鞋垫对足底筋膜炎的作用 (Insoles)
2026年8月26日 更新者:Hande YAZICI、Medipol University
鞋垫对足底筋膜炎肌肉激活和步态参数的影响
它的目的是调查两种由不同材料制成的个性化鞋垫,旨在减轻足底筋膜炎患者的疼痛,在 3 个月的随访中对肌肉激活和步态参数的影响。
研究概览
详细说明
足底筋膜炎(PF)是筋膜炎症增厚后发生的疾病,筋膜起源于跟骨内侧结节,行于足底内侧,具有较厚的纤维带结构。
它的目的是调查两种由不同材料制成的个性化鞋垫,旨在减轻足底筋膜炎患者的疼痛,在 3 个月的随访中对肌肉激活和步态参数的影响。
该研究的参与者将由年龄在 18 至 65 岁之间的男性和女性组成,他们被专科医生诊断为足底筋膜炎,向假肢矫形中心 (POMER) 申请个性化鞋垫处方,并自愿参加参与研究。将为参与者提供人口统计信息、足部功能评估、足底压力分析、步态评估、肌肉活动评估和满意度评估。
足部功能指数 (FFI) 将用于评估足底筋膜炎患者的足部功能。
将使用 EsCoSCAN® 足底压力评估装置的 Tekscan 软件进行足底压力分布分析。
个体的足底压力分析和身体评估将通过计算机辅助设计和计算机辅助制造(CAD-CAM)方法进行和制作。
肌肉激活数据将使用 BIOSIGNALSPLUX Researcher Kit 品牌 EMG 设备进行记录。
将使用满意度评估-矫形假肢用户调查问卷(OPKA-M)。
感官评估将使用 Semmes Weinstein 单纤维进行评估。
所有数据将通过统计分析方法进行评估。
研究类型
介入性
注册 (实际的)
41
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Istanbul
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Beykoz、Istanbul、土耳其(türkiye)、34815
- Istanbul Medipol University, Prosthetics and Orthotics Center (POMER)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准:
- 年龄在18-65岁之间,
- 被诊断出患有足底筋膜炎,
- 被规定定制鞋垫,
- 投诉时间至少3个月,
- 足跟痛主诉位于足底内侧跟骨结节,
- 疼痛症状在早上迈出的第一步或休息后迈出的步数中最为明显,
- 在初始评估中 Roles 和 Maudsley 得分为 3 或 4
排除标准:
- 体重指数大于 30 kg/m2,
- 患有除足底筋膜炎以外的任何心肺、皮肤病、神经或骨科问题,
- 有足部或踝部手术史,
- 使用辅助器具(助行器、加拿大人等)
- 没有使用合适的鞋子,
- 有认知、精神和/或心理问题
- 怀孕了
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:CNC-Milled EVA Insole
Participants assigned to this active-comparator arm received a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling and were instructed to use the assigned orthosis for 12 weeks.
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A custom-made insole was individually manufactured from ethylene-vinyl acetate (EVA) using computer numerical control (CNC) milling.
Participants used the assigned insole for 12 weeks.
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实验性的:FDM 3D-Printed TPU Insole
Participants assigned to this experimental arm received a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing and were instructed to use the assigned orthosis for 12 weeks.
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A custom-made insole was individually manufactured from thermoplastic polyurethane (TPU) using fused deposition modelling (FDM) three-dimensional printing.
Participants used the assigned insole for 12 weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Gastrocnemius Muscle Activation During a Standardized 10-Metre Walking Task
大体时间:Baseline and Week 12
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Surface electromyography was recorded bilaterally from the gastrocnemius medialis and gastrocnemius lateralis muscles during a standardized 10-metre walking task.
The processed parameters included maximum EMG envelope amplitude and mean-maximum, minimum-peak and maximum-peak activation values normalized to maximum voluntary contraction (%MVC).
MVC recordings were obtained during standardized plantar-flexion and dorsiflexion tasks.
Higher %MVC values indicate greater muscle activation relative to MVC.
The 10-metre walk was used solely as the standardized task for EMG recording and was not evaluated as a walking-performance outcome.
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Baseline and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Affected Foot Loading Assessed by Static Pedobarography
大体时间:Baseline and Week 12
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Static pedobarography was performed during quiet standing to quantify plantar load distribution.
Rearfoot loading of the affected foot was expressed as a percentage of the total plantar load for that foot, ranging from 0% to 100%, with higher values indicating greater relative rearfoot loading.
Affected and unaffected feet were coded before analysis.
Because forefoot and rearfoot loading percentages are mathematically complementary, forefoot loading was not treated as a separate independent endpoint.
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Baseline and Week 12
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Change From Baseline in Foot-Related Function Assessed by the Foot Function Index
大体时间:Baseline and Week 12
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Foot-related function was evaluated using the 23-item Foot Function Index, comprising pain, disability and activity-limitation subscales.
Subscale and total scores are expressed on a scale from 0 to 100, with higher scores indicating greater pain, disability or activity limitation.
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Baseline and Week 12
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Change From Baseline in Pain Intensity Assessed by the Visual Analogue Scale
大体时间:Baseline and Week 12
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Pain intensity was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
First-step morning pain, pain during palpation of the plantar heel and pain associated with prolonged standing were recorded and analyzed as separate pain scores.
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Baseline and Week 12
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Change From Baseline in Plantar Heel Pressure Pain Threshold
大体时间:Baseline and Week 12
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Pressure pain threshold at the plantar heel was measured using a pressure algometer and expressed in kg/cm².
Higher values indicate a greater pressure pain threshold and lower pressure sensitivity.
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Baseline and Week 12
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Participant Satisfaction With the Assigned Insoles Assessed by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-2.0).
大体时间:Week 12
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Participant satisfaction was assessed at Week 12 using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
The 12-item instrument comprises eight items evaluating satisfaction with the assistive device and four items evaluating satisfaction with related services.
Each item is scored from 1 (not satisfied at all) to 5 (very satisfied).
Device, service and total QUEST scores are calculated by averaging the applicable item scores, with higher scores indicating greater satisfaction.
Participants also identify the three satisfaction items they consider most important; these responses were summarized descriptively.
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Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年12月16日
初级完成 (实际的)
2025年1月6日
研究完成 (实际的)
2026年7月21日
研究注册日期
首次提交
2024年8月19日
首先提交符合 QC 标准的
2024年8月19日
首次发布 (实际的)
2024年8月20日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- HYAZICI
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
No formal plan was established to share de-identified individual participant data with other researchers.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.