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

16 september 2026 bijgewerkt door: Žiga Kozinc, University of Primorska

Acute Effects of Instrument-Assisted Soft Tissue Mobilization Using Lower-Cost and Higher-Cost Tools Lower-Leg Tissue Stiffness and Ankle Dorsiflexion Range of Motion in Healthy Adults: A Randomized Controlled Trial

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Healthy adults aged 18 to 30 years will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive control. Only one lower limb will be assessed in each participant; the contralateral limb will not serve as a control.

Before and immediately after the intervention or control period, tissue stiffness will be assessed using MyotonPRO (Myoton AS, Tallinn, Estonia) at four predefined locations: the medial gastrocnemius, lateral gastrocnemius, soleus, and Achilles tendon. Gastrocnemius measurement locations will be identified at one-third of the respective anatomical reference distances described in the protocol. The soleus measurement will be performed medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. The Achilles tendon will be assessed 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained at each site at each assessment, and their mean will be used for analysis.

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

Participants in either IASTM group will receive a six-minute standardized treatment of the posterior lower-leg region. The first minute will consist of familiarization with the instrument, desensitization, and application of IASTM cream. This will be followed by five minutes of treatment using long gliding strokes along the direction of the muscle fibers, with the instrument held at approximately a 45-degree angle. Treatment intensity will be adjusted to produce slight pain or moderate discomfort. The treatment protocol will be identical between IASTM groups except for the tool used.

Participants allocated to the control group will rest passively for an equivalent six-minute period without receiving IASTM. Participants receiving IASTM will rate intervention pleasantness and perceived relaxation immediately after treatment using 0-to-10 numerical rating scales.

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Slovenië
    • Urban Municipality of Koper
      • Izola, Urban Municipality of Koper, Slovenië, 6310
        • University of Primorska, Faculty of Health Sciences, Izola
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Higher-Cost IASTM
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
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.
Actieve vergelijker: Lower-Cost IASTM
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
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.
Geen tussenkomst: Passive Control
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Medial Gastrocnemius Stiffness
Tijdsspanne: Baseline and immediately after the 6-minute intervention or rest period
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
Tijdsspanne: Baseline and immediately after the 6-minute intervention or rest period
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
Tijdsspanne: Baseline and immediately after the 6-minute intervention or rest period
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
Tijdsspanne: Baseline and immediately after the 6-minute intervention or rest period
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
Tijdsspanne: Baseline and immediately after the 6-minute intervention or rest period
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perceived Pleasantness of IASTM
Tijdsspanne: Immediately after the 6-minute IASTM intervention
Participants receiving IASTM will rate the pleasantness of the intervention on an 11-point numerical rating scale ranging from 0 to 10, with 0 representing the lowest possible pleasantness and 10 representing the highest possible pleasantness.
Immediately after the 6-minute IASTM intervention
Perceived Relaxation After IASTM
Tijdsspanne: Immediately after the 6-minute IASTM intervention
Participants receiving IASTM will rate their perceived relaxation after the intervention on an 11-point numerical rating scale ranging from 0 to 10, with 0 representing the lowest possible relaxation and 10 representing the highest possible relaxation.
Immediately after the 6-minute IASTM intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Primorska

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

15 december 2026

Studie voltooiing (Geschat)

15 januari 2027

Studieregistratiedata

Eerst ingediend

10 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • UPFVZ-IASTM-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request. After publication of scientific manuscript, the data will also be uploaded to a trusted repository (Zenodo.org).

IPD-tijdsbestek voor delen

Data will become available following publication of the main study results and will remain available for at least 5 years.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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