1 Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
2 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Clin Rehabil. 2019 Aug;33(8):1391-1403. doi: 10.1177/0269215519834720. Epub 2019 Mar 7.
To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke.
Parallel-group pilot RCT.
Four English stroke services.
Patients 0-3 months post stroke with a new arm deficit.
Participants were randomized to wear a prompting or 'sham' wristband during a four-week self-directed therapy programme with twice-weekly therapy review.
Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison.
In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5-45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group ( = 19) were 15 (2-35), 35 (15-26) and 31 (21-55) and those for the intervention group (n = 14) were 37 (16-45), 57 (29-57) and 57 (37-57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0-1.2), 1.1 (0.3-2.9) and 1.2 (0.7-2.9) and in the intervention group were 1.4 (0.5-2.6), 3.8 (1.9-4.5) and 3.7 (2.1-4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3-8.0) and 7.5 (IQR: 6.8-8.0) therapy reviews. A median of 8 (IQR: 6-10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention.
A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.
评估一种带有活动依赖性振动警报的腕带加速度计，以提示中风后手臂功能障碍的多中心、观察者盲法、初步随机对照试验（RCT）的可行性。
平行组初步 RCT。
四个英国中风服务机构。
中风后 0-3 个月且新出现手臂缺损的患者。
参与者被随机分配在四周的自我指导治疗计划中佩戴提示或“假”腕带，并进行每周两次的治疗评估。
报告了招募、保留和依从率、安全性以及评估完成情况。采用动作研究手臂测试（ARAT）和运动活动日志（MAL）测量手臂恢复情况，但未进行统计比较。
共招募了 33 名患者（每个月/地点 0.6 名；中位发病后时间：26 天（四分位距（IQR）：15.5-45））。对照组（n=19）的基线、四周和八周的 ARAT 中位数（IQR）分别为 15（2-35）、35（15-26）和 31（21-55），干预组（n=14）分别为 37（16-45）、57（29-57）和 57（37-57）；对于 MAL 使用量，对照组相应的值为 0.2（0.0-1.2）、1.1（0.3-2.9）和 1.2（0.7-2.9），干预组分别为 1.4（0.5-2.6）、3.8（1.9-4.5）和 3.7（2.1-4.3）。有 4 名参与者退出了研究。腕带的佩戴时间占推荐时间的 79%。干预组和对照组参与者分别接受了中位数为 6.0（IQR：4.3-8.0）和 7.5（IQR：6.8-8.0）的治疗评估。干预组每个参与者每天收到的提示中位数为 8（IQR：6-10）个。28/29 和 25/28 名患者在四周和八周时完成了研究评估。报告了 8 例严重不良事件，均与干预无关。
多中心 RCT 评估了中风后早期使用腕带加速度计来提示手臂活动的可行性。需要 108 名参与者的总样本量。
