How Do Adults With Cerebral Palsy Perceive Their Botulinum Toxin Treatment During Childhood ?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Treatment experience
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Adults with cerebral pasly previously treated with botulinum toxin
干预措施: Patient-Reported Outcome Measures (Other)
结局指标
主要结局
Treatment experience
时间窗: 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.
次要结局
- Coping Strategies BRIEF-Cope Scale(At enrollment)