Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Aug 7:41:101343.
doi: 10.1016/j.conctc.2024.101343. eCollection 2024 Oct.

A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

Ruzha Pancheva  1   2 , Stanka A Fitneva  3 , Rositsa Chamova  1   2 , Dimitar Marinov  1   2 , Albena Toneva  1   2 , Stanislava Hadzhieva  1   2 , Rozalina Braykova  1   2 , Nikoleta Yoncheva  4 , Stefka Tsvetanova  4 , Silviya Nikolova  2   5 , Natalya Usheva  2   5 , Koen Huysentruyt  6 , Karina Dimova  7 , Yana Bocheva  7 , Stanislava Pavlova  8 , Petya Hristanova  8
Affiliations

A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

Ruzha Pancheva et al. Contemp Clin Trials Commun. .

Abstract

Introduction: Children with Cerebral Palsy (CP) encounter substantial nutritional challenges that impair their health and quality of life. Despite the importance of nutrition in managing CP and the recognition of physiological, behavioral, and social causes of malnutrition, research on the effectiveness of individualized nutritional interventions developed and supported by multidisciplinary teams is scarce.

Aim: The study will evaluate the impact of an individualized nutritional intervention developed and supported by a multidisciplinary team on the anthropometric outcomes and overall health of children with CP.

Methods: A single-center, randomized controlled trial, conducted at the Medical University of Varna, Bulgaria, will enroll 100 children aged 2-12 years and diagnosed with CP. Participants will be randomly assigned to either an intervention group, receiving comprehensive structured dietary assessment and individualized nutrition plan developed by a multidisciplinary team of experts, or to a standard care group. Outcomes assessed will focus on anthropometric measures of nutritional status, but also include health outcomes, child development and clinical assessments, and quality of life indicators.

Ethics: Ethical approval for this study has been obtained from the Medical Ethics Committee at the Medical University of Varna (Protocol No. 134 dated 20.07.2023).

Conclusion: This study will assess the benefits of a multidisciplinary, individualized nutritional intervention for children with CP. The findings will have implications for clinical guidelines and interventions aiming to improve their care and quality of life.

Keywords: Cerebral palsy; Individualized; Intervention; Multidisciplinary; Nutrition.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flowchart of study process.
Fig. 2
Fig. 2
Hypothetical form of the results for control group (green) and intervention group (blue). The figure captures the intended change for underweight and overweight children and the intended no change for children with weight in the normal range. (For interpretation of the references to colour in this figure legend, the reader is referred to the Web version of this article.)
Fig. 3
Fig. 3
Required sample size expecting small-to-medium effect of the intervention.
See this image and copyright information in PMC

References

    1. McIntyre S., Goldsmith S., Webb A., Ehlinger V., Hollung S.J., McConnell K., Arnaud C., Smithers‐Sheedy H., Oskoui M., Khandaker G., Himmelmann K. Global prevalence of cerebral palsy: a systematic analysis. Dev. Med. Child Neurol. 2022;64:1494–1506. doi: 10.1111/dmcn.15346. - DOI - PMC - PubMed
    1. Fragale N., Navarre N., Rogers J. In: Cerebral Palsy. Miller F., Bachrach S., Lennon N., O'Neil M., editors. Springer International Publishing; Cham: 2019. General nutrition for children with cerebral palsy; pp. 1–10. - DOI
    1. Jahan I., Sultana R., Muhit M., Akbar D., Karim T., Al Imam M.H., Das M.C., Smithers-Sheedy H., McIntyre S., Badawi N., Khandaker G. Nutrition interventions for children with cerebral palsy in low-and middle-income countries: a scoping review. Nutrients. 2022;14 doi: 10.3390/nu14061211. - DOI - PMC - PubMed
    1. Adams M.S., Khan N.Z., Begum S.A., Wirz S.L., Hesketh T., Pring T.R. Feeding difficulties in children with cerebral palsy: low-cost caregiver training in Dhaka, Bangladesh. Child Care Health Dev. 2012;38:878–888. doi: 10.1111/j.1365-2214.2011.01327.x. - DOI - PubMed
    1. CDC Help children maintain healthy weight [WWW document] Cent. Dis. Control Prev. 2023 https://www.cdc.gov/healthyweight/children/index.html URL.

LinkOut - more resources