- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934694
Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion (IASTM-Gastro)
Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Muscle Stiffness and Ankle Dorsiflexion Range of Motion
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Municipality of Izola
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Izola, Municipality of Izola, Slovenia, 6310
- University of Primorska, Faculty of Health Sciences, Izola
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
|
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Experimental: IASTM
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.
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle stiffness
Time Frame: Baseline and Immediately Post-Intervention
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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: |
Baseline and Immediately Post-Intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle Dorsiflexion Range of Motion
Time Frame: Baseline and Immediately Post-Intervention
|
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.
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Baseline and Immediately Post-Intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IASTM_Gastro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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