Turton A J, Cunningham P, van Wijck F, Smartt Hjm, Rogers C A, Sackley C M, Jowett S, Wolf S L, Wheatley K, van Vliet P
1 Department of Allied Health Professions, University of the West of England, UK.
2 Institute for Applied Health Research and School of Health and Life Sciences, Glasgow Caledonian University, UK.
Clin Rehabil. 2017 Jul;31(7):891-903. doi: 10.1177/0269215516661751. Epub 2016 Jul 28.
To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke.
single-blind parallel group RCT.
Residual arm deficit less than 12 months post-stroke.
Reach-to-Grasp training in 14 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours).
Usual care.
Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation.
Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment.
An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.
确定中风后基于家庭的抓握训练随机对照试验(RCT)的可行性。
单盲平行组随机对照试验。
中风后12个月内存在残留手臂功能障碍。
在6周内由治疗师进行14次每次1小时的抓握训练,并加上每天1小时的自我练习(共56小时)。
常规护理。
行动研究手臂测试(ARAT)、沃尔夫运动功能测试(WMFT),随机分组前、随机分组后7周、12周、24周进行测量。
在17个月内对47名参与者进行了随机分组(抓握训练组 = 24人,常规护理组 = 23人)。抓握训练组参与者接受的治疗师访视次数中位数(四分位间距)为14次(13,14),每次访视进行157次(96,211)重复练习;每天自我练习30分钟(22,45)。常规护理组参与者接受10.5次(5,14)治疗师访视,每次访视包括38.6分钟(30,45)的手臂治疗,进行16次(6,24)功能性任务重复练习。抓握训练组在基线时ARAT评分中位数为8.5(3.0,24.0),24周时为14.5(3.5,26.0);而常规护理组在两个时间点的中位数均为4(四分位间距:基线时(3.0,14.0),24周时(3.0,30.0))。抓握训练组在基线和24周时完成的WMFT任务中位数分别为6(3.0,11.5)和8.5(4.5,13.5),常规护理组分别为4(3.0,10.0)、6(3.0,14.0)。两组手臂疼痛发生率相似。在11名患者达到24周评估之前,该研究停止。
中风后基于家庭的抓握训练随机对照试验是可行且安全的。以ARAT作为我们首选的测量指标,估计未来双臂试验需要240名参与者。