Cerebral Palsy (CP)PERTOXENCT07377201
Childhood Toxin Perception Survey
An observational study of Cerebral Palsy (CP), run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Patient-Reported Outcome Measures
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with cerebral palsy who experienced botulinum treatment during childhood
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CMCR des Massues
Lyon, 69005
Julie Rozaire, +33 04 72 38 11 43, julie.rozaire@croix-rouge.fr
About this study
Official title: 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.
Read more
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)
- Being tested
- Patient-Reported Outcome Measures
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcome MeasuresOther
Participants will complete questionnaires regarding their perception of childhood botulinum toxin injections and their current coping strategies. No new medical treatment is administered.
| Study group | Role | What they receive |
|---|---|---|
| Adults with cerebral pasly previously treated with botulinum toxin | Not described Receives: Other: Patient-Reported Outcome Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (1)
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377201
- Sponsor's protocol ID
- 2025_09_PERTOXE_RIPH3
- Other IDs
- 2025-A01186-43
- Acronym
- PERTOXE
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Do Adults With Cerebral Palsy Perceive Their Botulinum Toxin Treatment During Childhood ?
- ClinicalTrials.gov ID
- NCT07377201
- Acronym / sponsor ID
- PERTOXE / 2025_09_PERTOXE_RIPH3
- Conditions
- Cerebral Palsy (CP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with cerebral pasly previously treated with botulinum toxin | – | Other: Patient-Reported Outcome Measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with cerebral palsy who experienced botulinum treatment during childhood
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Reported Outcome MeasuresParticipants will complete questionnaires regarding their perception of childhood botulinum toxin injections and their current coping strategies. No new medical treatment is administered. | Other | Adults with cerebral pasly previously treated with botulinum toxin |
Primary outcome
Treatment experience
Time frame: At enrollment
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.
1 secondary outcome
Coping Strategies BRIEF-Cope Scale
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP), run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Emmanuelle Chaleat-Valayer (+33 4 72 38 48 58, emmanuelle.chaleat-valayer@croix-rouge.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment experience (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.