NCT07351695

Brief Summary

Children with cerebral palsy are at increased risk of malnutrition due to motor impairment, feeding difficulties, and chronic health problems. Accurate assessment of nutritional status in this population can be challenging, particularly when standard anthropometric measurements are difficult to obtain. This observational study aims to evaluate nutritional status in children with cerebral palsy using the mid-upper arm circumference Z-score (MUACZ) and to examine its relationship with functional severity levels. Anthropometric measurements and clinical data will be collected during routine outpatient visits. Nutritional status will be classified using predefined reference standards, and associations with motor and feeding function classifications will be analyzed. The findings of this study are expected to contribute to a better understanding of practical approaches for nutritional assessment in children with cerebral palsy across different ages and functional levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 10, 2026

Last Update Submit

January 10, 2026

Conditions

Keywords

Cerebral palsyChild nutrition disordersAnthropometryBody Mass IndexFeeding and Eating DisordersMalnutritionMotor ActivityNutritional Status

Outcome Measures

Primary Outcomes (1)

  • Prevalence of undernutrition in children with cerebral palsy

    Undernutrition status will be determined using predefined anthropometric Z-score criteria. Undernutrition is defined as the presence of wasting (body mass index-for-age Z-score ≤ -2) and/or stunting (height-for-age Z-score ≤ -2), based on standardized growth references.

    At study enrollment (single assessment during routine outpatient visit).

Secondary Outcomes (3)

  • Distribution of nutritional status across functional severity levels

    At study enrollment.

  • Association between MUACZ and functional severity classifications

    At study enrollment.

  • Performance of MUACZ in identifying undernutrition

    At study enrollment.

Study Arms (1)

Cerebral Palsy

This observational study includes a single cohort of pediatric patients with a confirmed diagnosis of cerebral palsy. Participants are enrolled during routine outpatient follow-up visits at a tertiary care center. Within the cohort, participants are categorized according to nutritional status based on predefined anthropometric criteria and according to functional severity using established classification systems. No separate control group is included. Comparisons are performed within the cohort across nutritional status categories and functional severity levels to evaluate distributions and associations.

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of children and adolescents with a confirmed diagnosis of cerebral palsy who are followed at a tertiary referral center. Participants are recruited during routine outpatient follow-up visits and represent a wide spectrum of motor and feeding functional severity. The population includes patients across all levels of gross motor function and eating and drinking ability, allowing evaluation of nutritional status across varying degrees of functional impairment. Anthropometric and clinical data are collected as part of standard care, without any modification to routine clinical management. This population reflects a real-world clinical setting in which nutritional assessment is routinely performed in children with cerebral palsy, including those with severe motor and feeding limitations.

You may qualify if:

  • Children and adolescents with a confirmed diagnosis of cerebral palsy
  • Age between 18 months and 18 years at the time of assessment
  • Attendance at routine outpatient follow-up at the study center during the study period
  • Availability of anthropometric measurements required for nutritional assessment
  • Availability of functional classification using the Gross Motor Function Classification System (GMFCS) and/or the Eating and Drinking Ability Classification System (EDACS)
  • Written informed consent obtained from a parent or legal guardian

You may not qualify if:

  • Presence of acute illness or infection at the time of assessment that could interfere with anthropometric measurements
  • Known genetic syndromes or metabolic disorders affecting growth independently of cerebral palsy
  • Incomplete clinical or anthropometric data preventing classification of nutritional status
  • Previous major surgery or hospitalization within a period that could significantly influence nutritional measurements (as determined by the treating clinician)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman Research and Training Hospital

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyChild Nutrition DisordersFeeding and Eating DisordersMalnutritionMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Member

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 20, 2026

Study Start

October 1, 2023

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this study, including demographic variables, anthropometric measurements, and functional classification data.

Shared Documents
ANALYTIC CODE
Time Frame
Beginning 6 months after publication of the primary results and ending 5 years following publication.
Access Criteria
Individual participant data will be made available to qualified researchers upon reasonable request. Requests will be reviewed by the corresponding author and require approval from the relevant institutional and/or ethics committees, where applicable. Data will be shared in de-identified form to protect participant privacy, and access may require a data use agreement specifying the intended use of the data.

Locations