 14). The primary outcome measures were self-perceived scores for performance and satisfaction of child- and parent-identified priorities assessed using the COPM post treatment and at follow-up. The secondary outcome measures were the categorization of the performance problems from the COPM and self-report responses according to the International Classification of Functioning Child and Youth version (ICF-CY). This was clinically important because an understanding of mobility performance problems for children with USCP is needed for family-centred service planning. RESULTS: Performance scores (mean difference 1.6, 95 % CI 0.1 to 3.2, p = 0.034) and satisfaction scores post treatment (mean difference 2.4, 95 % CI 0.5 to 4.2, p = 0.004) were significantly higher in the treatment group than in the control group. There were no significant differences between the groups for performance scores at follow up, however there was a significant difference between the groups for satisfaction (mean difference 1.9, 95 % CI 0.1 to 3.8, p = 0.03) in favour of the treatment group. Priorities were identified across all levels of the ICF-CY but were most commonly identified in the activity and participation domains of the ICF-CY (79.5 %). CONCLUSIONS: Daily FES applied during everyday walking is effective in addressing self-perceptions of individually identified priorities by improving the performance and satisfaction of functional skills after treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register ACTRN12614000949684. Registered 4 September 2014.