棱镜与疗法治疗脑卒中后注意力缺失的研究（SPATIAL）：一项可行性随机对照试验。
A study of prisms and therapy in attention loss after stroke (SPATIAL): A feasibility randomised controlled trial.
机构信息
Faculty of Health and Education, 5289Manchester Metropolitan University, Manchester, UK.
Geoffrey Jefferson Brain Research Centre, The Manchester Academic Health Science Centre, Northern Care Alliance & University of Manchester, Manchester, UK.
出版信息
Clin Rehabil. 2023 Mar;37(3):381-393. doi: 10.1177/02692155221134060. Epub 2022 Oct 26.
OBJECTIVE
Investigate feasibility and acceptability of prism adaptation training for people with inattention (spatial neglect), early after stroke, during usual care.
DESIGN
Phase II feasibility randomised controlled trial with 3:1 stratified allocation to standard occupational therapy with or without intervention, and nested process evaluation.
SETTING
Ten hospital sites providing in-patient stroke services.
PARTICIPANTS
Screened positive for inattention more than one-week post-stroke; informal carers. Occupational therapists participated in qualitative interviews.
INTERVENTION
Adjunctive prism adaptation training at the start of standard occupational therapy sessions for three weeks.
MAIN MEASURES
Feasibility measures included recruitment and retention rates, intervention fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks tested measures including Nottingham Extended Activities of Daily Living Scale. Acceptability was explored through qualitative interviews and structured questions.
RESULTS
Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised (40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment fidelity was good: participants received median eight intervention sessions (IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events were unrelated. There was no signal that patients allocated to intervention did better than controls. Twenty five of 35 recruited carers provided outcomes with excellent data completeness. Therapists, patients and carers found prism adaptation training acceptable.
CONCLUSIONS
It is feasible and acceptable to conduct a high-quality definitive trial of prism adaptation training within occupational therapy early after stroke in usual care setting, but difficult to justify given no sign of benefit over standard occupational therapy.
CLINICAL TRIAL REGISTRATION
https://www.isrctn.com/ Ref ISRCTN88395268.
目的
在常规治疗中，调查早期脑卒中后注意力不集中（空间忽略）患者进行棱镜适应训练的可行性和可接受性。
设计
二期可行性随机对照试验，采用 3:1 分层分配，标准作业治疗加或不加干预，并进行嵌套过程评估。
设置
提供住院脑卒中服务的 10 个医院地点。
参与者
脑卒中后超过一周筛查出注意力不集中阳性；非正式照顾者。作业治疗师参与了定性访谈。
干预
在标准作业治疗开始时辅助棱镜适应训练，为期三周。
主要措施
可行性措施包括招募和保留率、干预一致性和流失率。在基线、3 周和 12 周收集的结果测试了包括诺丁汉扩展日常生活活动量表在内的措施。通过定性访谈和结构化问题探讨了可接受性。
结果
80 名（31%）患者符合条件，57 名（71%）同意，54 名随机分组（40:13，+1 排除），39 名（74%）完成 12 周的结果。治疗一致性良好：参与者接受中位数 8 次干预（IQR：5、12），每次持续 4.7 分钟（IQR：4.1、5.0）。所有 6 例严重不良事件均与治疗无关。没有信号表明分配给干预的患者比对照组表现更好。招募的 35 名照顾者中有 25 名提供了结果，数据完整性极佳。治疗师、患者和照顾者认为棱镜适应训练是可以接受的。
结论
在常规治疗中，在脑卒中后早期进行作业治疗中加入棱镜适应训练进行高质量的确定性试验是可行和可接受的，但鉴于没有比标准作业治疗更好的效果，很难证明其合理性。
临床试验注册
https://www.isrctn.com/ Ref ISRCTN88395268。
Zotero 插件