Limited Ankle Dorsiflexion Due to Calf Muscle TightnessNCT07921459
Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
A study testing quantitative instrument-assisted soft tissue manipulation in people with Limited Ankle Dorsiflexion Due to Calf Muscle Tightness, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
- What is being tested?
- quantitative instrument-assisted soft tissue manipulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University School of Health and Human Sciences
Indianapolis, Indiana, 46202
Mary T Loghmani, PhD, PT, 3176910175, mloghman@iu.edu
Rachael Powell, DPT, 3173061072, racpowel@iu.edu
About this study
Official title: 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?
Read more
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.
- Being tested
- quantitative instrument-assisted soft tissue manipulation
- Keywords
- muscle tightness, massage, calf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative instrument-assisted soft tissue manipulationDevice
Also called QSTM
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher-force IASTM | Experimental | Will receive higher-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold Receives: Device: quantitative instrument-assisted soft tissue manipulation |
| Lower-force IASTM | Experimental | Will receive a lower-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold Receives: Device: quantitative instrument-assisted soft tissue manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before and after intervention to each leg at each session.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after interventions at each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start6 Nov 2026 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limited Ankle Dorsiflexion Due to Calf Muscle TightnessStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary T. Loghmani, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921459
- Sponsor's protocol ID
- 32736
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Bhattacharjee A, Anwar S, Chien S, Loghmani MT. A Handheld Quantifiable Soft Tissue Manipulation Device for Tracking Real-Time Dispersive Force-Motion Patterns to Characterize Manual Therapy Treatment. IEEE Trans Biomed Eng. 2023 May;70(5):1553-1564. doi: 10.1109/TBME.2022.3222124. Epub 2023 Apr 20.
PubMed 36378798
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Pathway Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Dose-Response Effects in the Calf-Foot Region: Mechanical and Contextual Contributions
- ClinicalTrials.gov ID
- NCT07921459
- Acronym / sponsor ID
- 32736
- Keywords
- muscle tightness, massage, calf
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher-force IASTM | Experimental | Device: quantitative instrument-assisted soft tissue manipulationWill receive higher-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold |
| Lower-force IASTM | Experimental | Device: quantitative instrument-assisted soft tissue manipulationWill receive a lower-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantitative instrument-assisted soft tissue manipulationAlso: QSTMHigher-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. | Device | Higher-force IASTM, Lower-force IASTM |
Primary outcome
Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT)
Time frame: Immediately before and after intervention to each leg at each session.
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).
6 secondary outcomes
Calf muscle stiffness
Time frame: Immediately before and after intervention to each leg at each session.
pain pressure threshold
Time frame: Immediately before and after intervention at each session.
Walking speed
Time frame: Immediately before and after intervention at each session.
Vertical Jump Performance
Time frame: Immediately before and after intervention at each session.
Self-reported Pain Level
Time frame: Immediately before and after interventions to each leg at each session.
Self-reported function level
Time frame: Before and after interventions at each session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 36378798Bhattacharjee A, Anwar S, Chien S, Loghmani MT. A Handheld Quantifiable Soft Tissue Manipulation Device for Tracking Real-Time Dispersive Force-Motion Patterns to Characterize Manual Therapy Treatment. IEEE Trans Biomed Eng. 2023 May;70(5):1553-1564. doi: 10.1109/TBME.2022.3222124. Epub 2023 Apr 20.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quantitative instrument-assisted soft tissue manipulation in people with Limited Ankle Dorsiflexion Due to Calf Muscle Tightness, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Loghmani, PhD, PT (3176910175, mloghman@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT) (time frame: Immediately before and after intervention to each leg at each session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.