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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Primorska

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 to 40 years

Healthy volunteer

Willing and able to provide written informed consent

Disqualifiers

Current or previous lower-limb injury

Neuromuscular disorder

Neurological disorder

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

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

    Procedure/Surgery

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Higher-Cost IASTMExperimental treatment 1 intervention
Group B: Lower-Cost IASTMActive comparator 1 intervention
Group C: Passive ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and immediately after the 6-minute intervention or rest period
2

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.

Time frame
Baseline and immediately after the 6-minute intervention or rest period
3

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.

Time frame
Baseline and immediately after the 6-minute intervention or rest period
4

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.

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

Secondary outcomes

1

Perceived Pleasantness of IASTM

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.

Time frame
Immediately after the 6-minute IASTM intervention
2

Perceived Relaxation After IASTM

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.

Time frame
Immediately after the 6-minute IASTM intervention

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of Primorska, Faculty of Health Sciences, Izola Status unavailable 6310, Izola, Urban Municipality of KoperSloveniaSlovenia

Sponsors and contacts

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