| NCT ID | NCT07377201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française |
| Condition | Cerebral Palsy (CP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-02-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07377201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07377201 currently recruiting?
Yes, NCT07377201 is actively recruiting participants. Contact the research team at emmanuelle.chaleat-valayer@croix-rouge.fr for enrollment information.
Where is the NCT07377201 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT07377201 clinical trial?
NCT07377201 is sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. The trial plans to enroll 500 participants.
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