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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mary Loghmani, PhD, PT
- 電話番号：3176910175
- メール：mloghman@iu.edu
研究連絡先のバックアップ
- 名前：Rachael Powell, DPT
- 電話番号：3173061072
- メール：racpowel@iu.edu
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Health and Human Sciences
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コンタクト：
- Rachael Powell, DPT
- 電話番号：3173061072
- メール：racpowel@iu.edu
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コンタクト：
- Mary T Loghmani, PhD, PT
- 電話番号：3176910175
- メール：mloghman@iu.edu
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主任研究者：
- Mary T Loghmani, PhD, PT
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT)
時間枠：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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Calf muscle stiffness
時間枠：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
時間枠：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
時間枠：Immediately before and after intervention at each session.
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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
時間枠：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
時間枠：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
時間枠：Before and after interventions at each session.
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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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-Reported Anxiety Level
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 32736
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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