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临床试验/NCT07822594
NCT07822594尚未招募不适用

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

University of Primorska1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Change From Baseline in Medial Gastrocnemius Stiffness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 30 years
  • Healthy volunteer
  • Willing and able to provide written informed consent

排除标准

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

研究组 & 干预措施

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.

干预措施: Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool (Procedure)

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.

干预措施: Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool (Procedure)

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.

结局指标

主要结局

Change From Baseline in Medial Gastrocnemius Stiffness

时间窗: 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.

Change From Baseline in Lateral Gastrocnemius Stiffness

时间窗: 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.

Change From Baseline in Soleus Stiffness

时间窗: 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.

Change From Baseline in Achilles Tendon Stiffness

时间窗: 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.

Change From Baseline in Ankle Dorsiflexion Range of Motion

时间窗: 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.

次要结局

  • Perceived Pleasantness of IASTM(Immediately after the 6-minute IASTM intervention)
  • Perceived Relaxation After IASTM(Immediately after the 6-minute IASTM intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Žiga Kozinc

Assoc. prof. dr.

University of Primorska

研究点 (1)

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