Carlsson Håkan, Rosén Birgitta, Pessah-Rasmussen Hélène, Björkman Anders, Brogårdh Christina
Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden.
Department of Health Sciences, Lund University, Lund, Sweden.
Trials. 2018 Apr 17;19(1):229. doi: 10.1186/s13063-018-2628-1.
Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation, and life satisfaction.
METHODS/DESIGN: This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5 h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment-upper extremity (FMA-UE; sensory section), and tactile object identification test. The secondary outcome measures to assess motor function are as follows: Box and Block Test (BBT), mini Sollerman Hand Function Test (mSHFT), Modified Motor Assessment Scale (M-MAS), and Grippit. To assess the ability to use the hand in daily activities, perceived participation, and life satisfaction, the Motor Activity Log (MAL), Canadian Occupational Performance Measure (COPM), Stroke Impact Scale (SIS) participation domain, and Life Satisfaction checklist will be used. Assessments will be performed pre- and post-training and at 3-month follow-up by independent assessors, who are blinded to the participants' group allocation. At the 3-month follow-up, the participants in the sensory group will also be interviewed about their general experience of the training and how effective they perceived the training.
The results from this study can add new knowledge about the effectiveness of sensory re-learning in combination with task-specific training on UL functioning after stroke. If the new training approach proves efficient, the results can provide information on how to design a larger RCT in the future in persons with sensory impairments of the UL after stroke.
ClinicalTrials.gov, NCT03336749 . Registered on 8 November 2017.
许多中风幸存者患侧上肢存在感觉障碍。尽管这些障碍会影响上肢在日常活动中的使用能力，但中风康复中对感觉障碍的关注却很少。本试验的目的是研究感觉再学习结合特定任务训练是否比单纯的特定任务训练在改善手部感觉功能、灵活性、手部在日常活动中的使用能力、感知到的参与度和生活满意度方面更有效。
方法/设计：本研究是一项单盲试点随机对照试验（RCT），有两个治疗组。参与者将被随机分配到感觉再学习结合特定任务训练组（感觉组）或仅特定任务训练组（对照组）。训练包括每次2.5小时的小组训练，每周2次，共5周。评估感觉功能的主要结局指标如下：Semmes-Weinstein单丝、形状/质地识别（STI™）测试、Fugl-Meyer上肢评估（FMA-UE；感觉部分）和触觉物体识别测试。评估运动功能的次要结局指标如下：方块和积木测试（BBT）、小型Sollerman手功能测试（mSHFT）、改良运动评估量表（M-MAS）和握力测试。为了评估手部在日常活动中的使用能力、感知到的参与度和生活满意度，将使用运动活动日志（MAL）、加拿大职业表现测量（COPM）、中风影响量表（SIS）参与领域和生活满意度清单。评估将在训练前、训练后以及3个月随访时由独立评估者进行，评估者对参与者的分组情况不知情。在3个月随访时，还将对感觉组的参与者进行访谈，了解他们对训练的总体体验以及他们认为训练的效果如何。
本研究结果可为中风后上肢功能感觉再学习结合特定任务训练的有效性增添新知识。如果新的训练方法被证明有效，结果可为未来如何针对中风后上肢感觉障碍患者设计更大规模的随机对照试验提供信息。
ClinicalTrials.gov，NCT03336749。于2017年11月8日注册。
