震动触觉反馈治疗成人胫骨截肢的安全性和有效性：一项随机对照交叉试验

IF 1.4 3区医学 Q4 ENGINEERING, BIOMEDICAL

Clinical Biomechanics Pub Date : 2025-02-10 DOI:10.1016/j.clinbiomech.2025.106443

Harald Penasso , Gerfried Peternell , Rainer Schultheis , Aaron Pitschl , Ruth Leskovar , Alexander Gardetto , Jennifer Ernst , Karin Schmid-Zalaudek , Wolfgang Schaden

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引用次数: 0

摘要

下肢截肢患者面临着疼痛、社会融合和分散注意力安全行走的挑战。触觉反馈系统旨在通过促进假肢的实用性和具体化来改善感觉和康复。非侵入性振动触觉反馈装置Suralis®（奥地利维也纳的Saphenus医疗技术公司）旨在改善步态、姿势控制和疼痛治疗。这项随机对照交叉试验研究了振动触觉地面接触反馈对单侧经胫截肢成人无目标神经再植的步态表现和生活质量的60天影响。方法在非盲法干预期前后进行步态评估，并将干预期内的变化与不干预的对照组进行比较，中间间隔一周的洗脱期。主要替代结果是受影响的腿部站立时间，次要结果测量包括器械步行速度和四平方步测试。该试验在COVID-19大流行期间招募了18名参与者，由于招募和替代主要结局腿间站立时间差的完整性方面的限制，该试验提前结束。研究结果：五名参与者提前结束了研究，退出与不良事件无关，其中一人经历了注意力集中困难。对13名参与者的分析表明，行走速度低于1.41 ms−1 [1.34 ms−1,1.49 ms−1][95%最高密度间隔]、腿部站立时间高于0.64 s [0.58 s， 0.69 s]的参与者反应最积极。四平方步检验次数具有最大的期内效应量(平均0.89；[0.44, 1.34]为0.5 s [0 s， 1 s]改善)，其次是周期1 (- 0.37；[−0.56,−0.18])和治疗(0.28；[0.095, 0.46])。受影响的腿站立时间没有变化(0.21；[−0.26,0.66])。尽管存在学习效应，但振动触觉反馈对慢速行走参与者的功能平衡和步态表现有小的积极影响。试验注册由奥地利工人赔偿委员会AUVA资助并由Saphenus Medical Technology支持的试验已在临床试验网站（clinicaltrials.gov）上进行了回顾性注册(注册号：NCT05895253;注册日期：2023年5月19日)，此前由于COVID - 19大流行期间参与者数量有限而提前终止。

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Safety and efficacy of vibrotactile feedback for adults with transtibial amputation: A randomized controlled cross-over trial

Background

Pain, social integration, and walking safely with divided attention challenge people with lower-limb amputation. Tactile feedback systems aim to improve sensations and rehabilitation by facilitating prosthesis utility and embodiment. The non-invasive vibrotactile feedback device Suralis® (Saphenus Medical Technology, Vienna, Austria) aims to improve gait, postural control, and pain treatment. This randomized controlled cross-over trial investigated 60-day effects of vibrotactile ground-contact feedback on gait performance and quality of life in adults with unilateral transtibial amputation without targeted reinnervation.

Methods

We conducted gait assessments before and after the unblinded intervention period and compared within-period changes to the control period without intervention, separated by a one-week washout. The primary outcome substitute was affected-leg stance time, and secondary outcome measures included instrumented-walkway gait speed and four-square-step-test. The trial enrolled 18 participants during the COVID-19 pandemic and ended prematurely due to limitations in recruitment and integrity of the substituted primary outcome between-leg stance time difference.

Findings

Five participants ended the study prematurely, the dropouts were unrelated to adverse events where one experienced concentration difficulties. Analyzing 13 participants showed that participants walking slower than 1.41 ms⁻¹ [1.34 ms⁻¹, 1.49 ms⁻¹] [95 % highest-density interval] with affected-leg stance times above 0.64 s [0.58 s, 0.69 s] responded most positively. Four-square-step-test times had the largest within-period effect size (mean 0.89; [0.44, 1.34] for 0.5 s [0 s, 1 s] improvement), followed by period-one (−0.37; [−0.56, −0.18]), and treatment (0.28; [0.095, 0.46]). Affected-leg stance time did not change (0.21; [−0.26, 0.66]).

Interpretation

Despite the learning effects present, vibrotactile feedback had a small positive effect on functional balance and gait performance in slower-walking participants.

Trial Registration

The trial funded by the Austrian workers’ compensation board AUVA and supported by Saphenus Medical Technology was retrospectively registered on clinicaltrials.gov (no. NCT05895253; registration date: 19.05.2023) after a premature termination due to the limited availability of participants during the COVID 19 pandemic.

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来源期刊

Clinical Biomechanics 医学-工程：生物医学

CiteScore

3.30

自引率

5.60%

发文量

189

审稿时长

12.3 weeks

期刊介绍： Clinical Biomechanics is an international multidisciplinary journal of biomechanics with a focus on medical and clinical applications of new knowledge in the field. The science of biomechanics helps explain the causes of cell, tissue, organ and body system disorders, and supports clinicians in the diagnosis, prognosis and evaluation of treatment methods and technologies. Clinical Biomechanics aims to strengthen the links between laboratory and clinic by publishing cutting-edge biomechanics research which helps to explain the causes of injury and disease, and which provides evidence contributing to improved clinical management. A rigorous peer review system is employed and every attempt is made to process and publish top-quality papers promptly. Clinical Biomechanics explores all facets of body system, organ, tissue and cell biomechanics, with an emphasis on medical and clinical applications of the basic science aspects. The role of basic science is therefore recognized in a medical or clinical context. The readership of the journal closely reflects its multi-disciplinary contents, being a balance of scientists, engineers and clinicians. The contents are in the form of research papers, brief reports, review papers and correspondence, whilst special interest issues and supplements are published from time to time. Disciplines covered include biomechanics and mechanobiology at all scales, bioengineering and use of tissue engineering and biomaterials for clinical applications, biophysics, as well as biomechanical aspects of medical robotics, ergonomics, physical and occupational therapeutics and rehabilitation.