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

Abstract

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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3527-9) contains supplementary material, which is available to authorized users.

What assessments are currently used to investigate and diagnose cerebral visual impairment (CVI) in children? A systematic review

“…The remaining article was a short report discussing validation of the visual skills inventory questionnaire 27 . All other articles reported a visual acuity measurement, 20 (43.5%) reported measuring the participants’ refractive status, 11,20,21,28–44 26 (56.5%) documented that a visual field assessment was conducted 7,11,21,28,31,32,35–38,40–42,44–56 and 26 (56.5%) reported assessment of ocular health 7,11,20–22,28–36,40–44,46,48,51,57–60 . Five (11.1%) articles documented assessment of contrast sensitivity, 21,37,38,42,61 seven (15.6%) reported measuring stereopsis 21,35,37,38,42,48,49 and four (8.9%) articles measured accommodative accuracy 32,40,42,49 …”

“…Of the publications that included neuroimaging results, the majority ( n = 23, 82.1%) were obtained retrospectively from the child’s medical records. Four of the remaining six articles reported use of MRI at the time of assessment; 21,34,47,57 one reported a mixture of all three neuroimaging modalities 29 and one did not specify the type of neuroimaging technique used 42 . This resulted in a considerable amount of missing neuroimaging data and a lack of consistency in the type of neuroimaging assessment undertaken i.e., some participants may have had a CT scan, while others had a MRI scan.…”

“…This resulted in a considerable amount of missing neuroimaging data and a lack of consistency in the type of neuroimaging assessment undertaken i.e., some participants may have had a CT scan, while others had a MRI scan. Five articles did not report which neuroimaging technique had been used, but simply stated that neurological assessments were performed or results were available from medical notes 11,42,49,67,68 …”

Clinical use of the Insight Inventory in cerebral visual impairment and the effectiveness of tailored habilitational strategies

“…In addition, as a pilot study, there was no formal sample size calculation so p ‐values therefore need to be interpreted with caution. A randomized controlled trial is now underway on the basis of the encouraging preliminary results 25 . Future studies need to investigate the impact of the strategies on children’s quality of life, including a comparison group.…”

“…A randomized controlled trial is now underway on the basis of the encouraging preliminary results. 25 Future studies need to investigate the impact of the strategies on children's quality of life, including a comparison group. There may also be room for further refinement or extension of the Inventory and the strategies suggested, to better meet the needs of children aged 12 years and above or children with more complex needs.…”