Cummings Mark, Pradhan Sonia, Madhavan Sangeetha
Brain Plasticity Laboratory, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois, Chicago, IL, USA.
Graduate Program in Rehabilitation Science, College of Applied Health Sciences, University of Illinois, Chicago, IL, USA.
Contemp Clin Trials Commun. 2022 Jun 11;28:100945. doi: 10.1016/j.conctc.2022.100945. eCollection 2022 Aug.
Individuals with stroke face a distinct set of challenges, barriers and facilitators that need to be understood to streamline efficacy of stroke clinical trials and improve participant retention. Few long-term stroke rehabilitation trials have evaluated participant perception of their laboratory experience.
We collected data regarding trial satisfaction from 33 individuals with stroke who participated in 12 sessions of treadmill training which included pre, post and follow-up non-invasive brain stimulation and clinical assessments. We evaluated factors such as overall trial satisfaction, burden of testing, perceived benefits, perceived barriers, and perceived support using a participant satisfaction questionnaire (PSQ) that assessed participants' overall trial experience.
97% of our participants found participating in the study to be rewarding and would recommend it to other persons with stroke. Transcranial magnetic stimulation (TMS) testing was found to be the major perceived burden of participation while travelling to the lab was found to be the major perceived barrier to participation. Significant correlations were found between various items of the PSQ and clinical assessments.
This study helped us get a preliminary perspective into the benefits and barriers faced by persons with stroke enrolled in a 4-week long clinical trial. We observed that participant satisfaction was driven by various factors including functional status, personal relevance to the research, perceptive physical and mental health improvements, interaction with research personnel, and ease of testing protocols.
中风患者面临一系列独特的挑战、障碍和促进因素,为提高中风临床试验的有效性并改善受试者留存率,有必要对这些因素加以了解。很少有长期中风康复试验评估受试者对其实验室体验的看法。
我们收集了33名参与12次跑步机训练课程的中风患者的试验满意度数据,这些课程包括术前、术后及随访时的无创脑刺激和临床评估。我们使用一份评估受试者总体试验体验的受试者满意度问卷(PSQ),对总体试验满意度、测试负担、感知到的益处、感知到的障碍和感知到的支持等因素进行了评估。
97%的受试者认为参与该研究很有意义,并会向其他中风患者推荐。经颅磁刺激(TMS)测试被认为是参与研究的主要负担,而前往实验室的行程被认为是参与研究的主要障碍。PSQ的各项内容与临床评估之间存在显著相关性。
本研究有助于我们初步了解参与一项为期4周的临床试验的中风患者所面临的益处和障碍。我们观察到,受试者的满意度受多种因素驱动,包括功能状态、与研究的个人相关性、感知到的身心健康改善、与研究人员的互动以及测试方案的简便程度。