Childhood Toxin Perception Survey (PERTOXE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Other: Patient-Reported Outcome Measures

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dr Emmanuelle Chaleat-Valayer; Phone Number: +33 4 72 38 48 58; Email: emmanuelle.chaleat-valayer@croix-rouge.fr

Study Locations

• France
  • Lyon, France, 69005
    • Recruiting
    • CMCR des Massues
    • Contact: Julie Rozaire; Phone Number: +33 04 72 38 11 43; Email: julie.rozaire@croix-rouge.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with cerebral palsy who experienced botulinum treatment during childhood

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with cerebral pasly previously treated with botulinum toxin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment experience	This assessment is not based on a single scale, but on a series of multidimensional questions exploring the patient's memories on the treatment they received in childhood: Induced pain: Assessment of the pain relief methods used (MEOPA, EMLA, anaesthesia, etc.).; Communication and preparation: Questions about the quality of preparation, how well the medical team listened, the consent process, and understanding of the purpose of the treatment.; Overall satisfaction: Use of satisfaction scales from 0 to 10 (where 0 = 'not at all satisfied' and 10 = 'perfectly satisfied') to rate effectiveness, conditions and communication.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Strategies BRIEF-Cope Scale	Use of the French version of the BRIEF-Cope (28 items) to identify the specific coping mechanisms (e.g., active coping, denial, humor, or substance use) used by adults with Cerebral Palsy when facing stressful events. Respondents use a 4-point scale to answer each statement: 1 - not at all; 2 - a little; 3 - a lot; 4 - very much. The responses obtained are added up for each scale. Higher scores on a scale indicate increased use of that coping mechanism.	At enrollment

Collaborators and Investigators

• Sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Economics and Organizations; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surveys and Questionnaires; Health Planning; Health Care Surveys; Health Services Research; Patient Outcome Assessment; Patient Reported Outcome Measures
• Other Study ID Numbers: 2025_09_PERTOXE_RIPH3; 2025-A01186-43 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No