King Erin C, Doherty Megan, Corcos Daniel, Stoykov Mary Ellen
Interdepartmental Neuroscience Program, Northwestern University, 645 N Michigan Ave, STE 1100, Chicago, IL 60611 USA.
Swedish Medical Center, Englewood, Colorado USA.
Pilot Feasibility Stud. 2020 Oct 24;6:160. doi: 10.1186/s40814-020-00696-w. eCollection 2020.
There are limited effective and evidence-based interventions for upper extremity hemiparesis post-stroke. To prepare for an RCT and minimize misuse of resources, there is value in conducting a feasibility study.
To examine the feasibility of recruitment and other related outcomes for an intense upper limb intervention.
Feasibility outcomes included retention, adherence, accrual rate, sample characteristics, and identification of productive recruitment methods. Other outcomes included satisfaction with the study, fidelity, and equipoise of both staff and participants.
Participants were enrolled at a rate of 1.33 per month. The recruitment timeline had to be extended by 4 months, to meet the target of 16 randomized participants. Staggered recruitment was the most successful strategy. We found that following up with individuals who missed initial appointments prior to study enrollment led to decreased adherence.
It is feasible to recruit and retain post-stroke participants for an intense intervention study.
NCT02277028.
对于中风后上肢偏瘫,有效的循证干预措施有限。为准备一项随机对照试验并尽量减少资源的滥用,开展可行性研究具有重要意义。
探讨针对强化上肢干预进行招募及其他相关结果的可行性。
可行性结果包括保留率、依从性、入组率、样本特征以及确定有效的招募方法。其他结果包括工作人员和参与者对研究的满意度、保真度以及均衡性。
参与者的入组率为每月1.33人。招募时间表不得不延长4个月,以达到16名随机参与者的目标。交错招募是最成功的策略。我们发现,在研究入组前对错过初次预约的个体进行跟进会导致依从性下降。
为强化干预研究招募并留住中风后参与者是可行的。
NCT02277028。