Wallin A, Franzén E, Ekman U, Piehl F, Johansson S
Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden.
Rehab Station Stockholm, Research and Development Unit, Solna, Sweden.
Pilot Feasibility Stud. 2023 Mar 15;9(1):41. doi: 10.1186/s40814-023-01265-7.
Balance training interventions with a gradual progression of difficulty and highly challenging tasks designed specifically for people with multiple sclerosis (MS) are rare. The objective was to adapt a balance training intervention originally developed for Parkinson's disease through a co-design process and then conduct a pilot trial in MS to evaluate the feasibility of a large, full-scale study.
Twelve people with MS with mild to moderate overall MS-disability were included in this single-group feasibility trial. Participants received one-hour training sessions twice or three times weekly for 10 weeks. The assessment included tests of physical and cognitive functioning and patient-reported quality of life-related outcomes. Data on feasibility aspects were collected at baseline and follow-up assessments and three times during the intervention period to inform the recruitment process, as well as to monitor retention and inclusion rates, study procedures, intervention delivery, and dynamic changes in the selected potential outcome measures. Progression criteria were used to determine whether to proceed to a full-scale trial. Descriptive statistics were used to present the data.
Out of six progression criteria, only retention and attendance at training sessions were not met. Reasons reported for not completing the intervention period mainly depended on external circumstances beyond the control of the study. In contrast, study procedures, intervention delivery, and intervention content (progression, adjustment, and control of challenge level of exercises) were considered feasible for a future, full-scale trial. The Mini-BESTest, which was used for the assessment of balance control, was considered suitable as the primary outcome in a full-scale trial with no ceiling or floor effects. Further, the Mini-BESTest showed a positive trend in outcome response with a median difference of 3.5 points between baseline and follow-up assessments. The power calculation performed suggests a feasible number of participants for recruitment.
Overall trial aspects and intervention delivery were deemed feasible for a full-scale trial, but adjustments are needed to increase retention and attendance.
针对多发性硬化症(MS)患者设计的、难度逐步递增且包含极具挑战性任务的平衡训练干预措施较为罕见。本研究的目的是通过共同设计过程,对最初为帕金森病开发的平衡训练干预措施进行调整,然后在MS患者中开展一项试点试验,以评估大规模全面研究的可行性。
本单组可行性试验纳入了12名整体MS残疾程度为轻度至中度的MS患者。参与者每周接受两次或三次一小时的训练课程,为期10周。评估包括身体和认知功能测试以及患者报告的与生活质量相关的结果。在基线和随访评估时以及干预期间收集三次关于可行性方面的数据,以指导招募过程,并监测留存率和纳入率、研究程序、干预实施情况以及所选潜在结果指标的动态变化。使用进展标准来确定是否进行全面试验。采用描述性统计方法呈现数据。
在六个进展标准中,只有训练课程的留存率和出勤率未达到。报告的未完成干预期的原因主要取决于研究无法控制的外部情况。相比之下,研究程序、干预实施情况和干预内容(练习挑战水平的进展、调整和控制)被认为对未来的全面试验是可行的。用于评估平衡控制的Mini-BESTest被认为适合作为全面试验的主要结果指标,不存在天花板效应或地板效应。此外,Mini-BESTest在结果反应方面呈现出积极趋势,基线和随访评估之间的中位数差异为3.5分。进行的功效计算表明招募的参与者数量可行。
总体试验方面和干预实施情况被认为对全面试验是可行的,但需要进行调整以提高留存率和出勤率。