A Single Case Study to Explore the Impact of Community-based Rebound Therapy on Chest Health Outcomes in School Aged Children and Young People With Neurodisability and Respiratory Issues.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Change in caregiver-reported respiratory symptoms between week 0, 6, 12 and week 18
研究概览
简要总结
Background:
Respiratory illness is the most common reason to attend primary and hospital care in children with neurodisability, accruing significant healthcare costs. Moreover, it remains the primary cause of death in this population. Exercise plays an important role in the prevention and management of respiratory illness in children with neurodisability. Rebound therapy is a popular form of therapeutic exercise using trampolines to facilitate movement. It is highly accessible for children with complex neurodisabilities and has been shown to improve muscle tone, balance, sitting posture, behaviour and quality of life. Additional chest health benefits have been observed in other populations, but has yet to be established in children with neurodisability.
Aim:
This clinical study seeks to explore the impact of community-based rebound therapy on chest health outcomes in school-aged children and young people with complex neurodisability and respiratory issues.
Method:
A single case study ABA design, inviting 4-6 children with neurodisability and respiratory issues to participate. The study will comprise of:
Phase A: 6-week observational baseline measures alongside usual care Phase B: 6-week of rebound therapy, delivered twice weekly alongside usual care Phase A: 6-week observational follow up measures alongside usual care.
Measurements:
- Chest health parameters, measured using respiratory rate, cough frequency, time taken to complete chest care, hospital days, emergency days and primary care consultation days
- Caregiver-reported chest health, measured using the Respiratory Questionnaire for Children with Neurological Impairment questionnaire.
- Caregiver reported quality of life, measured using the CPCHILD Questionnaire and an optional exit interview at week 18 of the study
- Posture will be measured using the Chailey Levels of Ability Scale.
- Adverse Events, measured through safety monitoring of new symptoms, worsening symptoms, hospital days, emergency department days and primary consultation days.
- Adherence, measured through % attendance to 12 rebound sessions.
Data Analysis:
For each single case study, serial data will be subjected to within-phase (A) analysis of stability criterion and across phase (AB) analysis. Single outcome measure data will be plotted alongside serial data findings, providing visual analysis and interpretation of trends. The exit interview will provide textual data that will be subject to thematic analysis methods.
Anticipated Results:
Results will provide early proof of concept data informing the short term effects of exercise-based rebound therapy intervention on chest health, posture and quality of life for children with complex neurodisabilities.
A composite of passive respiratory clinical measurements and participant/caregiver-reported outcomes will be proposed, implementing a combination of serial and single measurements to inform feasibility of future hypothesis testing research.
The close monitoring of adverse events and adherence will inform safety of intervention prescribed and feasibility of delivering intervention to children with complex neurodisabilities and respiratory impairment.
详细描述
This study protocol seeks to explore the impact of community-based rebound therapy on chest health outcomes in school-aged children and young people with complex neurodisability and respiratory issues.
Neurodisability represents one of the largest populations of childhood disability in the UK, defined as a group of conditions associated with impairment of the nervous system. Within this population, respiratory illness is the most common reason to attend primary care consultation, emergency hospital admission and intensive care, accruing significant healthcare costs. Moreover, it remains the primary cause of death, accounting for 51% of cases in children with cerebral palsy.
Chronic respiratory impairments within paediatric neurodisability demand long-term management beyond acute transitory exacerbation, directing attention to prevention and community-based management of respiratory disease. A recent consensus study highlights the importance of optimising physical activity and fitness, postural management and airway clearance in this population, although evidence is limited by lack of comparison groups and good outcome measures. A recent Cochrane review identifies a wide diversity of anecdotally beneficial treatments to support respiratory health within this population of interest, but recognises no 'gold standard' non-pharmaceutical intervention consensus, limited by few and poor-quality studies. However, this body of available literature offers hypothesis generating findings, informing a wide scope for future research into preventing and managing respiratory impairment in children with neurodisability.
Exercise has been identified as a key intervention in the prevention and management of respiratory disease in children with neurodisability. Rebound therapy is a popular form of exercise established in UK educational settings and uses trampolines to provide highly accessible therapeutic exercise to children with moderate to severe complex needs where participation in exercise is otherwise limited. Studies have found rebound therapy to improve participation, muscle tone, and balance, sitting position, behaviour and quality of life in children with neurodisability and features as an important component of care standards for people with learning disability.
Additional respiratory benefits of rebound therapy have also been established in children with cystic fibrosis. Yet, within the population of interest, claims have not been thoroughly examined. There is some evidence to suggest rebound therapy could be advantageous for children with moderate to severe neurodisability, who cannot actively participate in airway clearance techniques and those with a weak cough. Small scale studies indicate improved lung volumes through movement, vocalisation and laughing and imitation of percussion and vibration techniques through the bounce of the trampoline. This raises hypothesis generating evidence that demands further research to establish the effects of this highly accessible, multi-beneficial form of exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >4 years up to <16years
- •Access to a caregiver in a position of main custody, capable of giving consent on the participant's behalf
- •Access to a caregiver in a position of main custody who is able to consent to also participate in the study
- •Accesses full time education
- •Clinical diagnosis of neurodisability
- •Physical impairment Gross Motor Function Classification Scale level 3-5 defined as: (Level 3): Walks with aids. Uses wheelchair for long distances; (Level 4): Self mobility with powered mobility; (Level 5): Severely limited, unable to lift head and trunk or use powered mobility due to other comorbidities like vision impairment.
- •Swallow impairment Eating Drinking Ability Classification Scale Level 3-5, defined as (Level 3): Eats and drinks with some limitations to safety; maybe limitations to efficiency; (Level 4): Eats and drinks with significant limitations to safety; (Level 5): Unable to eat or drink safely - tube feeding may be considered to provide nutrition
- •Symptoms of respiratory impairment, experienced at least once a week, defined as one or more of the following: (1) Noisy breathing (wheezy, gurgling, rattily etc.); (2) Weak/poor cough; (3) Difficulty clearing secretions AND a history of a chest infection in the past 3 years requiring medication.
- •Risk assessment of safe access to educational setting
- •Risk assessment of contraindications and care factors for rebound therapy
排除标准
- •Children diagnosed with a progressive neurological presentation, including muscular dystrophies.
- •Children with a confirmed absolute contraindication that will determine the participant unsuitable to participate in rebound therapy. These include: (1)Cranio-vertebral Instability (including Atlanto-Axial Instability & Atlanto-Occipital Instability); (2) Detatching retina (s) or repaired retina (s); (3) Pregnancy; (4) Brittle bones; (5) Dwarfism; (6) Spinal rodding.
结局指标
主要结局
Change in caregiver-reported respiratory symptoms between week 0, 6, 12 and week 18
时间窗: Proposed Measurement point: week 0, 6, 12, and 18.
Self/proxy reported respiratory symptoms in the last month, using the Respiratory Questionnaire For Children with Neurological Impairment
次要结局
- Overall Intervention Adherence(Proposed Measurement points: serial weekly measurements from week 6-12.)
- Change in Caregiver Priorities & Child Health Index of Life with Disabilities questionnaire(Proposed Measurement points: week 0, 6, 12, 18)
- Change in Clinical Respiratory Observations(Proposed Measurement points: serial weekly measurements from week 0-18.)
- Change in self-reported change in respiratory management care plan(Proposed Measurement points: serial weekly measurements from week 0-18.)
- Number and category of (Serious) Adverse Events ((S)AE)(Proposed Measurement points: serial weekly measurements from week 0-18.)
- Change in Chailey Levels of Ability(Proposed Measurement points: week 0, 6, 12, 18)
- Change in self-reported general health(Proposed Measurement points: serial weekly measurements from week 0-18.)
- Change in self-reported change in postural management care plan(Proposed Measurement points: serial weekly measurements from week 0-18.)
研究者
Jon Marsden
Professor of Rehabilitation
University of Plymouth