Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old
Condition: Motor Disorders
MeSH terms: Motor Disorders
Study type: Interventional

Summary: 
      Background: Many children (about 1 child out of 20) have motor delays that are sometimes seen
      as "minor" and are not immediately explained by a specific diagnosis. These children are
      often underserved by existing health and rehabilitation services even though they are at risk
      of developing important negative outcomes in the long run. The most recent scientific
      evidence indicates that motor delays can be effectively addressed via early interventions
      supporting families and stimulating the child's development. Some researchers have proposed
      that such interventions could be efficiently and conveniently delivered online but no
      patient-centred, interactive online intervention has been formally trialed in Canada for
      children with motor delay and their families.

      Objectives: The goal of this study is to determine whether an online intervention can support
      families of children with motor delay. This study will determine whether the online
      intervention can improve the child's motor skills and parental self-efficacy, decrease
      parental stress, as well as increase the quality of life of both the parent and child.

      Description: The investigators will recruit 118 families of children with motor delay, 3 to 8
      years of age, who are not yet receiving public rehabilitation services. These children will
      have been identified as at-risk of motor difficulties by their parents who will have
      completed a self-reported screening test for motor difficulties. Families will be randomly
      assigned to one of two groups: 1) control group (usual care) or 2) intervention group (access
      to the WECARE web platform, including one-on-one virtual meetings with health professionals,
      group and private discussions, verified resources). This study, conducted in Quebec, will be
      led by researchers, telerehabilitation experts, decision makers and patient advocates.

      Relevance: This study will evaluate an innovative, convenient and accessible intervention
      providing assistance for an important yet underserved population of children and their
      families.
    

Detailed description: 
      Detailed objectives:

      The overarching goal of this patient-centred, mixed-methods, randomized, innovative pragmatic
      trial is to evaluate the effectiveness of the WECARE intervention for children aged 3-8 years
      with motor difficulties living in Quebec. The primary objective is to evaluate, in comparison
      to usual care management, the effectiveness of the WECARE program for improving the child's
      performance on parent-identified motor functioning targets. Secondary objective is to
      evaluate the effect of the intervention on children's functioning, parental self-efficacy,
      parental stress, as well as the quality of life of both the parent and child.

      Detailed design: A patient-centred innovative pragmatic randomized controlled trial
      documenting real-world effectiveness of the WECARE intervention, offered to families of
      children with motor difficulties living in Quebec and receiving no public rehabilitation
      services. A primary respondent (i.e., parent or legal guardian) will be identified but the
      whole family will have access to the WECARE intervention.

      This trial was designed according to the latest guidelines on pragmatic trials, using the
      gold-standard CONSORT guidelines, and the TElehealth in CHronic Disease (TECH) conceptual
      framework.
    

Intervention name(s): WECARE web platform
Intervention type(s): Other
Intervention description(s): The WECARE intervention allows families of children with motor difficulties to access rehabilitation therapists. The primary therapist will be an occupational therapist or a physiotherapist who will have one day a week to deliver the intervention. The therapist will act as case manager to connect families with community-based services available in their region and work, according to a transdisciplinary model, with an interdisciplinary team on a needs-based basis. Patient engagement with the therapists and in the WECARE intervention will be ensured by the collaborative coaching approach used by therapists to attain meaningful motor outcomes, as selected by the primary respondent.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The family will be the unit of randomization. A web-based randomization service will allocate participants to either usual care or the WECARE intervention (1:1). To ensure equal distribution of participants between arms, permutated blocks of variable (2:4:6) size will be generated. No stratification or minimization strategies will be used. Participants will be invited to set their motor-performance goals before allocation to avoid the influence of the allocation group on goals selection.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tele-intervention; Motor delay; Child; Parental support