Childhood Toxin Perception Survey

NCT07377201 | Recruiting

• 2 other identifiers: 2025_09_PERTOXE_RIPH32025-A01186-43
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coping Strategies BRIEF-Cope Scale

  At enrollment

Study Arms (1)

Adults with cerebral pasly previously treated with botulinum toxin

Other: Patient-Reported Outcome Measures

Interventions

Patient-Reported Outcome Measures OTHER

Participants will complete questionnaires regarding their perception of childhood botulinum toxin injections and their current coping strategies. No new medical treatment is administered.

Adults with cerebral pasly previously treated with botulinum toxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with cerebral palsy who experienced botulinum treatment during childhood

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CMCR des Massues

Lyon, 69005, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Dr Emmanuelle Chaleat-Valayer

CONTACT

+33 4 72 38 48 58; emmanuelle.chaleat-valayer@croix-rouge.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)