Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain

September 11, 2023 updated by: Erkan Erol, Tokat Gaziosmanpasa University
Instrument assisted soft tissue mobilization (IASTM) is one of the methods used to achieve fascial release. In this study, it will be examined whether there will be an increase in hamstring flexibility by releasing the superficial posterior fascial chain as a result of the IASTM technique to be applied over the triceps surae muscle and plantar fascia. Sociodemographic information of individuals who meet the inclusion criteria and volunteer to participate in the study will be obtained, and straight leg lift test and popliteal angle measurement will be performed with the digital inclinometer (Baseline Digital Inclinometer) to be provided within the scope of the project to measure hamstring flexibility. Then, IASTM will be applied to the triceps surae muscle and plantar fascia for 15 minutes. Measurements will be repeated after the application.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60250
        • Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals with a straight leg lift test less than 80° and a popliteal angle greater than 15° will be included in the study.

Exclusion Criteria:

  • Individuals with a history of lower extremity fractures, lumbar disc herniation, acute pain, a history of lesion in the hamstring muscles at least 1 month before the study, knee or hip prosthesis, and those using drugs that may affect the measurements (e.g., muscle relaxants) will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Instrument Assisted Soft Tissue Mobilization Group
With the IASTM device, application will be made over the skin to the triceps surae muscle and plantar fascia for 15 minutes. The application will be made in the prone position. Massage oil will be used to reduce tissue friction before the application.
Other: Instrument Assisted Soft Tissue Mobilization
With the IASTM device, application will be made over the skin to the triceps surae muscle and plantar fascia for 15 minutes. The application will be made in the prone position. Massage oil will be used to reduce tissue friction before the application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Straight Leg Raise Test
Time Frame: Baseline
Measurements will be made with a digital inclinometer. In the supine position, the digital inclinometer will be inserted into the tuberositas tibia. Then, the participant's leg will be passively lifted by the researcher with the knee extended. The leg will be brought to the point where the tension is felt, where the value on the inclinometer will be recorded. It will then return to the starting position. The procedure will be repeated for both legs.
Baseline
Straight Leg Raise Test
Time Frame: 1 hour
Measurements will be made with a digital inclinometer. In the supine position, the digital inclinometer will be inserted into the tuberositas tibia. Then, the participant's leg will be passively lifted by the researcher with the knee extended. The leg will be brought to the point where the tension is felt, where the value on the inclinometer will be recorded. It will then return to the starting position. The procedure will be repeated for both legs.
1 hour
Popliteal angle test
Time Frame: Baseline
In the supine position, the hip and knee will be brought to 90 degrees. The digital inclinometer will be placed on the tuberositas tibia and the participant will be asked to extend the knee while maintaining the position of the hip. At the last point, the value on the inclinometer will be recorded. It will then return to the starting position. The procedure will be repeated for both legs.
Baseline
Popliteal angle test
Time Frame: 1 hour
In the supine position, the hip and knee will be brought to 90 degrees. The digital inclinometer will be placed on the tuberositas tibia and the participant will be asked to extend the knee while maintaining the position of the hip. At the last point, the value on the inclinometer will be recorded. It will then return to the starting position. The procedure will be repeated for both legs.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GaziosmanpasaU_Erol_06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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