Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 50 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Male or female
2. Between the ages of 18-50 years old
3. Body Mass Index (BMI) ≥ 18.5 kg/m2 but \<30 kg/m2
4. 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:

1. Any known musculoskeletal pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or inflammatory conditions that may interfere with study participation.
2. Ankle joint limitations due to intra-articular, capsular tightness, or post-fracture abnormalities.
3. 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.
4. Any narcotics, blood thinners, or other medications that could alter sensation, consciousness, or tendency to bruise/bleed.
5. Any recent surgeries, medical conditions, or injuries that could interfere with treatment or ability to participate.
6. Acute injuries, unhealed, acute or unstable conditions.
7. 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.
8. Current smoking or recreational/illicit drug use.
9. 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Indiana University

Study start

Nov 6, 2026 Estimated

Primary completion

Oct 25, 2027 Estimated

Study completion

2027-12 Estimated

First posted

Nov 6, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts