Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
Dual Pathway Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Dose-Response Effects in the Calf-Foot Region: Mechanical and Contextual Contributions
The goal of this clinical trial is to learn how different levels of force applied during instrument-assisted soft tissue manipulation (IASTM), a common rehabilitation treatment, affect muscle and soft tissue function in healthy adults with limited ankle flexibility. The study will also examine whether participant expectations, treatment comfort, and other contextual factors influence treatment outcomes. The main questions it aims to answer are:
Do higher-force and lower-force IASTM treatments produce different changes in ankle flexibility, muscle stiffness, pressure pain sensitivity, walking performance, and jumping ability? How do participant expectations, anxiety, comfort, and treatment perceptions contribute to treatment outcomes?
Researchers will compare a higher-force IASTM treatment to a lower-force IASTM treatment to determine whether force dose influences physical and patient-reported outcomes.
Participants will:
Attend two study visits separated by a washout period of 3-7 days. Receive a lower-force IASTM treatment during one visit and a higher-force IASTM treatment during the other visit, in a randomly assigned order.
Complete questionnaires about expectations, anxiety, treatment comfort, and treatment experience.
Undergo assessments of ankle flexibility, calf muscle stiffness, sensitivity to pressure, walking speed, and lower-body performance before and after each treatment session.
The findings from this study will help researchers better understand how biomechanical and non-biomechanical factors contribute to the effects of soft tissue treatments and may help inform the development of more effective rehabilitation interventions.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mary Loghmani, PhD, PT
- 电话号码：3176910175
- 邮箱：mloghman@iu.edu
研究联系人备份
- 姓名：Rachael Powell, DPT
- 电话号码：3173061072
- 邮箱：racpowel@iu.edu
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University School of Health and Human Sciences
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接触：
- Rachael Powell, DPT
- 电话号码：3173061072
- 邮箱：racpowel@iu.edu
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接触：
- Mary T Loghmani, PhD, PT
- 电话号码：3176910175
- 邮箱：mloghman@iu.edu
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首席研究员：
- Mary T Loghmani, PhD, PT
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female
- Between the ages of 18-50 years old
- Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2
- A tight calf with limited ankle dorsiflexion range of motion: < 8-9 cm on weight-bearing lunge test (WBLT) indicating restricted ankle dorsiflexion and/or side to side difference of >1.5 cm due to muscular tightness.
Exclusion Criteria:
- Any known musculoskeletal pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or inflammatory conditions that may interfere with study participation.
- Ankle joint limitations due to intra-articular, capsular tightness, or post-fracture abnormalities.
- Any known cardiovascular, pulmonary, metabolic disease, or other co-morbidities that could interfere with the clinician's ability to perform basic IASTM stroke patterns to the calf or subject participation.
- Any narcotics, blood thinners, or other medications that could alter sensation, consciousness, or tendency to bruise/bleed.
- Any recent surgeries, medical conditions, or injuries that could interfere with treatment or ability to participate.
- Acute injuries, unhealed, acute or unstable conditions.
- Any known contraindications to instrument-assisted soft tissue manipulation of the lower extremity, including but not limited to open wounds, active infection, unhealed fracture, deep vein thrombosis, severe vascular disorders, bleeding disorders, anticoagulant therapy associated with increased bleeding risk, or other conditions that, in the judgment of the investigator, would make study participation unsafe.
- Current smoking or recreational/illicit drug use.
- Individuals who answer "Yes" to any of Questions 1-7 on the Physical Activity Readiness Questionnaire (PAR-Q) will be required to obtain written clearance from their physician or other qualified healthcare provider before participating in study procedures involving physical activity
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Higher-force IASTM
Will receive higher-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold |
Higher-Force Instrument-assisted soft tissue manipulation (IASTM) is applied to the calf-foot region using a force-sensing research instrument that provides real-time visual feedback to the clinician. A standardized treatment protocol is used, including consistent treatment duration, treatment area, stroke characteristics, and participant positioning. Force is maintained within a predefined higher-force target range based on participant tolerance within their comfort. Lower-Force IASTM is applied to the calf-foot region using the same force-sensing device and standardized treatment protocol. Force is maintained within a predefined lower-force target range to isolate the effects of force dose on study outcomes. The intervention is designed to evaluate force-dose effects while controlling other treatment variables.
其他名称：
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实验性的：Lower-force IASTM
Will receive a lower-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold |
Higher-Force Instrument-assisted soft tissue manipulation (IASTM) is applied to the calf-foot region using a force-sensing research instrument that provides real-time visual feedback to the clinician. A standardized treatment protocol is used, including consistent treatment duration, treatment area, stroke characteristics, and participant positioning. Force is maintained within a predefined higher-force target range based on participant tolerance within their comfort. Lower-Force IASTM is applied to the calf-foot region using the same force-sensing device and standardized treatment protocol. Force is maintained within a predefined lower-force target range to isolate the effects of force dose on study outcomes. The intervention is designed to evaluate force-dose effects while controlling other treatment variables.
其他名称：
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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 |
|---|---|---|
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Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT)
大体时间：Immediately before and after intervention to each leg at each session.
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Change in ankle dorsiflexion range of motion measured using the Weight-Bearing Lunge Test (WBLT) immediately following higher-force and lower-force instrument-assisted soft tissue manipulation (IASTM). |
Immediately before and after intervention to each leg at each session.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Calf muscle stiffness
大体时间：Immediately before and after intervention to each leg at each session.
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Calf muscle stiffness will be assessed using a handheld tissue stiffness measurement device. Higher values indicate greater resistance of the calf musculature to deformation, whereas lower values indicate reduced tissue stiffness. |
Immediately before and after intervention to each leg at each session.
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pain pressure threshold
大体时间：Immediately before and after intervention at each session.
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Pressure pain threshold will be assessed using a pressure algometer applied to the calf musculature. The measure represents the minimum pressure at which pressure sensation first becomes painful. Higher values indicate lower pain sensitivity. |
Immediately before and after intervention at each session.
|
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Walking speed
大体时间：Immediately before and after intervention at each session.
|
Walking speed will be assessed during a standardized walking task and reported as walking velocity. Higher values indicate faster walking performance. |
Immediately before and after intervention at each session.
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Vertical Jump Performance
大体时间：Immediately before and after intervention at each session.
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Jump height will be recorded using standard equipment, with higher values indicating greater lower-extremity power and performance. |
Immediately before and after intervention at each session.
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Self-reported Pain Level
大体时间：Immediately before and after interventions to each leg at each session.
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Pain intensity will be assessed using an 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores indicate greater pain intensity. |
Immediately before and after interventions to each leg at each session.
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Self-reported function level
大体时间：Before and after interventions at each session.
|
Function level will be assessed using a Visual Analog Scale (VAS), with higher scores indicating greater self-reported function. |
Before and after interventions at each session.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-Reported Anxiety Level
大体时间：Immediately prior to intervention at each session.
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Anxiety level will be assessed using a Visual Analog Scale (VAS), in which participants rate their current level of anxiety on a continuous scale. Higher scores indicate greater self-reported anxiety. |
Immediately prior to intervention at each session.
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Treatment Outcome Expectancy
大体时间：Immediately prior to first intervention at first session
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Treatment expectancy will be assessed using a participant-reported questionnaire that measures the extent to which participants expect the higher or lower force intervention to improve mobility, physical performance, and related outcomes. Higher scores indicate greater expectations of treatment benefit. |
Immediately prior to first intervention at first session
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Treatment Pleasantness Rating
大体时间：Immediately following each intervention session.
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Treatment pleasantness will be assessed using a participant-reported rating of the overall comfort and pleasantness of the intervention experience. Higher scores indicate a more favorable treatment experience. |
Immediately following each intervention session.
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 32736
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified individual participant data may be shared with other researchers in accordance with participant consent and institutional policies; however, specific plans for data sharing have not yet been determined.
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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