Wong Yih, Ada Louise, Månum Grethe, Langhammer Birgitta
Research Department, Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Pilot Feasibility Stud. 2023 Jul 27;9(1):132. doi: 10.1186/s40814-023-01353-8.
Dynamic hand orthosis may help upper limb recovery by keeping the wrist and hand in an optimal position while executing a grasp. Our aim was to investigate the feasibility of combining a dynamic hand orthosis with task-oriented upper limb practice after stroke.
Fifteen adult stroke survivors were recruited in a single-group, pre-post intervention study. They received 12 weeks of task-oriented upper limb training with a dynamic hand orthosis with 3 weeks supervised at a community rehabilitation unit followed by 9 weeks unsupervised at home. Feasibility was determined by recruitment (proportion of eligible/enrolled and enrolled/retained participants), intervention (adherence, acceptability, and safety) and measurement (time taken to collect outcomes and proportion of participants where all measures were collected). Clinical outcomes were measured at baseline (Week 0), end of Week 3 and Week 12.
Fifteen (46%) of eligible volunteers were enrolled in the study. Eight (53%) of those enrolled completed the 12-week intervention. Eighty eight percent were satisfied or very satisfied with the dynamic hand orthosis. Clinical measures were collected for all participants at baseline and in all those who completed the intervention but often took over one hour to complete. At 12 weeks, participants had improved by 7 points out of 57 (95% CI 2 to 13) on the ARAT and by 8 points out of 66 (95% CI 0 to 15) on the FMA-UE.
The intervention appears to be feasible in terms of acceptability and safety, while recruitment and measurement need further consideration. The magnitude of the clinical outcomes suggests that the intervention has a potential to improve both upper limb activity and impairment, and this study provides useful information for the design of a pilot randomized trial.
ClinicalTrials.gov Identifier: NCT03396939.
动态手部矫形器可通过在执行抓握动作时将手腕和手部保持在最佳位置来帮助上肢恢复。我们的目的是研究在中风后将动态手部矫形器与任务导向性上肢训练相结合的可行性。
在一项单组前后干预研究中招募了15名成年中风幸存者。他们接受了为期12周的任务导向性上肢训练,并佩戴动态手部矫形器,其中3周在社区康复机构接受监督,随后9周在家中无监督训练。通过招募情况(符合条件/入选和入选/留存参与者的比例)、干预情况(依从性、可接受性和安全性)以及测量情况(收集结果所需时间和所有测量指标均被收集的参与者比例)来确定可行性。在基线(第0周)、第3周结束和第12周时测量临床结果。
15名(46%)符合条件的志愿者入选了该研究。其中8名(53%)入选者完成了12周的干预。88%的人对动态手部矫形器感到满意或非常满意。在基线时为所有参与者收集了临床测量指标,并且在所有完成干预的参与者中也进行了收集,但通常需要一个多小时才能完成。在12周时,参与者在动作研究上肢测试(ARAT)中从57分提高了7分(95%置信区间2至13),在 Fugl-Meyer 上肢功能评估量表(FMA-UE)中从66分提高了8分(95%置信区间0至15)。
就可接受性和安全性而言,该干预似乎是可行的,而招募和测量方面需要进一步考虑。临床结果的幅度表明该干预有改善上肢活动和损伤的潜力,并且本研究为设计一项初步随机试验提供了有用信息。
ClinicalTrials.gov标识符:NCT03396939。