Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion
IASTM-Gastro
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedStudy Start
First participant enrolled
April 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2025
CompletedMay 4, 2026
May 1, 2026
1 month
April 11, 2025
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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:
Baseline and Immediately Post-Intervention
Secondary Outcomes (1)
Ankle Dorsiflexion Range of Motion
Baseline and Immediately Post-Intervention
Study Arms (2)
IASTM
EXPERIMENTALParticipants 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 INTERVENTIONInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Primorska, Faculty of Health Sciences, Izola
Izola, Municipality of Izola, 6310, Slovenia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Assistant professor
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 18, 2025
Study Start
April 24, 2025
Primary Completion
May 30, 2025
Study Completion
June 15, 2025
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share