Muscle StiffnessIASTM-GastroNCT06934694
Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion
A study testing Instrument-Assisted Soft Tissue Mobilization in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
Trial summary
This study will examine whether a technique called instrument-assisted soft tissue mobilization (IASTM) can reduce stiffness in the calf muscle (gastrocnemius) and improve ankle mobility. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Stiffness
- What is being tested?
- Instrument-Assisted Soft Tissue Mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Apr 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years
- Healthy individuals without current lower limb injury
- No history of surgery to the ankle, knee, or calf
- Able to perform the weight-bearing lunge test without assistance
- Willing to refrain from intense lower-limb exercise 24 hours before testing
Who cannot join
- Current or recent (past 3 months) lower limb musculoskeletal pain or injury
- Known neuromuscular or vascular disorders affecting the lower extremity
- Use of medications affecting muscle tone or flexibility within 48 hours prior to testing
- Previous adverse reactions to manual therapy or IASTM
- Skin lesions, bruising, or conditions over the gastrocnemius that contraindicate IASTM
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences, Izola
Izola, Municipality of Izola, 6310
About this study
Official title: Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Muscle Stiffness and Ankle Dorsiflexion Range of Motion
This study will examine whether a technique called instrument-assisted soft tissue mobilization (IASTM) can reduce stiffness in the calf muscle (gastrocnemius) and improve ankle mobility. Muscle stiffness will be measured using a specialized ultrasound method called shear-wave elastography, while ankle range of motion will be assessed using the weight-bearing lunge test. Healthy volunteers will participate in this study, and measurements will be taken before and after a single IASTM treatment. The aim is to determine if this manual therapy technique can produce immediate changes in muscle properties and joint flexibility.
Read the detailed description
This interventional study aims to evaluate the acute effects of instrument-assisted soft tissue mobilization (IASTM) on the stiffness of the gastrocnemius muscle and ankle dorsiflexion range of motion. Muscle stiffness will be quantified using shear-wave elastography (SWE), a non-invasive ultrasound technique that measures tissue mechanical properties in real time. Ankle dorsiflexion range of motion will be assessed using the weight-bearing lunge test with the knee extended, a reliable functional measure of ankle mobility.
Participants will undergo baseline measurements followed by a standardized IASTM intervention targeting the gastrocnemius muscle. Post-treatment assessments will be conducted immediately afterward to capture acute changes. The study is designed to improve understanding of how IASTM influences muscle mechanical properties and functional joint mobility. Findings may have implications for the clinical use of IASTM in both rehabilitation and performance contexts.
- Conditions
- Muscle Stiffness
- Being tested
- Instrument-Assisted Soft Tissue Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-Assisted Soft Tissue MobilizationDevice
Participants will receive a single session of instrument-assisted soft tissue mobilization (IASTM) applied to the gastrocnemius muscle using a stainless-steel instrument. The treatment consists of longitudinal and transverse strokes targeting both the medial and lateral heads of the muscle. The procedure will be performed by a trained clinician, following a standardized protocol lasting approximately 5 minutes. The goal is to induce mechanical and neuromodulatory effects on muscle tissue. This intervention is designed to assess acute changes in muscle stiffness (via shear-wave elastography) and ankle dorsiflexion range of motion (via the weight-bearing lunge test).
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | Participants in this arm will receive a single session of instrument-assisted soft tissue mobilization (IASTM) applied to the gastrocnemius muscle. The treatment will be performed using a standardized protocol that includes longitudinal and cross-friction strokes with a stainless-steel tool. The intervention is designed to target the superficial and deep layers of the gastrocnemius and will be delivered for a total of approximately 5 minutes. Post-treatment assessments of muscle stiffness and ankle dorsiflexion range of motion will be conducted immediately following the intervention. Receives: Device: Instrument-Assisted Soft Tissue Mobilization |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle stiffness
Stiffness of the gastrocnemius muscle will be measured using shear-wave elastography (SWE), a non-invasive ultrasound technique that quantifies the shear modulus of soft tissue. Measurements will be performed with the participant in a prone position, with the ankle in a standardized neutral position, to ensure consistency. The shear modulus (in kilopascals) will be used as the primary metric of muscle stiffness.
Time Frame:
Measured: Baseline and Immediately Post-Intervention
Secondary outcomes (1)
Ankle Dorsiflexion Range of Motion
Ankle dorsiflexion range of motion will be assessed using the weight-bearing lunge test with the knee extended. The distance from the great toe to the wall will be recorded at the point where the heel remains in contact with the floor while the knee touches the wall. This test is a reliable and functional assessment of gastrocnemius-related ankle flexibility.
Measured: Baseline and Immediately Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start24 Apr 2025
- Primary completion30 May 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StiffnessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Žiga Kozinc, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934694
- Sponsor's protocol ID
- IASTM_Gastro
- Acronym
- IASTM-Gastro
- Status last verified
- May 2026
- First submitted
- 11 Apr 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Muscle Stiffness and Ankle Dorsiflexion Range of Motion
- ClinicalTrials.gov ID
- NCT06934694
- Acronym / sponsor ID
- IASTM-Gastro / IASTM_Gastro
- Conditions
- Muscle Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 18 Apr 2025 (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.
This study will examine whether a technique called instrument-assisted soft tissue mobilization (IASTM) can reduce stiffness in the calf muscle (gastrocnemius) and improve ankle mobility. Muscle stiffness will be measured using a specialized ultrasound method called shear-wave elastography, while ankle range of motion will be assessed using the weight-bearing lunge test. Healthy volunteers will participate in this study, and measurements will be taken before and after a single IASTM treatment. The aim is to determine if this manual therapy technique can produce immediate changes in muscle properties and joint flexibility.
Detailed description
This interventional study aims to evaluate the acute effects of instrument-assisted soft tissue mobilization (IASTM) on the stiffness of the gastrocnemius muscle and ankle dorsiflexion range of motion. Muscle stiffness will be quantified using shear-wave elastography (SWE), a non-invasive ultrasound technique that measures tissue mechanical properties in real time. Ankle dorsiflexion range of motion will be assessed using the weight-bearing lunge test with the knee extended, a reliable functional measure of ankle mobility.
Participants will undergo baseline measurements followed by a standardized IASTM intervention targeting the gastrocnemius muscle. Post-treatment assessments will be conducted immediately afterward to capture acute changes. The study is designed to improve understanding of how IASTM influences muscle mechanical properties and functional joint mobility. Findings may have implications for the clinical use of IASTM in both rehabilitation and performance contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Device: Instrument-Assisted Soft Tissue MobilizationParticipants in this arm will receive a single session of instrument-assisted soft tissue mobilization (IASTM) applied to the gastrocnemius muscle. The treatment will be performed using a standardized protocol that includes longitudinal and cross-friction strokes with a stainless-steel tool. The intervention is designed to target the superficial and deep layers of the gastrocnemius and will be delivered for a total of approximately 5 minutes. Post-treatment assessments of muscle stiffness and ankle dorsiflexion range of motion will be conducted immediately following the intervention. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 45 years
- Healthy individuals without current lower limb injury
- No history of surgery to the ankle, knee, or calf
- Able to perform the weight-bearing lunge test without assistance
- Willing to refrain from intense lower-limb exercise 24 hours before testing
Key exclusion criteria (6 listed)
- Current or recent (past 3 months) lower limb musculoskeletal pain or injury
- Known neuromuscular or vascular disorders affecting the lower extremity
- Use of medications affecting muscle tone or flexibility within 48 hours prior to testing
- Previous adverse reactions to manual therapy or IASTM
- Skin lesions, bruising, or conditions over the gastrocnemius that contraindicate IASTM
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 |
|---|---|---|
| Instrument-Assisted Soft Tissue MobilizationParticipants will receive a single session of instrument-assisted soft tissue mobilization (IASTM) applied to the gastrocnemius muscle using a stainless-steel instrument. The treatment consists of longitudinal and transverse strokes targeting both the medial and lateral heads of the muscle. The procedure will be performed by a trained clinician, following a standardized protocol lasting approximately 5 minutes. The goal is to induce mechanical and neuromodulatory effects on muscle tissue. This intervention is designed to assess acute changes in muscle stiffness (via shear-wave elastography) and ankle dorsiflexion range of motion (via the weight-bearing lunge test). | Device | IASTM |
Primary outcome
Muscle stiffness
Time frame: Baseline and Immediately Post-Intervention
Stiffness of the gastrocnemius muscle will be measured using shear-wave elastography (SWE), a non-invasive ultrasound technique that quantifies the shear modulus of soft tissue. Measurements will be performed with the participant in a prone position, with the ankle in a standardized neutral position, to ensure consistency. The shear modulus (in kilopascals) will be used as the primary metric of muscle stiffness. Time Frame:
1 secondary outcome
Ankle Dorsiflexion Range of Motion
Time frame: Baseline and Immediately Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-Assisted Soft Tissue Mobilization in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle stiffness (time frame: Baseline and Immediately Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.