NCT06934694

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

April 11, 2025

Last Update Submit

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

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.

Device: Instrument-Assisted Soft Tissue Mobilization

Control

NO INTERVENTION

Interventions

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).

IASTM

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations