An interventional study of quantitative instrument-assisted soft tissue manipulation in Limited Ankle Dorsiflexion Range of Motion and Calf Muscle Tightness, sponsored by Indiana University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Indiana University · Not applicable, Interventional, and Basic science
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.
Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive higher-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold
Device: quantitative instrument-assisted soft tissue manipulation
Will receive a lower-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold
Device: quantitative instrument-assisted soft tissue manipulation
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.
Also known as: QSTM
Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT)
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).
Time frame: Immediately before and after intervention to each leg at each session.
Calf muscle stiffness
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.
Time frame: Immediately before and after intervention to each leg at each session.
pain pressure threshold
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.
Time frame: Immediately before and after intervention at each session.
Walking speed
Walking speed will be assessed during a standardized walking task and reported as walking velocity. Higher values indicate faster walking performance.
Time frame: Immediately before and after intervention at each session.
Vertical Jump Performance
Jump height will be recorded using standard equipment, with higher values indicating greater lower-extremity power and performance.
Time frame: Immediately before and after intervention at each session.
Self-reported Pain Level
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.
Time frame: Immediately before and after interventions to each leg at each session.
Self-reported function level
Function level will be assessed using a Visual Analog Scale (VAS), with higher scores indicating greater self-reported function.
Time frame: Before and after interventions at each session.
Self-Reported Anxiety Level
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.
Time frame: Immediately prior to intervention at each session.
Treatment Outcome Expectancy
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.
Time frame: Immediately prior to first intervention at first session
Treatment Pleasantness Rating
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.
Time frame: Immediately following each intervention session.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — 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.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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