Biofeedback

生物反馈
  • 文章类型: Journal Article
    目的:本研究旨在探讨生物反馈(BF)对非神经功能障碍(NDV)患儿康复的影响。
    方法:RCT从各种数据库中检索(从开始到2024年2月29日发布)。比较了BF和非BF处理的效果。使用随机效应模型来评估组合数据。
    结果:荟萃分析显示BF增加了最大尿流率(SMD=3.78,95%CI1.33~6.22),改善排尿时间(SMD=5.88,95%CI3.75~8.01),并降低了尿路感染后残留(SMD=-19.18,95%CI-27.03~-11.33)和尿路感染发生率(RR=0.43,95%CI0.21~0.87)。肌电图活动(RR=0.46,95%CI0.25~0.84)和排尿异常模式(RR=0.51,95%CI0.35~0.74)改善,效果持续超过1年。然而,仅随访1年后,BF对NDV患儿平均尿流率的影响才有统计学意义(SMD=1.90,95%CI0.87~2.92)。
    结论:现有证据表明,BF可以增强NDV患儿的尿路参数和模式。然而,它在解决便秘方面的有效性,白天尿失禁,夜间尿失禁并不严重。高质量的随机对照试验可以提供更多的见解。
    OBJECTIVE: This study was conducted to investigate the effect of biofeedback (BF) on the rehabilitation of children with nonneurological dysfunctional voiding (NDV).
    METHODS: RCTs were retrieved from various databases (published from inception to February 29, 2024). The effects of the BF and non-BF treatments were compared. A random-effects model was used to evaluate the combined data.
    RESULTS: Meta-analysis revealed that BF increased the maximum urinary flow rate (SMD = 3.78, 95% CI 1.33∼6.22), improved urination time (SMD = 5.88, 95% CI 3.75∼8.01), and reduced the postvoid residual (SMD = -19.18, 95% CI -27.03∼-11.33) and urinary tract infection incidence (RR = 0.43, 95% CI 0.21∼0.87). Electromyogram activity (RR = 0.46, 95% CI 0.25∼0.84) and abnormal urination patterns (RR = 0.51, 95% CI 0.35∼0.74) improved, with effects persisting for more than 1 year. However, the effect of BF on the mean urinary flow rate in children with NDV was significant only after 1 year of follow-up (SMD = 1.90, 95% CI 0.87∼2.92).
    CONCLUSIONS: Existing evidence indicates that BF can enhance urinary parameters and patterns in children with NDV. However, its effectiveness in addressing constipation, daytime urinary incontinence, and nocturnal urinary incontinence is not substantial. High-quality randomized controlled trials can offer additional insights.
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  • 文章类型: Journal Article
    盆底疾病(PFD),如压力性尿失禁(SUI)和盆腔器官脱垂(POP),可以通过保守治疗,例如涉及生物反馈(BF)和电刺激的保守管理。本研究旨在探讨保守治疗对PFDs的治疗效果。
    进行了一项回顾性队列研究。在2020年1月1日至2021年1月31日期间接受1-3个月BF和电刺激的PFD女性被纳入研究。BF治疗使用三个传感器监测盆底肌肉活动,为患者提供肌肉锻炼的即时反馈和指导。一次会议持续了5-10分钟。电刺激治疗利用带有电极片的特制骨盆带被动地刺激和收缩骨盆底肌肉。一次会议持续了15分钟。在1个月内进行6次治疗。治疗前和治疗后盆底窘迫清单(PFDI-20)得分,包括POP困境清单6(POPDI-6),结直肠肛门窘迫清单(CRAD-8),和排尿窘迫清单6(UDI-6)得分,进行了比较。按年龄分组分析,更年期,体重指数(BMI),并执行儿童分娩模式。
    该研究包括51名患有PFD的女性(SUI,POP,频率或紧迫性或夜尿症,和疼痛)用BF和电刺激治疗,平均年龄49.94±13.63岁。16例(37.1%)患者绝经,平均绝经年龄为50±5.20岁。26例患者(68.4%)有正常阴道分娩史。治疗前后PFDI-20平均评分分别为32.67(标准差[SD]10.05)和25.99(SD9.61),分别(P<0.001)。分数的下降反映了对症状和生活质量的主观感知的改善。治疗后POPDI-6、CRAD-8和UDI-6评分明显下降。关于年龄的分数变化的亚组分析,更年期,BMI,分娩方式无统计学意义。
    该研究证明了BF和电刺激治疗PFD女性的有效性。这些发现有助于理解治疗持续时间,患者特征,以及多模式方法的潜在好处。此外,研究的不同参与者人群和验证的结局指标的使用增强了研究结果的普遍性和科学严谨性.
    UNASSIGNED: Pelvic floor disorders (PFDs) such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP) can be managed through conservative treatments, such as conservative management involving biofeedback (BF) and electrostimulation. This study aimed to investigate the therapeutic effects of conservative treatments on PFDs.
    UNASSIGNED: A retrospective cohort study was conducted. Women with PFD who underwent 1-3 months of BF and electrostimulation between January 1, 2020, and January 31, 2021, were included in the study. BF treatment was administered using three sensors to monitor pelvic floor muscle activity, providing patients with immediate feedback and guidance on muscle exercises. One session lasted for 5-10 min. Electrostimulation treatment utilized a specially made pelvic belt with electrode sheets to stimulate and contract pelvic floor muscles passively. One session lasted for 15 min. Six therapies in 1 month were prescribed. Pre- and post-treatment Pelvic Floor Distress Inventory (PFDI-20) scores, including POP distress inventory 6 (POPDI-6), colorectal-anal distress inventory (CRAD-8), and urinary distress inventory 6 (UDI-6) scores, were compared. Subgroup analysis by age, menopause, body mass index (BMI), and child delivery mode was performed.
    UNASSIGNED: The study included 51 women with PFDs (SUI, POP, frequency or urgency or nocturia, and pain) treated with BF and electrostimulation, with a mean age of 49.94 ± 13.63 years. Sixteen patients (37.1%) were menopausal, with a mean menopause age of 50 ± 5.20 years. Twenty-six patients (68.4%) had a history of normal vaginal delivery. The mean PFDI-20 scores before and after treatment were 32.67 (standard deviation [SD] 10.05) and 25.99 (SD 9.61), respectively (P < 0.001). This decrease in scores reflected an improvement in subjective perceptions of symptoms and quality of life. The POPDI-6, CRAD-8, and UDI-6 scores significantly decreased after treatment. Subgroup analysis of scores change regarding age, menopause, BMI, and child delivery mode was not statistically significant.
    UNASSIGNED: The study demonstrated the effectiveness of BF and electrostimulation for treating women with PFDs. The findings contributed to the understanding of treatment duration, patient characteristics, and the potential benefits of a multimodal approach. Moreover, the study\'s diverse participant population and the use of validated outcome measures enhance the generalizability and scientific rigor of the findings.
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  • 文章类型: Journal Article
    跑步者的数量和与跑步相关的伤害(RRI)的发生率都在上升。实时生物反馈步态再训练为RRI预防提供了一种有前途的方法。然而,由于研究设计和报告结果的多样性,不同形式的反馈对跑步步态生物力学的影响仍存在不确定性.三个数据库:MEDLINE,pubmed,和SPORTDiscus进行了搜索,以确定截至2024年3月发表的相关研究,产生了4646篇文章供审查。使用Downs和Black质量检查表评估纳入研究的质量。主要结果,包括胫骨峰值加速度(PTA),垂直平均加载速率(VALR),和垂直瞬时加载速率(VILR),通过荟萃分析进行分析。24项研究符合纳入标准,并在本次审查中进行了分析。17项使用视觉生物反馈(VB),而14项选择听觉生物反馈(AB)。荟萃分析显示,在干预后和长期训练后,加载变量均减少。视觉和听觉反馈。值得注意的是,训练后负荷变量的减少更为明显,VB被证明比AB更有效。实时生物反馈干预在降低与RRI相关的负载变量方面是有效的。持续训练的影响更大,VB在有效性方面优于AB。
    The number of runners and the incidence of running-related injuries (RRIs) are on the rise. Real-time biofeedback gait retraining offers a promising approach to RRIs prevention. However, due to the diversity in study designs and reported outcomes, there remains uncertainty regarding the efficacy of different forms of feedback on running gait biomechanics. Three databases: MEDLINE, PUBMED, and SPORTDiscus were searched to identify relevant studies published up to March 2024, yielding 4646 articles for review. The quality of the included studies was assessed using the Downs and Black Quality checklist. Primary outcomes, including Peak Tibial Acceleration (PTA), Vertical Average Loading Rate (VALR), and Vertical Instantaneous Loading Rate (VILR), were analysed through meta-analysis. 24 studies met the inclusion criteria and were analysed in this review.17 used visual biofeedback (VB) while 14 chose auditory biofeedback (AB). The meta-analysis revealed a reduction in loading variables both immediately following the intervention and after extended training, with both visual and auditory feedback. Notably, the decrease in loading variables was more pronounced post-training and VB proved to be more effective than AB. Real-time biofeedback interventions are effective in lowering loading variables associated with RRIs. The impact is more substantial with sustained training, and VB outperforms AB in terms of effectiveness.
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  • 文章类型: Journal Article
    目的:孤立性直肠溃疡综合征(SRUS)是一种良性且鲜为人知且治疗复杂的疾病。典型的症状包括排便时紧张,直肠出血,重弹,粘液分泌,肛门疼痛和不完全疏散感。诊断基于特征性临床症状和内窥镜/组织学发现。文献中已经报道了几种具有可变溃疡愈合率的治疗方法。本研究旨在评估不同治疗方法对SRUS的疗效。
    方法:根据PRISMA指南进行系统评价和网络荟萃分析。英语学习,包括法语和西班牙语。用其他语言写的论文被排除在外。其他排除标准是审查,病例报告或临床系列纳入少于五名患者,研究重复,没有感兴趣的临床数据,也没有文章。2000年1月至2024年3月,使用以下数据库进行了系统的文献检索:PubMed/MEDLINE,Cochrane中央控制试验登记册,Cochrane系统评价数据库,还有Scopus.在适当的情况下,使用纽卡斯尔-渥太华量表或Jadad量表评估研究的偏见。收集并严格评估治疗类型及其对SRUS治疗的疗效。该研究的主要结果是评估患者的溃疡愈合率。
    结果:在最终的荟萃分析中,共分析了22项研究,其中911例(男性361例,女性550例)被诊断为SRUS。综合疗效估计显示,手术显示溃疡愈合率最高(70.5%;95%CI0.57-0.83)。手术治疗溃疡优于药物治疗和生物反馈(OR0.09和OR0.14)。
    结论:孤立性直肠溃疡综合征是一个具有挑战性的临床治疗实体。据报道,手术方法取得了良好的结果,提示其在医疗和生物反馈治疗难治性病例中的积极作用。需要在同质人群中进行进一步的研究来评估手术在这种情况下的疗效。(PROSPERO注册号CRD42022331422)。
    OBJECTIVE: Solitary rectal ulcer syndrome (SRUS) is a benign and poorly understood disorder with complex management. Typical symptoms include straining during defaecation, rectal bleeding, tenesmus, mucoid secretion, anal pain and a sense of incomplete evacuation. Diagnosis is based on characteristic clinical symptoms and endoscopic/histological findings. Several treatments have been reported in the literature with variable ulcer healing rates. This study aimed to evaluate the efficacy of different treatments for SRUS.
    METHODS: A systematic review and network meta-analysis were performed according to the PRISMA guidelines. Studies in English, French and Spanish languages were included. Papers written in other languages were excluded. Other exclusion criteria were reviews, case reports or clinical series enrolling less than five patients, study duplications, no clinical data of interest and no article available. A systematic literature search was conducted from January 2000 to March 2024 using the following databases: PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Scopus. The biases of the studies were assessed using the Newcastle-Ottawa scale or the Jadad scale when appropriate. Types of treatment and their efficacy for the cure of SRUS were collected and critically assessed. The study\'s primary outcome was to estimate the rate of patients with ulcer healing.
    RESULTS: A total of 22 studies with 911 patients (men 361, women 550) diagnosed with SRUS were analysed in the final meta-analysis. The pooled effect estimates of treatment efficacy revealed that surgery showed the highest ulcer healing rate (70.5%; 95% CI 0.57-0.83). Surgery was superior in the cure of ulcers with respect to medical therapies and biofeedback (OR 0.09 and OR 0.14).
    CONCLUSIONS: Solitary rectal ulcer syndrome is a challenging clinical entity to manage. Proficient results have been reported with the surgical approach, suggesting its positive role in cases refractory to medical and biofeedback therapy. Further studies in homogeneous populations are required to evaluate the efficacy of surgery in this setting. (PROSPERO registration number CRD42022331422).
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  • 文章类型: Journal Article
    背景:低位前切除综合征(LARS)是一种令人痛苦的疾病,影响约25-80%的直肠癌手术后患者。LARS的特点是使人衰弱的肠功能障碍症状,包括大便失禁,紧急排便,排便频率增加.尽管生物反馈疗法已证明在改善术后直肠控制方面有效,研究结果没有达到预期。最近的研究强调,刺激阴部会阴神经比单独的生物反馈对增强盆底肌肉功能具有更好的影响。因此,本研究旨在通过一项随机对照试验(RCT),评估生物反馈与经皮阴部神经电刺激(B-PEPNS)联合治疗LARS患者的疗效.
    方法:在这个双臂多中心RCT中,242名直肠手术后LARS的参与者将被随机分配接受B-PEPNS(干预组)或生物反馈(对照组)。超过4周,每位参与者将接受20次治疗.主要结果将是LARS得分。次要结果将是肛门直肠测压和盆底肌肌电图检查结果以及欧洲癌症研究和治疗组织生活质量问卷-结肠直肠29(EORTCQLQ-CR29)评分。数据将在基线时收集,干预后(1个月),并随访(6个月)。
    结论:我们预计这项研究将进一步证明B-PEPNS在减轻直肠癌术后患者LARS症状和提高生活质量方面的有效性。
    背景:中国临床试验注册ChiCTR2300078101。2023年11月28日注册。
    BACKGROUND: Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT).
    METHODS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).
    CONCLUSIONS: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.
    BACKGROUND: Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.
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  • 文章类型: Journal Article
    心率变异性生物反馈(HRVB)是一种经过充分研究的干预措施,以其对情绪的积极影响而闻名。认知,和生理健康,包括缓解抑郁症状.然而,它的实际使用受到高成本和缺乏训练有素的专业人员的阻碍。基于智能手机的HRVB,这消除了对外部设备的需求,提供了一个有希望的替代方案,尽管研究有限。此外,经前症状在经期个体中非常普遍,需要低成本,可获得的干预措施,副作用最小。通过这项试点研究,我们的目标是测试,第一次,基于智能手机的HRVB对抑郁和经前症状的影响,以及焦虑/压力症状和注意力控制。
    27名具有高于平均水平的经前或抑郁症状的参与者使用等待列表控制设计进行了为期4周的基于智能手机的光电体积描记术HRVB干预。在干预前后进行了实验室会议,相隔4周。评估包括静息性迷走神经介导的心率变异性(vmHRV),通过修订的注意力网络测试(ANT-R)进行注意力控制,用BDI-II问卷评估抑郁症状,和使用DASS问卷测量的压力/焦虑症状。如果适用,通过PAF问卷记录经前症状。数据分析采用线性混合模型。
    我们观察到经前的改善,抑郁,和焦虑/压力症状,以及ANT-R在干预期间的执行功能评分,而不是在等待列表阶段。然而,我们没有发现vmHRV或ANT-R的定向评分有明显变化。
    这些发现很有希望,无论是基于智能手机的HRVB的有效性还是其缓解经前症状的潜力。然而,提供关于使用HRVB改善经前症状的可靠建议,需要更大样本量的进一步研究来复制这些效应.
    UNASSIGNED: Heart rate variability biofeedback (HRVB) is a well-studied intervention known for its positive effects on emotional, cognitive, and physiological well-being, including relief from depressive symptoms. However, its practical use is hampered by high costs and a lack of trained professionals. Smartphone-based HRVB, which eliminates the need for external devices, offers a promising alternative, albeit with limited research. Additionally, premenstrual symptoms are highly prevalent among menstruating individuals, and there is a need for low-cost, accessible interventions with minimal side effects. With this pilot study, we aim to test, for the first time, the influence of smartphone-based HRVB on depressive and premenstrual symptoms, as well as anxiety/stress symptoms and attentional control.
    UNASSIGNED: Twenty-seven participants with above-average premenstrual or depressive symptoms underwent a 4-week photoplethysmography smartphone-based HRVB intervention using a waitlist-control design. Laboratory sessions were conducted before and after the intervention, spaced exactly 4 weeks apart. Assessments included resting vagally mediated heart rate variability (vmHRV), attentional control via the revised attention network test (ANT-R), depressive symptoms assessed with the BDI-II questionnaire, and stress/anxiety symptoms measured using the DASS questionnaire. Premenstrual symptomatology was recorded through the PAF questionnaire if applicable. Data analysis employed linear mixed models.
    UNASSIGNED: We observed improvements in premenstrual, depressive, and anxiety/stress symptoms, as well as the Executive Functioning Score of the ANT-R during the intervention period but not during the waitlist phase. However, we did not find significant changes in vmHRV or the Orienting Score of the ANT-R.
    UNASSIGNED: These findings are promising, both in terms of the effectiveness of smartphone-based HRVB and its potential to alleviate premenstrual symptoms. Nevertheless, to provide a solid recommendation regarding the use of HRVB for improving premenstrual symptoms, further research with a larger sample size is needed to replicate these effects.
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  • 文章类型: Journal Article
    创伤性脑损伤(TBI)是一种复杂的疾病,与一系列持续的症状相关,包括头痛,认知功能障碍,精神疲劳,失眠,和情绪障碍。TBI相关症状的常规治疗可能不足,导致对互补和综合医学(CIM)方法的兴趣。这篇全面的文章考察了现有的关于CIM模式的文献,包括身心干预,针灸/指压,草药,营养补充剂,生物反馈,瑜伽,和太极拳治疗TBI后继发并发症。这篇文章强调了CIM模式的潜在好处和局限性,同时承认需要进一步研究,以更好地确定在这一特定人群中的疗效和安全性。
    Traumatic brain injury (TBI) is a complex condition associated with a range of persistent symptoms including headaches, cognitive dysfunction, mental fatigue, insomnia, and mood disorders. Conventional treatments for TBI-related symptoms can be insufficient, leading to interest in complementary and integrative medicine (CIM) approaches. This comprehensive article examines the existing literature on CIM modalities, including mind-body interventions, acupuncture/acupressure, herbal remedies, nutritional supplements, biofeedback, yoga, and tai chi in the context of managing secondary complications following TBI. The article highlights potential benefits and limitations of CIM modalities, while acknowledging the need for further research to better establish efficacy and safety in this specific population.
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  • 文章类型: Journal Article
    探索心理健康技术的新方法,这项研究阐明了外在感受(对外部世界的感知)之间的复杂相互作用,和内部感受(对内部世界的感知)。借鉴感官替代原则,我们研究了交互感受信号,尤其是呼吸,可以通过外在的方式传达,即视觉和听觉。为此,我们开发了一个独特的,身临其境的多感官环境,将呼吸信号实时转化为动态的视觉和听觉刺激。通过使用一系列各种心理评估来评估该系统,研究结果表明,参与者的相互感受感显著增加,流动状态增强,意味着沉浸式和积极的参与体验。此外,这两个变量之间的相关性出现了,揭示了流动状态和感知力之间的双向增强。我们的研究是第一个提出了一种感官替代方法,用于在内部感觉和外部感觉之间进行替代,特别是作为心理健康干预的变革方法,为未来的研究铺平了道路。
    Exploring a novel approach to mental health technology, this study illuminates the intricate interplay between exteroception (the perception of the external world), and interoception (the perception of the internal world). Drawing on principles of sensory substitution, we investigated how interoceptive signals, particularly respiration, could be conveyed through exteroceptive modalities, namely vision and hearing. To this end, we developed a unique, immersive multisensory environment that translates respiratory signals in real-time into dynamic visual and auditory stimuli. The system was evaluated by employing a battery of various psychological assessments, with the findings indicating a significant increase in participants\' interoceptive sensibility and an enhancement of the state of flow, signifying immersive and positive engagement with the experience. Furthermore, a correlation between these two variables emerged, revealing a bidirectional enhancement between the state of flow and interoceptive sensibility. Our research is the first to present a sensory substitution approach for substituting between interoceptive and exteroceptive senses, and specifically as a transformative method for mental health interventions, paving the way for future research.
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  • 文章类型: Journal Article
    交互感受障碍越来越多地与许多身心健康状况有关。因此,有针对性的治疗性干预措施,以相互感受缺陷为目标。心率和心率变异性生物反馈治疗(HR(V)-BF),干预措施,训练个人调节他们的心血管信号,并通过呼吸将这些信号限制在最佳参数内,可以通过刺激迷走神经增强感觉通路的功能。因此,这篇叙述性系统综述试图综合文献的现状,关于HR(V)-BF作为跨行为的交互感受干预的潜力,与相互感觉相关的生理和神经结果测量。总的来说,这篇综述包括77篇论文,大多数人使用生理结果测量。总的来说,在HR(V)-BF后结局指标的改善方面,研究结果喜忧参半。然而,趋势表明,当采用共振频率呼吸和高强度治疗方案时,对与相互感觉相关的措施的影响更强。基于这些发现,我们提出了一个三阶段模型,通过该模型,HR(V)-BF可以改善互感,该模型借鉴了互感推理和预测编码的原理。此外,我们为未来的研究提供了具体的方向,这将有助于推进当前的知识状态。
    Interoceptive dysfunctions are increasingly implicated in a number of physical and mental health conditions. Accordingly, there is a pertinent need for therapeutic interventions which target interoceptive deficits. Heartrate and heartrate variability biofeedback therapy (HR(V)-BF), interventions which train individuals to regulate their cardiovascular signals and constrain these within optimal parameters through breathing, could enhance the functioning of interoceptive pathways via stimulation of the vagus nerve. Consequently, this narrative systematic review sought to synthesise the current state of the literature with regard to the potential of HR(V)-BF as an interoceptive intervention across behavioural, physiological and neural outcome measures related to interoception. In total, 77 papers were included in this review, with the majority using physiological outcome measures. Overall, findings were mixed with respect to improvements in the outcome measures after HR(V)-BF. However, trends suggested that effects on measures related to interoception were stronger when resonance frequency breathing and an intense treatment protocol were employed. Based on these findings, we propose a three-stage model by which HR(V)-BF may improve interoception which draws upon principles of interoceptive inference and predictive coding. Furthermore, we provide specific directions for future research, which will serve to advance the current knowledge state.
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  • 文章类型: Journal Article
    背景:帕金森病(PD)患者表现出异常的步态模式,影响了他们的独立性和生活质量。在所有由PD引起的步态改变中,减少步长,节奏增加,在载荷响应和推离阶段,地面反作用力的减少是最常见的。可穿戴生物反馈技术提供了提供与特定步态事件或步态表现相关的单模态或多模态刺激的可能性。从而促进受试者对步态障碍的认识。此外,步态康复在临床和家庭环境中的便携性和适用性提高了PD管理的效率.可穿戴式振动触觉双向接口(BI)是一种生物反馈设备,旨在实时提取步态特征,并与特定的步态阶段同步在PD受试者的腰部提供定制的振动触觉刺激。这项研究的目的是测量BI对步态参数的影响,通常会受到典型的缓慢运动步态的影响,并评估其在临床实践中的可用性和安全性。
    方法:在本例系列中,7名受试者(年龄:70.4±8.1岁;H&Y:2.7±0.3)使用了BI,并在10米人行道(10mWT)和两分钟步行测试(2MWT)上进行了测试,作为训练前(Pre-trn)和训练后(Post-trn)评估。步态测试在(Bf)和没有(No-Bf)生物反馈刺激激活的情况下以随机顺序进行。所有受试者进行了三个40分钟的训练课程,以在步行活动中熟悉BI。步态参数的描述性分析(即,步态速度,步长,节奏,步行距离,双重支持阶段)进行。双侧Wilcoxon符号检验用于评估Bf和No-Bf评估之间的差异(p<0.05)。
    结果:训练后受试者提高了步态速度(Pre-trn_No-Bf:0.72(0.59,0.72)m/sec;Post-trn_Bf:0.95(0.69,0.98)m/sec;p=0.043)和步长(Pre-trn_No-Bf:0.87(0.81,0.96)米;在使用生物反馈期间同样,受试者的步行距离改善(Pre-trn_No-Bf:97.5(80.3,110.8)米;Post-trn_Bf:118.5(99.3,129.3)米;p=0.028),并且双支撑阶段的持续时间减少(Pre-trn_No-Bf:29.7(26.8,31.7)%;Post-trn_Bf:27.2(2MW在Pre-trn时,以节奏(Pre-trn_No-Bf:108(103.8,116.7)步/分钟;Pre-trn_Bf:101.4(96.3,111.4)步/分钟;p=0.028)检测到BI的即时效果,和步行距离在后trn(后trn_No-Bf:112.5(97.5,124.5)米;后trn_Bf:118.5(99.3,129.3)米;p=0.043)。五个受试者的SUS得分为77.5,两个受试者的SUS得分为80.3。在安全方面,所有受试者均完成方案,未发生任何不良事件.
    结论:BI对于PD使用者似乎是可用和安全的。在提供详细结果的临床步行测试期间已经测量了时间步态参数。短期的BI训练表明PD患者的步态模式有所改善。这项研究为未来将BI整合为PD患者的临床评估和康复工具提供了初步支持。在医院和远程环境中。
    背景:研究方案已注册(DGDMF。VI/P/I.5.I.m.2/2019/1297),并由意大利卫生部医疗器械和药学服务总局以及伦巴第大区伦理委员会批准(米兰,意大利)。
    BACKGROUND: People with Parkinson\'s Disease (PD) show abnormal gait patterns compromising their independence and quality of life. Among all gait alterations due to PD, reduced step length, increased cadence, and decreased ground-reaction force during the loading response and push-off phases are the most common. Wearable biofeedback technologies offer the possibility to provide correlated single or multi-modal stimuli associated with specific gait events or gait performance, hence promoting subjects\' awareness of their gait disturbances. Moreover, the portability and applicability in clinical and home settings for gait rehabilitation increase the efficiency in the management of PD. The Wearable Vibrotactile Bidirectional Interface (BI) is a biofeedback device designed to extract gait features in real-time and deliver a customized vibrotactile stimulus at the waist of PD subjects synchronously with specific gait phases. The aims of this study were to measure the effect of the BI on gait parameters usually compromised by the typical bradykinetic gait and to assess its usability and safety in clinical practice.
    METHODS: In this case series, seven subjects (age: 70.4 ± 8.1 years; H&Y: 2.7 ± 0.3) used the BI and performed a test on a 10-meter walkway (10mWT) and a two-minute walk test (2MWT) as pre-training (Pre-trn) and post-training (Post-trn) assessments. Gait tests were executed in random order with (Bf) and without (No-Bf) the activation of the biofeedback stimulus. All subjects performed three training sessions of 40 min to familiarize themselves with the BI during walking activities. A descriptive analysis of gait parameters (i.e., gait speed, step length, cadence, walking distance, double-support phase) was carried out. The 2-sided Wilcoxon sign-test was used to assess differences between Bf and No-Bf assessments (p < 0.05).
    RESULTS: After training subjects improved gait speed (Pre-trn_No-Bf: 0.72(0.59,0.72) m/sec; Post-trn_Bf: 0.95(0.69,0.98) m/sec; p = 0.043) and step length (Pre-trn_No-Bf: 0.87(0.81,0.96) meters; Post-trn_Bf: 1.05(0.96,1.14) meters; p = 0.023) using the biofeedback during the 10mWT. Similarly, subjects\' walking distance improved (Pre-trn_No-Bf: 97.5 (80.3,110.8) meters; Post-trn_Bf: 118.5(99.3,129.3) meters; p = 0.028) and the duration of the double-support phase decreased (Pre-trn_No-Bf: 29.7(26.8,31.7) %; Post-trn_Bf: 27.2(24.6,28.7) %; p = 0.018) during the 2MWT. An immediate effect of the BI was detected in cadence (Pre-trn_No-Bf: 108(103.8,116.7) step/min; Pre-trn_Bf: 101.4(96.3,111.4) step/min; p = 0.028) at Pre-trn, and in walking distance at Post-trn (Post-trn_No-Bf: 112.5(97.5,124.5) meters; Post-trn_Bf: 118.5(99.3,129.3) meters; p = 0.043). SUS scores were 77.5 in five subjects and 80.3 in two subjects. In terms of safety, all subjects completed the protocol without any adverse events.
    CONCLUSIONS: The BI seems to be usable and safe for PD users. Temporal gait parameters have been measured during clinical walking tests providing detailed outcomes. A short period of training with the BI suggests improvements in the gait patterns of people with PD. This research serves as preliminary support for future integration of the BI as an instrument for clinical assessment and rehabilitation in people with PD, both in hospital and remote environments.
    BACKGROUND: The study protocol was registered (DGDMF.VI/P/I.5.i.m.2/2019/1297) and approved by the General Directorate of Medical Devices and Pharmaceutical Service of the Italian Ministry of Health and by the ethics committee of the Lombardy region (Milan, Italy).
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