[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656230":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":58,"overallOfficials":32,"centralContacts":68,"locations":75,"responsibleParty":87,"collaborators":32,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":32,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":32,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":121,"whyStopped":32,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Primorska","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":32},[9,13,15,18,21],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Medial Gastrocnemius Stiffness","Tissue stiffness will be measured using MyotonPRO and expressed in N\u002Fm. Two consecutive measurements will be obtained at each assessment and averaged.","Baseline and immediately after the 6-minute intervention or rest period",{"measure":14,"description":11,"timeFrame":12},"Change From Baseline in Lateral Gastrocnemius Stiffness",{"measure":16,"description":17,"timeFrame":12},"Change From Baseline in Soleus Stiffness","Tissue stiffness will be measured using MyotonPRO and expressed in N\u002Fm. 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.",{"measure":19,"description":20,"timeFrame":12},"Change From Baseline in Achilles Tendon Stiffness","Achilles tendon stiffness will be measured using MyotonPRO and expressed in N\u002Fm at a predefined site 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained and averaged.",{"measure":22,"description":23,"timeFrame":12},"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.",[25,29],{"measure":26,"description":27,"timeFrame":28},"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.","Immediately after the 6-minute IASTM intervention",{"measure":30,"description":31,"timeFrame":28},"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.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","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.","BASIC_SCIENCE",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","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.\n\nBefore 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.\n\nAnkle 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.\n\nParticipants 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.\n\nParticipants 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.",[42,48,54],{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47],"Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool",{"label":55,"type":56,"description":57,"interventionNames":32},"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.",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":32},"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.",[43],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":32},"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.",[49],[69],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Žiga Kozinc, PhD","CONTACT","040161503","+386","ziga.kozinc@s2p.si",[76],{"facility":77,"status":32,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":32,"geoPoint":32,"contacts":83},"University of Primorska, Faculty of Health Sciences, Izola","Izola","Urban Municipality of Koper","6310","Slovenia","SI",[84],{"name":85,"role":71,"phone":72,"phoneExt":32,"email":86},"Ziga Kozinc, PhD","ziga.kozinc@fvz.upr.si",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Žiga Kozinc","Assoc. prof. dr.","100656230","immediate-effects-of-two-iastm-tools-on-lower-leg-tissue-stiffness-and-ankle-mobility-100656230",false,"NCT07822594","Immediate Effects of Two IASTM Tools on Lower-Leg Tissue Stiffness and Ankle Mobility","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","Inclusion Criteria:\n\n* Age 18 to 40 years\n* Healthy volunteer\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Current or previous lower-limb injury\n* Neuromuscular disorder\n* Neurological disorder",true,"ALL","18 Years","40 Years",{"count":103,"type":104},45,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.\n\nTissue 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.\n\nThe 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.",[110],"Muscle Stiffness",[112,113,114,115,116,117,118,119,120],"instrument-assisted soft tissue mobilization","soft tissue mobilization","muscle stiffness","ankle dorsiflexion","MyotonPRO","gastrocnemius","soleus","Achilles tendon","range of motion","NOT_YET_RECRUITING","2026-09-16",{"date":124,"type":125},"2026-09-17","ACTUAL",{"date":127,"type":104},"2026-10-01",{"date":129,"type":104},"2027-01-15",{"name":5,"class":6},1]