Immediate Effects of Two IASTM Tools on Lower-Leg Tissue Stiffness and Ankle Mobility

NCT07822594 | Not Yet Recruiting

• 1 other identifier: UPFVZ-IASTM-2026
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will investigate the immediate effects of instrument-assisted soft tissue mobilization (IASTM) performed with two different commercially available tools on posterior lower-leg tissue stiffness and ankle dorsiflexion range of motion in healthy young adults. Participants will be randomly allocated to one of three parallel groups: IASTM using a higher-cost tool, IASTM using a lower-cost tool, or passive rest without IASTM. Tissue stiffness at predefined posterior lower-leg sites and ankle dorsiflexion range of motion will be assessed before and immediately after the intervention or equivalent rest period. A single lower limb will be assessed in each participant. Participants receiving IASTM will additionally rate the pleasantness of the intervention and their perceived relaxation after the intervention. The study will determine whether IASTM produces immediate changes in tissue stiffness and ankle dorsiflexion compared with passive rest and whether these effects differ between the two IASTM tools.

Conditions

Muscle Stiffness

Keywords

instrument-assisted soft tissue mobilization; soft tissue mobilization; muscle stiffness; ankle dorsiflexion; MyotonPRO; gastrocnemius; soleus; Achilles tendon; range of motion

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Medial Gastrocnemius Stiffness

  Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.

  Baseline and immediately after the 6-minute intervention or rest period

• Change From Baseline in Lateral Gastrocnemius Stiffness

  Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.

  Baseline and immediately after the 6-minute intervention or rest period

• Change From Baseline in Soleus Stiffness

  Tissue stiffness will be measured using MyotonPRO and expressed in N/m. The measurement site will be located medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. Two consecutive measurements will be obtained and averaged.

  Baseline and immediately after the 6-minute intervention or rest period

• Change From Baseline in Achilles Tendon Stiffness

  Achilles tendon stiffness will be measured using MyotonPRO and expressed in N/m at a predefined site 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained and averaged.

  Baseline and immediately after the 6-minute intervention or rest period

• Change From Baseline in Ankle Dorsiflexion Range of Motion

  Ankle dorsiflexion range of motion will be measured in degrees using a digital inclinometer positioned on the lateral aspect of the lower leg during a weight-bearing lunge with the assessed knee maintained in extension and the heel in contact with the floor.

  Baseline and immediately after the 6-minute intervention or rest period

Secondary Outcomes (2)

• Perceived Pleasantness of IASTM

  Immediately after the 6-minute IASTM intervention

• Perceived Relaxation After IASTM

  Immediately after the 6-minute IASTM intervention

Study Arms (3)

Higher-Cost IASTM

EXPERIMENTAL

Participants will receive a standardized six-minute IASTM intervention to the posterior lower-leg region using the higher-cost IASTM tool. The first minute will include familiarization, desensitization, and application of IASTM cream, followed by five minutes of standardized treatment.

Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool

Lower-Cost IASTM

ACTIVE COMPARATOR

Participants will receive the same standardized six-minute IASTM intervention to the posterior lower-leg region using the lower-cost IASTM tool. Treatment duration, technique, instrument angle, treated region, and intensity will be matched to the higher-cost IASTM group.

Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool

Passive Control

NO INTERVENTION

Participants will rest passively for six minutes without receiving IASTM. Measurements will be performed before and immediately after the rest period using the same procedures as in the intervention groups.

Interventions

Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool PROCEDURE

A six-minute standardized IASTM intervention applied to the posterior lower-leg region using a higher-cost IASTM tool. The first minute consists of familiarization, desensitization, and application of IASTM cream, followed by five minutes of long gliding strokes along the direction of the muscle fibers. The instrument is held at approximately 45 degrees and treatment intensity is adjusted to slight pain or moderate discomfort.

Higher-Cost IASTM

Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool PROCEDURE

The same six-minute standardized IASTM intervention as in the higher-cost tool condition, performed using a lower-cost IASTM tool. Treatment duration, treated region, stroke direction, instrument angle, and target intensity are standardized between the two IASTM interventions.

Lower-Cost IASTM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 40 years
• Healthy volunteer
• Willing and able to provide written informed consent

You may not qualify if:

• Current or previous lower-limb injury
• Neuromuscular disorder
• Neurological disorder

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences, Izola

Izola, Urban Municipality of Koper, 6310, Slovenia

Location

Central Study Contacts

Žiga Kozinc, PhD

CONTACT

040161503; ziga.kozinc@s2p.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof. dr.

Model Details: Participants will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive rest. One lower limb per participant will be assessed before and immediately after the intervention or equivalent control period.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available following publication of the main study results and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers upon reasonable request to the corresponding author. Requests should include a brief description of the proposed analysis and intended use of the data. Data will be shared following approval by the study investigators and, where applicable, completion of an appropriate data-sharing agreement.

Locations

SL (1)