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Feasibility study of randomized supplemental therapeutic lower limb exercise in acute stroke rehabilitation

机译:随机补充性下肢运动疗法在急性中风康复中的可行性研究

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Objectives: To determine the feasibility and tolerability of supplemental therapeutic lower limb walking exercise in acute stroke rehabilitation with either a robotic or conventional therapy intervention. If the pilot study is feasible and tolerable, we will collect secondary outcome measures to determine power and sample size for a larger clinical trial. Methods: Participants - Acute stroke patients with unilateral hemiparesis ≥ 18 years of age with a MAS ≤3. Intervention - Patients participated in conventional therapy that will assure compliance with mandates of time and staff (3 hours of one-to-one therapy). Participants received supplemental therapy of either 30 minutes of conventional (control) or 30 minutes of Lokomat® training (intervention) aimed at walking up to 5 days per week. Their overall involvement in the study is dependent on their length of stay. Main Outcome Measures - tolerability; Length of Stay (LOS); Functional Independence Measure (FIM); Functional Ambulation Category (FAC); Passive Range of Motion (PROM); Modified Ashworth Scale (MAS); 10 Meter walk test (10MWT); 2-Minute walk test (2MWT); 5 Times sit-to-stand (5x-STS) and Modified Borg Rating of Perceived Exertion Scale (RPE) for therapist. Results: 10 patients currently enrolled (2: Lokomat; 8: Conventional). Most of the participants were male (n=7) and the average age was 56. Seventy percent of the patients had ischemic strokes with left sided paresis (80%). The following adverse events were reported: skin irritation; technical problems with the Lokomat and scheduling conflicts. Based on the interim data analysis, the average FIM gain total was 25.4 points for the conventional group and 27.0 points for the Lokomat group. The average FIM efficiency was 1.2 for the conventional group and 1.3 for the Lokomat group. Conclusions: These preliminary findings provide a proof-of-concept demonstration that an additional lower limb exercise in combination with mandated multi-disciplinary therapies in acute stroke population is feasible.
机译:目的:确定通过机器人或常规疗法干预在急性中风康复中补充治疗性下肢步行运动的可行性和耐受性。如果该初步研究可行且可忍受,我们将收集次要结局指标,以确定更大的临床试验的功效和样本量。方法:参与者-单侧偏瘫≥18岁且MAS≤3的急性中风患者。干预-患者参加了常规治疗,以确保符合时间和人员的要求(一对​​一治疗3小时)。参与者接受了30分钟的常规(对照)或30分钟的Lokomat®培训(干预)的补充治疗,旨在每周步行5天。他们对研究的整体参与取决于他们的停留时间。主要结果指标-耐受性;停留时间(LOS);功能独立性度量(FIM);功能性移动类别(FAC);被动运动范围(PROM);改良的Ashworth量表(MAS); 10米步行测试(10MWT); 2分钟步行测试(2MWT);坐着站立5倍(5x-STS)和改良的博格感知运动量表(RPE)对治疗师的评价。结果:目前招募了10名患者(2名:Lokomat; 8名:常规)。大多数参与者为男性(n = 7),平均年龄为56岁。70%的患者患有缺血性中风并伴有左侧轻瘫(80%)。报告了以下不良事件:皮肤刺激; Lokomat的技术问题和计划冲突。根据中期数据分析,常规组的平均FIM增益总计为25.4点,Lokomat组的平均FIM增益总计为27.0点。传统组的平均FIM效率为1.2,Lokomat组的平均FIM效率为1.3。结论:这些初步发现提供了概念证明,证明在急性卒中人群中进行额外的下肢运动结合强制性多学科治疗是可行的。

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