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Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol.

ABSTRACT: INTRODUCTION:Cerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600-700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural principles: Strengthening Mental Abilities through Relational Training (SMART). The study aims to investigate SMART's effect on fluid reasoning, executive function and academic achievement in children with CP. METHODS AND ANALYSIS:Sixty children with mild to moderate CP (Gross Motor Function Classification Scale I-IV) aged between 8 years and 12 years will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the programme at home over a 4-month period. Assessments will be administered at baseline, 20?weeks and at 40?week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes. ETHICS AND DISSEMINATION:This study has approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace. REGISTRATION DETAILS:The study was registered prospectively on 10 November 2017 to present. Recruitment is now under way, and we aim to complete recruitment by June 2019, with data collection finalised by March 2020. TRIAL REGISTRATION NUMBER:ACTRN12617001550392; Pre-results.

SUBMITTER: Wotherspoon J

PROVIDER: S-EPMC6561461 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol.

Wotherspoon Jane J Whittingham Koa K Boyd Roslyn N RN Sheffield Jeanie J

BMJ open 20190604 6

<h4>Introduction</h4>Cerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600-700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural ...[more]

PMID: 31167872

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Project description:INTRODUCTION:Two-wheel bike riding can be a goal for children with cerebral palsy (CP) and a means of participating in physical activity. It is possible for some children with CP to ride a two-wheel bike; however, currently far fewer can ride compared with their typically developing peers. Evidence supports training targeted towards goals of the child with CP and their family; yet there is little evidence to guide best-practice bike skills training. Task-specific training may lead to attainment of two-wheel bike-specific goals. This study aims to determine if a novel task-specific approach to training two-wheel bike skills is more effective than a parent-led home programme for attaining individualised two-wheel bike-specific goals in independently ambulant children with CP aged 6-15 years. METHODS AND ANALYSIS:Sixty eligible children with CP (Gross Motor Function Classification System levels I-II) aged 6-15 years with goals relating to riding a two-wheel bike will be randomised to either a novel task-specific centre-based group programme (intervention) or a parent-led home-based programme (comparison), both involving a 1-week intervention period. The primary outcome is goal attainment in the week following the intervention period (T1). Secondary outcomes include: goal attainment and participation in physical activity at 3?months postintervention (T2) and bike skills, attendance and involvement in bike riding, self-perception and functional skills at T1 and T2. Economic appraisal will involve cost-effectiveness and cost-utility analyses. Adherence of clinicians and parents to the intervention and comparison protocols will be assessed. Linear and logistic regression will be used to assess the effect of the intervention, adjusted for site as used in the randomisation process. ETHICS AND DISSEMINATION:This study was approved by the Human Research and Ethics Committees at The Royal Children's Hospital (#36209). Results will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT03003026; Pre-results.

Project description:IntroductionCerebral palsy (CP) is the most common childhood physical disability, with life-long impacts for 1.77 in 1000 children. Although CP is primarily a physical disability, children with CP have an increased risk of experiencing cognitive difficulties, particularly attention and executive function deficits. Impairment in cognitive abilities can lead to subsequent impairment in independent functioning, education, employment and interpersonal relationships. This paper reports the protocol of a randomised controlled trial of a novel family-centred lifestyle intervention based on mindfulness and hatha yoga principles (MiYoga). MiYoga aims to enhance child and parent outcomes for children with CP.Methods and analysisThe aim is to recruit 36 child-parent dyads (children aged 6-16 years; bilateral or unilateral CP; Gross Motor Function Classification System I-III), who will be randomly assigned to two groups: MiYoga andwaitlistt control. The MiYoga programme will be facilitated in a group format for 8 weeks. Assessments will be administered at baseline, prior to MiYoga, following completion of MiYoga, and at 6-month follow-up (retention). The primary outcome will be the child's sustained attentional ability as measured by the Conner's Continuous Performance Test II. Other outcomes of interest for children with CP consists of attentional control, physical functioning, behavioural and well-being. For parents, the outcomes of interest are mindfulness, psychological flexibility and well-being. Data will be analysed using general linear models, specifically analysis of covariance and analysis of variance.Ethics and disseminationFull ethical approval for this study has been obtained by the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/12/QRCH/120) and The University of Queensland (2012000993). If MiYoga is proven effective, its dissemination would assist children with CP and complement their ongoing therapy by improving the ability of the child to pay attention at school and in therapy, and alleviating environmentalstressorss for both the child and his/her parents.Trial registration numberACTRN12613000729729; Pre-results.http://www.ANZCTR.org.au/ACTRN12613000729729.aspx DATE OF TRIAL REGISTRATION: Prospectively registered on 2 July 2013-present (ongoing).Findings to dateRecruitment is complete. Data are still being collected at present. We aim to complete data collection by February 2017.

Project description:INTRODUCTION:Children with cerebral palsy (CP) and other neurodevelopmental disabilities often receive a home programme of exercises to assist in reaching their therapy goals. Adherence to exercise programmes is necessary to attain the level of practice required to achieve goals; however, adherence can be difficult to accomplish. In this paper, we describe the protocol for a randomised controlled trial to evaluate the effectiveness of delivering a home exercise programme to school-age children with disabilities using Physitrack, an online exercise prescription tool with a website or app interface. METHODS AND ANALYSIS:Participants aged 6-17 years, with CP or other neurodevelopmental disabilities, receiving community physiotherapy services in Western Australia, will be recruited. Participants will be stratified by age and functional mobility and randomised to either the intervention group, who will complete an 8-week home exercise programme using Physitrack, or the control group, who will complete an 8-week exercise programme without Physitrack. Researcher blinding to group allocation, and participant blinding to outcome, will be maintained. The primary outcome measures are adherence to the home exercise programme with weekly collection of home exercise logs; achievement of individualised goals by phone interview before and after intervention; and correctness of exercise performance by collection and analysis of videos of participants performing home exercises. Secondary outcome measures include enjoyment of physical activity, confidence to complete exercise programme, preferred method of delivery of programme and usability of Physitrack. A sample size of 58 participants will be necessary to see an effect on home programme adherence. Data will be analysed using the intention-to-treat principle. ETHICS AND DISSEMINATION:Ethical approval was obtained from Curtin University Human Research Ethics Committee in July 2016 (10391). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER:ACTRN12616000743460; Pre-results.

Project description:IntroductionCerebral palsy (CP) is the most common childhood-onset motor disorder accompanied by associated impairments, placing a heavy burden on families and health systems. Most children with CP live in low/middle-income countries with little access to rehabilitation services. This study will evaluate the Akwenda CP programme, a multidimensional intervention designed for low-resource settings and aiming at improving: (1) participation, motor function and daily activities for children with CP; (2) quality of life, stress and knowledge for caregivers; and (3) knowledge and attitudes towards children with CP in the communities.MethodsThis quasi-randomised controlled clinical study will recruit children and youth with CP aged 2-23 years in a rural area of Uganda. Children will be allocated to one of two groups with at least 44 children in each group. Groups will be matched for age, sex and motor impairment. The intervention arm will receive a comprehensive, multidimensional programme over a period of 11 months comprising (1) caregiver-led training workshops, (2) therapist-led practical group sessions, (3) provision of technical assistive devices, (4) goal-directed training and (5) community communication and advocacy. The other group will receive usual care. The outcome of the intervention will be assessed before and after the intervention and will be measured at three levels: (1) child, (2) caregiver and (3) community. Standard analysis methods for randomised controlled trial will be used to compare groups. Retention of effects will be examined at 12-month follow-up.Ethics and disseminationThe study has been approved by the Uganda National Council for Science and Technology (SS 5173) and registered in accordance with WHO and ICMJE standards. Written informed consent will be obtained from caregivers. Results will be disseminated among participants and stakeholders through public engagement events, scientific reports and conference presentations.Trial registration numberPan African Clinical Trials Registry (PACTR202011738099314) Pre-results.

Project description:BackgroundCerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises.ObjectiveThe aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP.MethodsThe protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel.ResultsThe trial has not started and is pending local institutional review board approval.ConclusionsMovement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.Trial registrationClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP).International registered report identifier (irrid)PRR1-10.2196/11470.

Project description:IntroductionPoverty is a key contributor to delayed diagnosis and limited access to early intervention and rehabilitation for children with cerebral palsy (CP) in rural Bangladesh. 97% of families of children with CP live below the poverty line in Bangladesh. Therefore, in low-and middle-income countries (LMICs), efforts to improve outcomes for children with CP (including health-related quality of life, motor function, communication, and nutritional attainments) should also include measures to improve family economic and social capital. We propose a randomised controlled trial (RCT) to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh.Material and methodsThis will be a cluster RCT comparing three arms: (a) integrated microfinance/livelihood and community-based rehabilitation (IMCBR); (b) community-based rehabilitation (CBR) alone; and (c) care-as-usual (i.e. no intervention). Seven clusters will be recruited within each arm. Each cluster will consist of 10 child-caregiver dyads totalling 21 clusters with 210 dyads. Parents recruited in the IMCBR arm will take part in a microfinance/livelihood program and Parent Training Module (PTM), their children with CP will take part in a Goal Directed Training (GDT) program. The programs will be facilitated by specially trained Community Rehabilitation Officers. The CBR arm includes the same PTM and GDT interventions excluding the microfinance/livelihood program. The care-as-usual arm will be provided with information about early intervention and rehabilitation. The assessors will be blinded to group allocation. The duration of the intervention will be 12 months; outcomes will be measured at baseline, 6 months, 12 months, and 18 months.ConclusionThis will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving wellbeing of children with CP and their ultra-poor families.

Project description:Background Recent research indicates that intensive rehabilitation tends to be effective for children with cerebral palsy (CP). Intensive Neurophysiological Rehabilitation System (INRS) is a multi-component approach that combines various interventions and addresses different functional goals.. This study aimed to examine the effectiveness of the INRS treatment in children with bilateral CP. Methods In this quasi-randomized controlled study, 48 children with spastic bilateral CP (age 5–12 years, GMFCS Levels I-IV, MACS Levels I-IV) were assigned to an experimental or control group in order they have been enrolled. The experimental group underwent INRS treatment in the tertiary care facility for about four hours daily for ten days and continued routine home treatment for four weeks. After the first evaluation, participants from the control group stayed on the waiting list for four weeks receiving home treatment and then starting the INRS treatment. Thereby, all participants were assessed three times. The primary outcome measure was a Gross Motor Function Measure 66 Item Set (GMFM). The secondary outcome measures included the Jebsen-Taylor Hand Function test, Box and Blocks test, ABILHAND-Kids Questionnaire, Self-care and Mobility domain of the Pediatric Evaluation of Disability Inventory, and the ankle dorsiflexion passive range of motion. Results There was a statistically significant increase in the GMFM score after the INRS treatment in both the experimental group (mean difference (MD) 2.0, P < 0.01) and control group (MD 1.5, P < 0.05), with a large size effect (partial eta squared (η2) = 0.21 and η2 = 0.14). The mean difference between groups during the first study period was 2.89 points (p < 0.01) in the GMFM score with a medium effect size (η2 = 0.12). Statistically significant superiority of the INRS treatment over home treatment was also obtained by Jebsen-Taylor Hand Function Test and the Box and Blocks Test in both dominant and non-dominant hands. Conclusions The study indicates that the INRS treatment can be beneficial for improving both gross motor functions and hand function in children with bilateral CP. Further longitudinal studies are required to evaluate the effects of the INRS treatment on the participation level of children with CP. Trial registration The study protocol was registered on ClinicalTrials.gov under the identifier: NCT04093180 on 17/09/2019.

Project description:ObjectiveThe objective of this study was to assess the rehabilitation status and factors associated with rehabilitation service utilisation among children with cerebral palsy (CP) in Bangladesh.Materials and methodsThis is a population-based surveillance study conducted among children with CP registered in the Bangladesh CP Register (BCPR), the first population-based register of children with CP aged <18 years (y) in Bangladesh. Children with CP were identified from the community using the key informant method and underwent a detailed neurodevelopmental assessment. Socio-demographic, clinical and rehabilitation status were documented. Unadjusted and adjusted analyses with a 95% confidence interval (CI) were used to identify potential predictors of rehabilitation service uptake.ResultsBetween January 2015 and December 2019, 2852 children with CP were registered in the BCPR (mean (standard deviation, SD) age: 7 y 8 months (mo) (4 y 7 mo), 38.5% female). Of these, 50.2% had received rehabilitation services; physiotherapy was the most common type of service (90.0%). The mean (SD) age at commencement of rehabilitation services was 3 y 10 mo (3 y 1 mo). The odds of not receiving rehabilitation was significantly higher among female children (adjusted odds ratio (aOR) 1.3 [95% CI: 1.0-1.7], children whose mothers were illiterate and primary level completed (aOR 2.1 [95% CI: 1.4-3.1] and aOR 1.5 [95% CI: 1.1-2.1], respectively), fathers were illiterate (aOR 1.9 [95% CI: 1.3-2.8]), had a monthly family income ~US$ 59-118 (aOR: 1.8 [95% CI: 1.2-2.6]), had hearing impairment (aOR: 2.3 [95% CI: 1.5-3.5]) and motor severity (i.e. Gross Motor Function Classification System level III (aOR: 0.6 [95% CI: 0.3-0.9]) and level V (aOR: 0.4 [95% CI: 0.2-0.7])).ConclusionsRehabilitation status was poor among the majority of the children with CP in the BCPR cohort, limiting their opportunities for functional improvement. A community-based rehabilitation model focusing on socio-demographic and clinical characteristics should be a public health priority in Bangladesh.

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Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol.

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Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol.

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