Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.
Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
Health Technol Assess. 2018 Sep;22(50):1-232. doi: 10.3310/hta22500.
Standing frames are recommended as part of postural management for young people with cerebral palsy (CP) Gross Motor Function Classification System (GMFCS) level IV or V. They may have a variety of benefits, including improving bone mineral density, gastrointestinal function and social participation. The NHS needs to know if these benefits are real, given the cost implications of use and the reported negative effects (e.g. pain). The lack of evidence for the clinical effectiveness of standing frames demonstrates the need for evaluative research.
OBJECTIVE(S): The aim of the study was to explore the acceptability of a future trial to determine the clinical effectiveness of standing frames.
A sequential mixed-methods design was used. The findings of each stage informed the next stage. We conducted surveys, focus groups and in-depth interviews.
Professionals who work with young people who use standing frames and parents who have a child who uses a standing frame took part in a survey of current standing frame practice ( = 551), a series of focus groups (seven focus groups, 49 participants in total) and a survey of research trial acceptability and feasibility ( = 585). Twelve young people who use a standing frame were interviewed.
Standing frames were widely used as part of postural management for young people with CP both in school and at home but more frequently in school, and particularly by young people in primary school. Achieving the prescribed use was not always possible owing to resources, environment and family factors. Participation and activity engagement were important to young people. The majority of participants believed that standing frames research is necessary. Some reported concern that stopping standing frame use for a trial would cause irreversible damage. The maximum amount of time most health professionals and parents would agree to suspend standing frame use would be 12 weeks.
Owing to the nature of recruitment, we could not calculate response rates or determine non-response bias. Therefore, participants may not be representative of all standing frame users.
Although parents and professionals who engaged in the qualitative aspect of this research and stakeholders who took part in the design workshops appreciated the lack of clinical evidence, our surveys, qualitative information and PPI demonstrated that most people had strong beliefs regarding the clinical effectiveness of standing frames. However, with key stakeholder engagement and careful planning, a trial would be acceptable.
We recommend a carefully planned trial that includes a pilot phase. The trial should evaluate the following question: 'does using a standing frame in school improve patient-reported outcomes of participation (primary outcome), quality of life, subjective well-being, body function and body structure (secondary outcomes) in young children (aged 4-11 years) with CP GMFCS III-V?'.
The National Institute for Health Research Health Technology Assessment programme.
站立架被推荐作为脑瘫（CP）粗大运动功能分级系统（GMFCS）IV 或 V 级青少年姿势管理的一部分。它们可能具有多种益处，包括改善骨密度、胃肠道功能和社会参与度。鉴于使用成本的影响和报告的负面效应（例如疼痛），国民保健制度需要了解这些益处是否真实。站立架的临床效果缺乏证据表明需要进行评估性研究。
本研究旨在探讨未来试验的可接受性，以确定站立架的临床效果。
采用序贯混合方法设计。每个阶段的结果为下一个阶段提供信息。我们进行了调查、焦点小组和深入访谈。
参与当前站立架实践调查（ = 551）、一系列焦点小组（七个焦点小组，共 49 名参与者）和研究试验可接受性和可行性调查（ = 585）的使用站立架的年轻人和有孩子使用站立架的家长的专业人员参加了调查。12 名使用站立架的年轻人接受了采访。
站立架作为 CP 青少年姿势管理的一部分在学校和家中广泛使用，但在学校使用更为频繁，特别是在小学生中使用更为频繁。由于资源、环境和家庭因素，并非总能实现规定的使用。参与和活动参与对年轻人很重要。大多数参与者认为站立架研究是必要的。一些人报告说，担心停止站立架使用进行试验会造成不可逆转的损害。大多数健康专业人员和家长同意暂停使用站立架的最长时间将是 12 周。
由于招募的性质，我们无法计算回复率或确定非回复偏差。因此，参与者可能无法代表所有站立架使用者。
尽管参与本研究定性部分的家长和专业人员以及参与设计研讨会的利益相关者赞赏缺乏临床证据，但我们的调查、定性信息和 PPI 表明，大多数人对站立架的临床效果有强烈的信念。然而，通过主要利益相关者的参与和精心规划，试验是可以接受的。
我们建议进行一项精心计划的试验，包括试点阶段。该试验应评估以下问题：“在 CP GMFCS III-V 的 4-11 岁幼儿中，在学校使用站立架是否能改善患者报告的参与度（主要结局）、生活质量、主观幸福感、身体功能和身体结构（次要结局）？”
英国国家卫生研究院健康技术评估计划。
