The STAP-study: The (cost) effectiveness of custom made orthotic insoles in the treatment for plantar fasciopathy in general practice and sports medicine: design of a randomized controlled trial.

BACKGROUND: Plantar fasciopathy is a common cause of foot pain, accounting for 11 to 15% of all foot symptoms requiring professional care in adults. Although many patients have complete resolution of symptoms within 12 months, many patients wish to reduce this period as much as possible. Orthotic devices are a frequently applied option of treatment in daily practice, despite a lack of evidence on the effectiveness. Therefore, the objective is to study the (cost)-effectiveness of custom made insoles by a podiatrist, compared to placebo insoles and usual care in patients with plantar fasciopathy in general practice and sports medicine clinics. METHOD/DESIGN: This study is a multi-center three-armed participant and assessor-blinded randomized controlled trial with 6-months follow-up. Patients with plantar fasciopathy, with a minimum duration of complaints of 2 weeks and aged between 18 and 65, who visit their general practitioner or sport physician are eligible for inclusion. A total of 185 patients will be randomized into three parallel groups. One group will receive usual care by the general practitioner or sports physician alone, one group will be referred to a podiatrist and will receive a custom made insole, and one group will be referred to a podiatrist and will receive a placebo insole. The primary outcome will be the change from baseline to 12 weeks follow-up in pain severity at rest and during activity on a 0-10 numerical rating scale (NRS). Secondary outcomes include foot function (according to the Foot Function Index) at 6, 12 and 26 weeks, recovery (7-point Likert) at 6, 12 and 26 weeks, pain at rest and during activity (NRS) at 6 and 26 weeks and cost-effectiveness of the intervention at 26-weeks. Measurements will take place at baseline and at, 2, 4, 6, 12 and 26 weeks of follow-up. DISCUSSION: The treatment of plantar fasciopathy is a challenge for health care professionals. Orthotic devices are frequently applied, despite a lack of evidence of the effectiveness on patient reported outcome. The results of this randomized controlled trial will improve the evidence base for treating this troublesome condition in daily practice. TRIAL REGISTRATION: Dutch Trial Registration: NTR5346 . Date of registration: August 5(th) 2015.

Parents' experiences with physical and occupational therapy for their young child with cerebral palsy: a mixed studies review.

Understanding the experiences of parents with their child's intervention might help meet the needs of parents and, subsequently get them engaged in their child's intervention. As parents' early beliefs regarding their child's intervention has consequences for treatment participation, it is important to understand these parental perspectives. The aim of this mixed studies review was to give an overview of the experiences and related factors of parents of young children (0-5 years of age) with cerebral palsy in relation to the physical and/or occupational therapy of their child in a rehabilitation setting. The literature was searched systematically for qualitative and quantitative studies published between January 1990 and July 2011. Inclusion criteria were (1) the study population consisted of parents of children with cerebral palsy, with at least 25% of children under the age of five; (2) children had received physical and/or occupational therapy in a rehabilitation setting; and (3) the experiences of the parents with their child's therapy were addressed. Data were synthesized with the framework synthesis method resulting in a conceptual framework describing the factors that are related to the parents' experiences with their child's interventions. A total of 13 studies (eight qualitative and five quantitative) were included and evaluated. Parents expressed various aspects in context, process and outcomes when asked about their experiences with their child's intervention. They had different needs over time and needed time to build a collaborative relationship with their child's therapists. The proposed framework acknowledges the various aspects in context, process and outcomes that parents reported when asked about their experiences. Knowing this, the importance of the broader context of the child in a family should be acknowledged; realizing the impact that the demands of daily life, supports and resources provided to parents, attitudes in the community and culture have on parental experiences.