Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy (TIRE)
2026年8月12日 更新者：Jennifer Xu
This study will evaluate the immediate effects of wearing textured insoles on gait, postural control, and sensorimotor function in adults with plantar fasciopathy.
Researchers will compare functional performance while participants wear textured insoles to determine whether this intervention may improve stability, movement and future studies of longer-term treatment.
研究概览
详细说明
Plantar fasciopathy is a common condition that causes heel pain and is associated with impaired sensorimotor function, altered gait, reduced balance and decreased physical function.
Current treatments primarily target symptom relief and do not directly address sensorimotor impairments.
Textured insoles provide sensory stimulation to the plantar surface of the foot and may improve balance, gait mechanics and functional performance by enhancing plantar cutaneous input.
This study will investigate the acute effects of textured insoles on gait, postural control and sensorimotor function in adults with plantar fasciopathy.
Results will provide preliminary evidence regarding the feasibility and potential effectiveness of textured insoles as a treatment strategy and inform future studies evaluating longer-term outcomes.
研究类型
介入性
注册 (估计的)
26
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。
学习联系方式
- 姓名：Jennifer Xu, PhD
- 电话号码：8593239850
- 邮箱：jen.xu@uky.edu
学习地点
-
-
Kentucky
-
Lexington、Kentucky、美国、40506
- University of Kentucky - Sports Medicine Research Institute
-
接触：
- Jennifer Xu, PhD
- 电话号码：8593239850
- 邮箱：jxu231@uky.edu
-
-
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
接受健康志愿者
不
描述
Inclusion Criteria:
- Diagnosis of plantar fasciopathy for at least 3 months
- Able to walk continuously at a self-selected pace for at least 20 minutes
- Able and willing to provide informed consent
Exclusion Criteria:
- Concomitant lower extremity injury (example fracture)
- History of lower extremity injury within the previous 6 months
- History of hip, knee, or ankle surgery involving bones, joints, ligaments, tendons, or cartilage.
- Any condition other than plantar fasciopathy that affects balance or plantar cutaneous sensation.
- Neurological deficits, vestibular disorders, visual disturbances, or other conditions that impair movement or sensory function.
- Pregnancy
- Unable to speak or understand English.
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：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Textured Insole
Participants will wear textured insoles while completing gait, postural control, and sensorimotor function assessments to evaluate the acute effects of the intervention on plantar fasciopathy.
|
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
|
|
假比较器：Smooth Insole
Participants will wear a smooth (non-textured) insole while completing the same assessments to serve as the comparison condition in the crossover study.
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A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
|
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 in Postural Control
大体时间：Baseline and immediately following completion of each intervention condition during the study visit
|
Postural control will be assessed while participants complete standardized balance testing under each study condition.
Performance will be compared between the textured insole and smooth insole conditions to evaluate the acute effects of textured insoles on postural control.
|
Baseline and immediately following completion of each intervention condition during the study visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Gait Characteristics
大体时间：Baseline and immediately following completion of each intervention condition during the study visit.
|
Gait characteristics will be assessed during walking trials under each study condition and compared between the textured and smooth insole conditions.
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Baseline and immediately following completion of each intervention condition during the study visit.
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Change in Plantar Sensation
大体时间：Baseline and immediately following completion of each intervention condition during the study visit.
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Plantar sensation will be assessed with the Semmes-Weinstein monofilaments.
The detection threshold will be the lightest weight monofilament (grams of force (gf)) that can be perceived by the participant.
Lower values indicate better plantar sensation.
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Baseline and immediately following completion of each intervention condition during the study visit.
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Change in Pressure-Pain Threshold
大体时间：Baseline and immediately following completion of each intervention condition during the study visit.
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Pressure-pain threshold will be assessed with an algometer.
The pressure-pain threshold will be measured in kg/cm2.
Higher values indicate better pressure-pain threshold.
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Baseline and immediately following completion of each intervention condition during the study visit.
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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。
赞助
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 (估计的)
2026年9月1日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年7月30日
首先提交符合 QC 标准的
2026年8月12日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 118998
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.