Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Effects of Different Instrument Assisted Soft Tissue Mobilization Force Applications on Ankle Stiffness and Dorsiflexion

4 de novembro de 2026 atualizado por: Nickolai Martonick, University of Idaho

Effects of Different IASTM Force Applications on Ankle Stiffness and Dorsiflexion

Instrument-assisted soft tissue mobilization (IASTM) is a technique commonly used in sports medicine to reduce muscle tightness and improve range of motion. The technique involves using a handheld instrument, typically made of metal, to apply pressure and massage soft tissues. The instrument allows clinicians to target specific areas while reducing stress on their hands. Previous research has demonstrated that IASTM may improve range of motion and reduce muscle tightness. However, little is known about how the amount of force applied during treatment influences these outcomes. This study aims to investigate the effects of different IASTM treatment forces on calf muscle stiffness and ankle dorsiflexion (the movement of the foot upward toward the shin). Participants will receive either low-force IASTM (0-5 N), high-force IASTM (10-15 N), or no treatment depending on what group they are assigned to. Treatment force will be monitored using a sensor attached to the IASTM instrument (Figure 1). Changes in tissue stiffness will be assessed using the MyotonPRO, a handheld device that measures the mechanical properties of muscles and other soft tissues. Changes in ankle dorsiflexion will be evaluated using clinical movement tests and motion capture analysis.

The findings may help researchers and clinicians better understand how different IASTM treatment protocols influence tissue stiffness and ankle mobility, potentially contributing to more standardized treatment recommendations.

Visão geral do estudo

Descrição detalhada

Participants will complete a single laboratory visit lasting approximately 82 minutes.

  1. Informed Consent and Demographics (~7 minutes) Upon arrival, a member of the research team will verbally review the study procedures, expectations, and potential risks. Risks include temporary discomfort during treatment, red marks on the skin, and mild soreness the following day. Participants will have the opportunity to ask questions before signing the informed consent document. After signing, participants will have the opportunity to change into athletic shorts in a nearby locker room. The research team will then record each participant's height, mass, and age, with height and mass measured without shoes. Participants will remain barefoot for all tasks.

  2. Familiarization With Movement Tasks (~5 minutes) Participants will practice each movement task before data collection.

    Weight Bearing Lunge Test (WBLT). The participant stands with one foot behind the other. They hold a dowel for balance in the hand opposite the back foot. The back leg is extended to a straight knee position, with the heel pressed into the floor and the second toe pointed forward. The participant adjusts foot position until they feel a stretch in the calf while keeping the heel on the ground. They then drive the hips forward, bending the front knee until the heel lifts from the ground. The distance between the front and back foot is adjusted as needed to maintain these parameters.

    Gait. Participants will walk back and forth across a pressure sensing walkway until they are comfortable with their walking pattern in the laboratory. They will walk at two speeds. The slow pace is as if they have somewhere to be but are not in a hurry. The fast pace is as if they are walking for exercise.

    Overhead Deep Squat (OHDS). The participant stands with feet shoulder width apart and toes pointed forward. They hold a plastic dowel overhead with both hands and arms extended. The participant squats as deep as possible and returns to standing in one continuous motion.

    Functional Movement Screen (FMS) Ankle Clearing Test. The participant stands with the feet positioned heel to toe and uses a dowel for balance. Keeping the rear heel in contact with the floor, the participant flexes the rear knee forward as far as possible until the heel lifts from the ground.

  3. Restricted Ankle Dorsiflexion Assessment (~3 minutes) Participants will repeat the FMS Ankle Clearing Test to determine eligibility for the treatment portion of the study. Both ankles will be assessed. A member of the research team will hold a plumb line at the patella to judge knee position. If the knee does not advance past the medial malleolus of the front foot before the rear heel lifts, the ankle will be classified as having a dorsiflexion restriction.

    Participants who report pain during the ankle screening will be excluded from further participation and referred for appropriate evaluation.

    Participants with bilateral dorsiflexion restrictions will be eligible for the IASTM portion of the study, which tests whether IASTM improves limited weight bearing dorsiflexion. These participants will be randomly assigned to a high force IASTM, low force IASTM, or no treatment control group.

    Participants without bilateral restrictions will complete baseline testing only. Including these participants captures a wide range of dorsiflexion capacity. This allows the study to examine relationships among ankle stiffness, ankle mobility, and functional movement.

  4. Myotonometry Preparation and Measurement Site Identification (~15 minutes) Participants will lie prone on an examination table. A 4 inch diameter foam roller will be placed beneath the anterior ankles and feet to maintain slight knee flexion and a relaxed lower limb. Participants will hold this position for site identification and for all MyotonPRO measurements.

    Measurement sites will be identified bilaterally using anatomical landmarks and a flexible measuring tape, following the multipoint mapping protocol described by Duarte et al. (2026).

    Posterior lower leg. The distance from the center of the popliteal fossa to the calcaneal tuberosity will be divided into eight equal intervals, which creates seven equidistant reference points.

    At the three most proximal points, additional marks will be placed 2 cm medial and 2 cm lateral. These mark the measurement sites for the medial and lateral gastrocnemius.

    The next point distal identifies the musculotendinous junction of the gastrocnemius and Achilles tendon.

    The three most distal points identify the Achilles tendon measurement sites.

    Plantar fascia. The distance from the calcaneal tuberosity to the base of the second and third toes will be divided into four equal intervals, which creates three equidistant measurement sites.

    All sites will be marked on the skin with a skin safe marker to ensure consistent probe placement throughout the session.

  5. Baseline Myotonometry (~3 minutes) Baseline tissue stiffness will be measured bilaterally at each marked site with the MyotonPRO. Measurements will proceed proximal to distal and medial to lateral, starting with the right leg and then the left. The probe will be held perpendicular to the skin according to the manufacturer's procedures. The probe delivers a brief mechanical impulse to the skin and uses the resulting oscillation to calculate tissue stiffness parameters. Each measurement takes less than one second.

  6. Inertial Measurement Unit (IMU) Placement (~5 minutes) Nine IMU sensors will be secured with elastic tape or bands so they remain in place during movement. The sites are the dorsum of each foot, each shin, each thigh, and the low, middle, and upper back.

  7. Baseline Movement Analysis (~12 minutes)

    Participants will perform the following tasks in order:

    Slow walking: 10 passes on the 3 meter walkway Fast walking: 10 passes on the 3 meter walkway OHDS: 8 repetitions FMS Ankle Clearing Test: 3 repetitions WBLT: 3 repetitions

    All tasks will follow the procedures described during familiarization. Before each task, participants will perform brief calibration trials of approximately 10 seconds, standing still or walking a few strides. After the OHDS, FMS Ankle Clearing Test, and WBLT, participants will rate calf tightness on a 0 to 10 visual analog scale (VAS). On this scale, 0 represents no tightness and 10 represents extreme tightness.

  8. Pretreatment Myotonometry (~3 minutes) MyotonPRO measurements will be repeated bilaterally at each site following the baseline movement analysis.

  9. IASTM Treatment or Control (~12 minutes) Participants with bilateral dorsiflexion restrictions will receive the condition to which they were randomized. The control group will lie prone on the treatment table for 12 minutes without treatment.

    All IASTM treatments will be administered by Aletha Lassiter. Water based ultrasound gel will be applied to the treatment area to reduce friction between the instrument and the skin.

    High force group: 10 to 15 N at 60 strokes per minute Low force group: 0 to 5 N at 90 strokes per minute

    A metronome will guide stroke rate in both groups. A force sensor attached to the IASTM instrument will monitor applied force so it remains within the prescribed range. Both force ranges fall within those reported for trained clinicians using IASTM.

    Pressure tolerance screening. Before treatment, a few strokes at the participant's assigned force will be applied longitudinally along the gastrocnemius and soleus, parallel to the muscle fibers. Participants will rate their discomfort on a 0 to 10 VAS, where 0 represents no discomfort and 10 represents intolerable discomfort. Participants who rate discomfort above 8 will be excluded from further participation.

    Treatment. Participants who pass the tolerance screening will receive 3 minutes of IASTM per leg, for 6 minutes total. Sweeping strokes will be applied longitudinally along the gastrocnemius muscle belly and soleus, parallel to the muscle fibers. Both legs will receive the assigned condition. The research team will monitor participants for intolerable discomfort throughout treatment.

    After treatment, participants will complete a brief questionnaire on their perception of the intervention. They will also provide a separate 0 to 10 VAS discomfort rating for the full treatment of each leg. Excess gel will then be removed from the instrument, and the instrument will be sanitized with an alcohol wipe before the next use.

  10. Post-treatment Myotonometry (~3 minutes) MyotonPRO measurements will be repeated bilaterally at each site immediately after the IASTM or control condition.

  11. Post-treatment Movement Analysis (~12 minutes) Participants will repeat all movement tasks in the same order, with the same number of repetitions, calibration trials, and calf tightness ratings as the baseline analysis.

  12. Follow-up Questionnaire (~2 minutes) After the final movement analysis, participants will complete a brief questionnaire about their experience with IASTM in the laboratory.

Tipo de estudo

Intervencional

Inscrição (Estimado)

45

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Idaho
      • Moscow, Idaho, Estados Unidos, 83843
        • Integrated Sports Medicine and Movement Analysis Laboratory
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 39 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

- You are between 18 and 39 years of age You are able to stand, walk, squat, and lunge barefoot without assistance You are able to read and understand English and provide written informed consent

Exclusion Criteria:

- You do not have a current skin infection. You do not have any prior lower extremity surgeries for muscles, bones, or joints.

You do not have a current injury that limits your gait or ability to squat. You are not currently pregnant. You are not taking any anticoagulant medications, or medications that would inhibit your balance, or pain perception.

You do not have an allergy to ultrasound gel.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: High force of IASTM treatment

A single session of instrument assisted soft tissue mobilization applied to the gastrocnemius and soleus of both legs. Strokes are applied longitudinally, parallel to the muscle fibers, at 10 to 15 N and 60 strokes per minute. A metronome paces the stroke rate, and a force sensor attached to the instrument confirms the applied force. Each leg receives 3 minutes of treatment, for 6 minutes total, with water based ultrasound gel as a lubricant.

A single session of instrument assisted soft tissue mobilization applied bilaterally to the gastrocnemius and soleus muscle bellies. One trained clinician delivers all treatments using the convex edge of the RockBlades 2.0 Mallet (RockTape, Durham, NC), a solid surgical stainless steel instrument fitted with a force sensor. Real time force feedback keeps applied force within the assigned range, and a metronome paces stroke rate. Sweeping strokes are applied longitudinally, parallel to the muscle fibers, with water based ultrasound gel as the lubricant, for 3 minutes per leg (6 minutes total). A pretreatment tolerance screening excludes participants who rate discomfort above 8 on a 0 to 10 VAS. No stretching, warm up, exercise, or other manual therapy accompanies treatment. The protocol is distinguished from other IASTM interventions by quantified, controlled force, a fixed stroke rate, and a single session dose.

Experimental: Low force IASTM treatment

A single session of instrument assisted soft tissue mobilization applied to the gastrocnemius and soleus of both legs. Strokes are applied longitudinally, parallel to the muscle fibers, at 0 to 5 N and 90 strokes per minute. A metronome paces the stroke rate, and a force sensor attached to the instrument confirms the applied force. Each leg receives 3 minutes of treatment, for 6 minutes total, with water based ultrasound gel as a lubricant.

A single session of instrument assisted soft tissue mobilization applied bilaterally to the gastrocnemius and soleus muscle bellies. One trained clinician delivers all treatments using the convex edge of the RockBlades 2.0 Mallet (RockTape, Durham, NC), a solid surgical stainless steel instrument fitted with a force sensor. Real time force feedback keeps applied force within the assigned range, and a metronome paces stroke rate. Sweeping strokes are applied longitudinally, parallel to the muscle fibers, with water based ultrasound gel as the lubricant, for 3 minutes per leg (6 minutes total). A pretreatment tolerance screening excludes participants who rate discomfort above 8 on a 0 to 10 VAS. No stretching, warm up, exercise, or other manual therapy accompanies treatment. The protocol is distinguished from other IASTM interventions by quantified, controlled force, a fixed stroke rate, and a single session dose.

Sem intervenção: Control group

Participants lie prone on the treatment table for 12 minutes without treatment. This matches the duration of the IASTM session.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Weight Bearing Ankle Dorsiflexion Range of Motion
Prazo: Baseline and immediately after the intervention or control condition (within 30 minutes, same session)

Ankle dorsiflexion is the ability to bend the ankle so the shin moves forward over the foot. It is measured with the Weight Bearing Lunge Test. The participant stands in a split stance, keeps the back heel on the floor, and bends the front knee forward as far as possible until the front heel begins to lift. An inertial measurement unit (a small motion sensor) on the shin records the angle of the shin relative to vertical at the moment the heel lifts. [Confirm this is how the angle is derived.] Each leg is tested 3 times, and the mean of the 3 trials is used. Values are reported in degrees, and higher values indicate greater ankle mobility. Change is calculated as the post-treatment value minus the baseline value

Baseline and immediately after the intervention or control condition (within 30 minutes, same session)
Change in Dynamic Stiffness of the Calf Muscles, Achilles Tendon, and Plantar Fascia
Prazo: Baseline and immediately after the intervention or control condition (within 30 minutes, same session)

Tissue stiffness is measured with the MyotonPRO (Myoton AS, Tallinn, Estonia). This handheld device applies a brief, painless mechanical tap to the skin and records how the underlying tissue oscillates in response. Participants lie face down on an examination table with a foam roller under the front of the ankles to keep the knees slightly bent and the legs relaxed. The probe is held perpendicular to the skin.

Baseline and immediately after the intervention or control condition (within 30 minutes, same session)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Nick JP Martonick, PhD ATC, University of Idaho

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

4 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 26-259

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Deidentified individual participant data will be shared for all enrolled participants. The dataset includes:

Participant age, sex, height, and mass; Ankle dorsiflexion restriction status and group assignment (high force IASTM, low force IASTM, control, or baseline only); Weight bearing ankle dorsiflexion angles from the Weight Bearing Lunge Test for each leg and trial; MyotonPRO dynamic stiffness values for each measurement site and leg; Joint angles from the Overhead Deep Squat; Walking speed and gait variables at slow and fast speeds; Calf tightness and treatment discomfort ratings;

Data are provided for each available time point (baseline, pretreatment, and post-treatment), along with a data dictionary that defines each variable and its units. Names, dates of birth, contact information, and testing dates will be removed before sharing.

Prazo de Compartilhamento de IPD

Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.

Critérios de acesso de compartilhamento IPD

Deidentified individual participant data, a data dictionary, the study protocol, the statistical analysis plan, and analytic code will be publicly available to any researcher, without restriction, through osf.io

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever