The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial

Trials. 2019 Jul 10;20(1):417. doi: 10.1186/s13063-019-3527-9.


Background: Cerebral visual impairment (CVI), including perceptual visual dysfunction (PVD), is common in children with cerebral palsy (CP). Inventories of questions relating to practical aspects of visual perception in everyday life, in particular the closed-ended Insight Questions Inventory (IQI), can be used to assess CVI/PVD. Studies linking responses to the inventory with specific visual support strategies, aimed at modifying the child's environment and/or behaviour to minimize the impact of the CVI/PVD, have been piloted. The IQI and tailored strategies have not been used in an African population, nor have they been tested in a controlled trial. This trial will compare the effectiveness of the IQI and linked visual support strategies versus general supportive treatments on the quality of life of children with CVI/PVD and CP through a randomized controlled trial.

Methods/design: This is a prospective, double-blind, parallel-arm, randomized controlled trial. The primary outcome is change in quality of life scores between the two arms of the trial at 6 weeks, assessed using the Paediatric Quality of Life Inventory (PedsQL) generic 4.0 and CP 3.0 module. All children will undergo baseline assessment including the Open Questions Inventory, IQI, PedsQL 3.0, PedsQL 4.0 generic, and the Strengths and Difficulties Questionnaire (SDQ). Eligible children with CP aged 4 years to < 16 years will be stratified and blocked by the age groups 4-9 and 10 to < 16 years and by Gross Motor Function Classification System (GMFCS) levels 1-3 and 4-5. Families in the intervention arm will receive tailored insight visual support strategies and telephone calls during the 6-week trial period. The control arm will receive standard treatment and the intervention after the 6-week trial period. Follow-up interviews will be performed in both arms at 6 weeks with a repeat administration of the PedsQL CP 4.0 and 3.0, the IQI and the SDQ. Secondary outcomes include a change in functional vision.

Discussion: This randomized controlled trial will provide evidence of the effectiveness of this intervention for children with CP in a resource-poor setting.

Trial registration: Pan African Clinical Trials Registration, PACTR201612001886396 . Registered on 3 December 2016.

Keywords: Cerebral palsy; Cerebral visual impairment; Insight Questions Inventory; Paediatric quality of life; Perceptual visual dysfunction; Visual support strategies.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Age Factors
  • Cerebral Palsy / diagnosis
  • Cerebral Palsy / physiopathology
  • Cerebral Palsy / psychology
  • Cerebral Palsy / rehabilitation*
  • Child
  • Child, Preschool
  • Disabled Children / psychology
  • Disabled Children / rehabilitation*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Nigeria
  • Prospective Studies
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Treatment Outcome
  • Vision Disorders / diagnosis
  • Vision Disorders / physiopathology
  • Vision Disorders / psychology
  • Vision Disorders / rehabilitation*
  • Visual Cortex / physiopathology*
  • Visual Perception*
  • Visually Impaired Persons / psychology
  • Visually Impaired Persons / rehabilitation*