Childhood Toxin Perception Survey

Official title

How Do Adults With Cerebral Palsy Perceive Their Botulinum Toxin Treatment During Childhood ?

Overview

Context: Most medical and surgical interventions for individuals with Cerebral Palsy (CP)-such as botulinum toxin injections, orthopedic surgery, and rehabilitation-occur during childhood. While these treatments are costly and resource-intensive, there is a significant lack of long-term data regarding their effectiveness in adulthood. Furthermore, the perspective of adult patients on the care they received as children is rarely documented. Understanding this "patient-centered" perspective is vital, as care aligned with an individual's values is proven to result in higher satisfaction and better health outcomes. Problem Statement While botulinum toxin (BTX) has been the gold standard for treating focal spasticity since 2009, it is an iterative (repeated) treatment that can involve procedure-induced pain. At present, there is limited knowledge about how adults with CP perceive the long-term impact of childhood vaccinations. The emotional and physical burden of repeated treatments during development is also not well understood, as are the coping strategies developed by these individuals to manage the stress and pain associated with long-term medical care. Objectives The PERTOXE study is a prospective study designed to explore the transition from childhood care to adult life for individuals with CP. Its primary goals are: Perception of Care: To evaluate how adults with CP perceive the effectiveness and impact of the botulinum toxin injections they received during childhood. Lived Experience: To document the subjective experience of treatment, including induced pain and the quality of communication with healthcare providers. Coping Mechanisms: To explore the "coping strategies" these individuals use to face stressful medical events and chronic functional decline. Significance As the lifespan of individuals with CP increases, understanding long-term outcomes is a research priority. By collecting data from adults, this study aims to improve current pediatric practices, ensuring that childhood interventions better support a high quality of life, functional maintenance, and psychological well-being in adulthood.

Interventions

• Other Patient-Reported Outcome Measures
  Participants will complete questionnaires regarding their perception of childhood botulinum toxin injections and their current coping strategies. No new medical treatment is administered.

Primary outcome measures

• Treatment experience [Time frame: At enrollment]

Secondary outcome measures (1)

• Coping Strategies BRIEF-Cope Scale [Time frame: At enrollment]

Eligibility criteria

Inclusion criteria

• Participants aged 18 years or older
• Diagnosed with cerebral palsy
• Received repeated toxin injections during childhood (> 2 series of injections)
• Agreeing to complete the questionnaire
• Possessing sufficient cognitive abilities, particularly in terms of reading comprehension and oral comprehension (even if someone had to physically assist them in responding)
• All levels of the GMFCS classification 1 to 5

Exclusion criteria

• Individuals who do not meet the above criteria, as confirmed by the statements in Part 1 of the survey, will be automatically excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• CMCR des Massues — Lyon

Identifiers

NCT: NCT07377201 · 2025_09_PERTOXE_RIPH3 · 2025-A01186-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗