Dataset Information

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

ABSTRACT:

Background

Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs).

Objective

To demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP).

Design

Semi-structured interviews were carried out with 20 parents of children with CP and other neurological conditions, asking them to choose between four different trial designs, to talk about noticeable changes in their child's condition and their views about payment for trial treatment.

Setting and participants

The parents interviewed were all members of Cerebra, a charity for 'brain-injured' children and young people. All interviews were carried out at the parents' homes.

Results

Parents had mixed views about possible trial designs; however, a waitlist design which allowed all children eventually to receive the treatment emerged as a clear favourite. Parents did not focus on isolated outcomes, but suggested a range of factors relevant to their child's quality of life. They expressed a clear preference for the costs of treatment to be funded by the trial.

Conclusions

Involvement of parents helped design a trial which was acceptable to families and addressed outcomes that mattered to them. By consulting parents about the design of the research, the subsequent trial achieved excellent recruitment and retention rates.

SUBMITTER: Edwards V

PROVIDER: S-EPMC5060591 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Publications

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

Edwards Vanessa V Wyatt Katrina K Logan Stuart S Britten Nicky N

Health expectations : an international journal of public participation in health care and health policy 20110118 4

<h4>Background</h4>Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs).<h4>Objective</h4>To demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP).<h4>Design</h4>Semi-stru ...[more]

PMID: 21244590

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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:Upper limb (UL) deficits in children with unilateral cerebral palsy (uCP) have traditionally been targeted with motor execution treatment models, such as modified Constraint-Induced Movement Therapy (mCIMT). However, new approaches based on a neurophysiological model such as Action-Observation Training (AOT) may provide new opportunities for enhanced motor learning. The aim of this study is to describe a randomised controlled trial (RCT) protocol investigating the effects of an intensive treatment model, combining mCIMT and AOT compared to mCIMT alone on UL function in children with uCP. Additionally, the role of neurological factors as potential biomarkers of treatment response will be analysed.An evaluator-blinded RCT will be conducted in 42 children aged between 6 and 12 years. Before randomization, children will be stratified according to their House Functional Classification Scale, age and type of corticospinal tract wiring. A 2-week day-camp will be set up in which children receive intensive mCIMT therapy for 6 hours a day on 9 out of 11 consecutive days (54 h) including AOT or control condition (15 h). During AOT, these children watch video sequences showing goal-directed actions and subsequently execute the observed actions with the more impaired UL. The control group performs the same actions after watching computer games without human motion. The primary outcome measure will be the Assisting Hand Assessment. Secondary outcomes comprise clinical assessments across body function, activity and participation level of the International Classification of Function, Disability and Health. Furthermore, to quantitatively evaluate UL movement patterns, a three-dimensional motion analysis will be conducted. UL function will be assessed at baseline, immediately before and after intervention and at 6 months follow up. Brain imaging comprising structural and functional connectivity measures as well as Transcranial Magnetic Stimulation (TMS) to evaluate corticospinal tract wiring will be acquired before the intervention.This paper describes the methodology of an RCT with two main objectives: (1) to evaluate the added value of AOT to mCIMT on UL outcome in children with uCP and (2) to investigate the role of neurological factors as potential biomarkers of treatment response.NCT03256357 registered on 21st August 2017 (retrospectively registered).

Project description:Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy.A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment).This paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy.[clinical trial registration #: NCT00469872].

Project description:Children with cerebral palsy (CP) often show executive function (EF) impairments that are key to quality of life. The aim of this study was to assess whether a home-based computerized intervention program improves executive functions (EFs) compared to usual care. Sixty participants (30 females) with CP (8-12 years old) were paired by age, sex, motor ability, and intelligence quotient score and then randomized to intervention and waitlist control groups. The intervention group received a 12-week home-based computerized EF intervention (5 days/week, 30 min/day, total dose 30 h). Core and higher-order EFs were assessed before, immediately after, and 9 months after completing the intervention. The intervention group performed better than the waitlist control group in the three core EFs (immediately and 9 months after the intervention): inhibitory control (F = 7.58, p = 0.13 and F = 7.85, p = 0.12), working memory (F = 8.34, p = 0.14 and F = 7.55, p = 0.13), and cognitive flexibility (F = 4.87, p = 0.09 and F = 4.19, p = 0.08). No differences were found between the groups in higher-order EFs or EF manifestations in daily life.ConclusionsA home-based computerized EF intervention improved core EFs in children with CP, but further research is needed to identify strategies that allow the transfer of these improvements to everyday life.Trial registrationNCT04025749 retrospectively registered on 19 July 2019.What is known• One in two children with cerebral palsy has an intellectual impairment. Visual perception and executive functions are the most reported specific cognitive deficits. • The majority of interventions for cerebral palsy focus on motor impairments, but only a few randomized controlled trials have explored the effect of interventions on executive functions.What is new• A home-based computerized cognitive intervention can improve the core executive functions of children with cerebral palsy. • Short- and long-term effects on core executive functions have been found.

Project description:Cerebral palsy (CP) is the most common motor disability in childhood (2 to 3 per 1000 live births), and is frequently accompanied by cognitive impairments and behavioural problems. Children with CP are at increased risk of attention deficit disorder with or without hyperactivity (Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD)) including working memory deficits. The primary aim of this study is to evaluate if cognitive training may improve working memory in children with CP.The study is an investigator-blinded, randomized controlled trial with a stepped-wedge design that will include 115 schoolchildren with CP. Eligible for participation are children with CP, aged 7 to 15 years, who are able to follow instructions and handle a computer mouse. Exclusion criteria are the presence of photosensitive epilepsy, Gross Motor Function Classification System (GMFCS) level V (most severe CP) (Phys Ther 80: 974-985, 2000) and severe visual or hearing impairments. Following assessment of eligibility and baseline cognitive assessment the participants will be randomized to either cognitive working memory training or treatment-as-usual ('control group'). The intervention is a computer-based working memory training program consisting of 25 daily sessions to be performed over a 5 to 6-week period at home. A neuropsychological assessment will be performed before and 4 to 6 weeks after completed training. When the latter assessment has been completed in the intervention group, the 'control group' will start on the same training program. Both groups will meet for a final neuropsychological assessment six months after completed training by an examiner unaware of group adherence.There is limited evidence for the effect of most interventions in children with CP, and evidence is completely lacking for interventions aiming to improve deficits in cognition, learning and behaviour. The proposed multicenter study, will bring forth comprehensive information about cognitive, neuropsychological, and daily-life functioning in children with CP aged between 7 and 15 years. In addition, the study will be the first to evaluate the effects of an intervention method to improve working memory in children with CP. If successful, computer-based working memory training may represent an efficient and cost-effective intervention for this group of children.ClinicalTrials.gov Identifier: NCT02119364.

Dataset Information

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

Background

Objective

Design

Setting and participants

Results

Conclusions

Publications

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

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