Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial.

Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial.
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DOI:
10.3389/fnins.2018.00752
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发表时间:
2018
影响因子:
4.3
通讯作者:
Prabhakaran V
Prabhakaran V
中科院分区:
医学2区
文献类型:
--
作者:
Remsik AB;Dodd K;Williams L Jr;Thoma J;Jacobson T;Allen JD;Advani H;Mohanty R;McMillan M;Rajan S;Walczak M;Young BM;Nigogosyan Z;Rivera CA;Mazrooyisebdani M;Tellapragada N;Walton LM;Gjini K;van Kan PLE;Kang TJ;Sattin JA;Nair VA;Edwards DF;Williams JC;Prabhakaran V

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中风是成人持续性上肢(UE)运动障碍的主要原因。脑机接口(BCI)干预已被证明具有作为中风幸存者运动康复策略的潜力。这项正在进行的临床试验 (NCT02098265) 的子分析检查了这种 BCI 设计的康复功效,并试图确定与行为改善相关的中风参与者特征。使用行动研究手臂测试 (ARAT) 和功能测量对患有 UE 损伤的中风参与者 (n = 21) 进行评估。九名参与者在实验性 BCI 干预期间和 1 个月的随访期间完成了三项评估。其他 12 名参与者首先在平行的时间匹配控制期内完成了三项评估,然后在 1 个月后进入 BCI 干预条件。在干预期的第一次和第三次评估之间,中风影响的 UE 的 ARAT 总表现出现积极变化(≥1 分)的参与者被分为“有反应者”(<1 =“无反应者”)并进行类似分析。在 14 名有 ARAT 改进空间的参与者中,64% (9/14) 在完成时表现出一些积极的变化,大约 43% (6/14) 的参与者出现了最小可检测变化 (MDC = 3 分) 或最小临床重要差异 (MCID = 5.7 分)。在控制严重性、性别、长期性和一致性的情况下,主要结局指标有改善空间的参与者在完成时的 ARAT 总分 (ΔARATtotal = 2,p = 0.028) 和 1 个月随访时 (ΔARATtotal = 3.4,p = 0.0010) 平均得分显着提高。次要结果指标 SISmobility、SISadl、SISstrength 和 9HPTaffected 在干预期间也显示出随着时间的推移显着改善。通过随访进行干预的参与者显示,与对照组相比,SIS强度的改善率显着增加(p = 0.0117),控制了严重性、长期性、性别以及时间和干预类型的个体影响。根据 ARAT 评分改善情况评估,对 BCI 干预反应最佳的参与者通过完成和随访 SISmobility(p = 0.0002,p = 0.002)和 SISstrength(p = 0.04995,p = 0.0483)显示结果值显着增加。这些发现可能表明可能的次要结果测量模式表明这种 BCI 干预方案带来的改善有所增加,并证明了这种 BCI 设计对于治疗中风幸存者 UE 损伤的主要功效。临床试验注册:ClinicalTrials.gov,NCT02098265。
Stroke is a leading cause of persistent upper extremity (UE) motor disability in adults. Brain–computer interface (BCI) intervention has demonstrated potential as a motor rehabilitation strategy for stroke survivors. This sub-analysis of ongoing clinical trial (NCT02098265) examines rehabilitative efficacy of this BCI design and seeks to identify stroke participant characteristics associated with behavioral improvement. Stroke participants (n = 21) with UE impairment were assessed using Action Research Arm Test (ARAT) and measures of function. Nine participants completed three assessments during the experimental BCI intervention period and at 1-month follow-up. Twelve other participants first completed three assessments over a parallel time-matched control period and then crossed over into the BCI intervention condition 1-month later. Participants who realized positive change (≥1 point) in total ARAT performance of the stroke affected UE between the first and third assessments of the intervention period were dichotomized as “responders” (<1 = “non-responders”) and similarly analyzed. Of the 14 participants with room for ARAT improvement, 64% (9/14) showed some positive change at completion and approximately 43% (6/14) of the participants had changes of minimal detectable change (MDC = 3 pts) or minimally clinical important difference (MCID = 5.7 points). Participants with room for improvement in the primary outcome measure made significant mean gains in ARATtotal score at completion (ΔARATtotal = 2, p = 0.028) and 1-month follow-up (ΔARATtotal = 3.4, p = 0.0010), controlling for severity, gender, chronicity, and concordance. Secondary outcome measures, SISmobility, SISadl, SISstrength, and 9HPTaffected, also showed significant improvement over time during intervention. Participants in intervention through follow-up showed a significantly increased improvement rate in SISstrength compared to controls (p = 0.0117), controlling for severity, chronicity, gender, as well as the individual effects of time and intervention type. Participants who best responded to BCI intervention, as evaluated by ARAT score improvement, showed significantly increased outcome values through completion and follow-up for SISmobility (p = 0.0002, p = 0.002) and SISstrength (p = 0.04995, p = 0.0483). These findings may suggest possible secondary outcome measure patterns indicative of increased improvement resulting from this BCI intervention regimen as well as demonstrating primary efficacy of this BCI design for treatment of UE impairment in stroke survivors. Clinical Trial Registration: ClinicalTrials.gov, NCT02098265.
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