Background: Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions.Methods/design: The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter.Discussion: Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia.Trial registration: Number Dutch Trial registration (Nederlands Trial Register): NTR3437.
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Background: Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. Objective: Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. Methods: This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. Results: The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. Conclusions: All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
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BackgroundEarly Childhood Education and Care (ECEC) teachers at urban preschools are potential key figures to promote healthy behaviours in disadvantaged young children and to engage parents in lifestyle-related topics. An ECEC teacher-parent partnership regarding healthy behaviours may support parents and stimulate their children’s development. However, it is not an easy task to establish such a collaboration and ECEC teachers need tools to communicate with parents about lifestyle-related topics. This paper describes the study protocol of a preschool-based intervention (CO-HEALTHY) to promote an ECEC teacher-parent partnership regarding healthy eating, physical (in)activity and sleeping behaviours in young children.MethodsA cluster randomised controlled trial will be performed at preschools in Amsterdam, the Netherlands. Preschools will be randomly allocated to an intervention or control group. The intervention consists of a toolkit with 10 parent-child activities and associated training for ECEC teachers. The activities were composed using the Intervention Mapping protocol. At intervention preschools, ECEC teachers will carry out the activities during standard contact moments. Parents will receive associated intervention materials and will be encouraged to perform similar parent-child activities at home. At control preschools, the toolkit and training will not be implemented. The primary outcome will be the teacher- and parent-reported partnership regarding healthy eating, physical (in)activity and sleeping behaviours in young children. The perceived partnership will be assessed by a questionnaire at baseline and at 6 months. In addition, short interviews with ECEC teachers will be held. Secondary outcomes include the knowledge, attitude, food- and activity-related practices of ECEC teachers and parents. Furthermore, children’s eating, physical (in)activity and sleeping behaviours, and weight development will be assessed. A process evaluation of the intervention will be made.DiscussionThe intervention aims to provide a practical tool for ECEC teachers at urban preschools to promote an ECEC teacher-parent partnership regarding a healthy lifestyle in young children.Trial registrationNetherlands Trial Register (NTR): NL8883. Date registered: September 8, 2020.
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