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Ayer — Abril 21st 2026Tus fuentes RSS

Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) - protocol of a feasibility pilot randomised controlled trial

Por: Guzzetta · A. · Bancale · A. · Bedoshvili · A. · Bosanquet · M. · Chorna · O. · Corsi · G. · Del Secco · S. · Elliott · C. · Fiori · S. · Fripp · J. · Gole · G. A. · Gordon · A. · Harpster · K. · Hunt · R. W. · Leishman · S. · Mori · R. · Morgan · C. · Novak · I. · Pagnozzi · A. M. · Pannek
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.

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HOPPER: implementation of a home-based prehabilitation programme with app support for patients undergoing colorectal cancer surgery--a study protocol

Por: Pannekoek · A. · Timmers · T. · Kool · R. B. · Schreurs · H.
Background

Preoperative prehabilitation programmes for patients with colorectal cancer have been shown to reduce complications and hospital length of stay. However, supervised weekly physiotherapy is expensive and timeconsuming for both healthcare professionals and patients, leading to suboptimal implementation of prehabilitation programmes. A previous study demonstrated that offering home-based prehabilitation through an app is feasible and leads to outcomes comparable to supervised prehabilitation programmes. This study was conducted at a single hospital. To expand this promising modality nationwide, it is essential to identify key implementation determinants. We therefore initiated this multicentre study involving a more diverse and heterogeneous patient population. The findings of this study will provide valuable input for scaling strategies for prehabilitation programmes in the Netherlands and beyond.

Methods

In this prospective multicentre cohort study, approximately 300 patients with colorectal cancer scheduled for curative surgery will be enrolled over 12 months. The study adopts a hybrid type 3 design, reporting clinical outcomes while exploring implementation-related factors. Five hospitals with varied profiles (academic, non-academic teaching and general hospitals) and geographical locations (urban and rural, high and low socioeconomic areas) are participating. The primary endpoint is the identification of barriers and facilitators, using both qualitative (interviews) and quantitative (user statistics, questionnaires) data from stakeholders. Secondary endpoints include fitness and clinical outcomes such as complications and mortality.

Ethics and dissemination

This study was approved by the METC (Medisch Ethische Toetsings Commissie / Dutch Medical Ethics Committee) and was established not to apply to the Medical Research Involving Human Subjects Act (WMO / Wet Medisch Wetenschappelijk Onderzoek met mensen); submission was 21 April 2025. The app is proven safe and feasible in earlier studies and is CE certified (Conformité Européenne). Informed consent will be obtained from all patients (Supplement 1). Adverse events will be monitored and reported. Only researchers will have access to the final dataset. Results will be disseminated through publications, patient group briefings and implementation feedback to healthcare workers. Plans for sharing deidentified individual clinical trial participant-level data consist of quotes from interviews held on stakeholders. This study protocol adheres to the SPIRIT guidelines.

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