{
  "abstract": "Introduction Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).Methods and analysis A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.Ethics and dissemination The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.Trial registration number ACTRN12618000932268.",
  "authors": [
    {
      "affiliations": [
        "Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy",
        "Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy"
      ],
      "name": "Andrea Guzzetta"
    },
    {
      "affiliations": [
        "Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy"
      ],
      "name": "Ada Bancale"
    },
    {
      "affiliations": [
        "David Tvildiani Medical University, Tbilisi, Georgia",
        "Bokeria Neurodevelopmental Center, Tbilisi, Georgia"
      ],
      "name": "Anna Bedoshvili"
    },
    {
      "affiliations": [
        "Department of Health and Wellbeing, Townsville University Hospital, Douglas, Queensland, Australia",
        "School of Medicine, University of Queensland, Herston, Queensland, Australia",
        "School of Medicine and Dentistry, James Cook University, Douglas, Queensland, Australia"
      ],
      "name": "Margot Bosanquet"
    },
    {
      "affiliations": [
        "Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy"
      ],
      "name": "Olena Chorna"
    },
    {
      "affiliations": [
        "Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy"
      ],
      "name": "Giulia Corsi"
    },
    {
      "affiliations": [
        "Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy",
        "NEUROFARBA, University of Florence, Florence, Italy"
      ],
      "name": "Sabrina Del Secco"
    },
    {
      "affiliations": [
        "School of Allied Health, Curtin University, Perth, Western Australia, Australia",
        "Telethon Kids Institute, Nedlands, Western Australia, Australia"
      ],
      "name": "Catherine Elliott"
    },
    {
      "affiliations": [
        "NEUROFARBA, University of Florence, Florence, Italy",
        "Neuroscience and Medical Genetics Department, Meyer Children’s Hospital IRCCS, Florence, Italy"
      ],
      "name": "Simona Fiori"
    },
    {
      "affiliations": [
        "The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia"
      ],
      "name": "Jurgen Fripp"
    },
    {
      "affiliations": [
        "CHQ Clinical Unit -UQ, Queensland Children's Hospital, Brisbane, Queensland, Australia"
      ],
      "name": "Glen A Gole"
    },
    {
      "affiliations": [
        "Department of Health and Wellbeing, Townsville University Hospital, Douglas, Queensland, Australia",
        "Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Anya Gordon"
    },
    {
      "affiliations": [
        "Occupational Therapy and Physical Therapy, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA",
        "Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA"
      ],
      "name": "Karen Harpster"
    },
    {
      "affiliations": [
        "Paediatrics, Monash University, Clayton, Victoria, Australia"
      ],
      "name": "Rod W Hunt"
    },
    {
      "affiliations": [
        "Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Shaneen Leishman"
    },
    {
      "affiliations": [
        "Physiotherapy, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia"
      ],
      "name": "Rosalie Mori"
    },
    {
      "affiliations": [
        "Cerebral Palsy Alliance Research institute, Specialty of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Catherine Morgan"
    },
    {
      "affiliations": [
        "Cerebral Palsy Alliance Research institute, Specialty of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia",
        "The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia"
      ],
      "name": "Iona Novak"
    },
    {
      "affiliations": [
        "The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia"
      ],
      "name": "Alex Michael Pagnozzi"
    },
    {
      "affiliations": [
        "The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia"
      ],
      "name": "Kerstin Pannek"
    },
    {
      "affiliations": [
        "The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Swetha Sara Philip"
    },
    {
      "affiliations": [
        "Division of Ophthalmology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA",
        "Department of Ophthalmology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA"
      ],
      "name": "Melissa Rice"
    },
    {
      "affiliations": [
        "Paediatric Rehabilitation, Perth Children’s Hospital, Nedlands, Western Australia, Australia",
        "University of Western Australia, Perth, Western Australia, Australia"
      ],
      "name": "Alison Salt"
    },
    {
      "affiliations": [
        "Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Bernadette Shannon"
    },
    {
      "affiliations": [
        "Division of Ophthalmology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA"
      ],
      "name": "Terry Schwartz"
    },
    {
      "affiliations": [
        "David Tvildiani Medical University, Tbilisi, Georgia",
        "Neuroscience Department, M.Iashvili Central Children’s Hospital, Tbilisi, Georgia"
      ],
      "name": "Nana Nino Tatishvili"
    },
    {
      "affiliations": [
        "David Tvildiani Medical University, Tbilisi, Georgia",
        "Bokeria Neurodevelopmental Center, Tbilisi, Georgia"
      ],
      "name": "Sofia Tatishvili"
    },
    {
      "affiliations": [
        "Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Roslyn N Boyd"
    }
  ],
  "title": "Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) – protocol of a feasibility pilot randomised controlled trial",
  "uid": "a01036da-092d-5edd-b7a1-40f653bdb4cf"
}