Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Fascia and Fat Tissue Thickness in Healthy Individuals.

August 13, 2022 updated by: Muhammed Usame TAS, Inonu University

Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Strength, Flexibility, Balance and Fascia and Fat Tissue Thickness in Healthy Individuals.

Instrument-assisted soft tissue mobilization (IASTM) technique can be used for non-pathological conditions as it has been shown in previous literature to affect flexibility and normal range of motion. The use of instrument-assisted soft tissue mobilization technique has been claimed to be an effective treatment in increasing tissue temperature, reducing adhesion to connective tissue and increasing collagen adaptation and increasing flexibility and normal range of motion. The instrument-assisted soft tissue mobilization technique works on the facial connective tissue in the body. This connective tissue contains "sheaths of collagen, which form the cavities and muscle divisions that mainly cover the organs." In some studies, they stated that instrument-assisted soft tissue mobilization increased perfusion, while in some studies they stated that instrument-assisted soft tissue mobilization increased blood circulation.

The frequency of ultrasonography (USG) examinations for the musculoskeletal system has increased over time with technological developments and USG has entered daily use in the evaluation of various pathological conditions belonging to this system thanks to its comparable results with MR examinations. The unique advantages of USG such as low cost, easy availability, relatively short examination time, and dynamic real-time comparison with the contralateral side have made it easier to use for musculoskeletal examinations.

The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization technique on strength, flexibility, balance, fascia and adipose tissue thickness in healthy individuals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the study, iASTM will be applied to healthy individuals and the effect of this technique will be examined. Demographic information of individuals will be recorded; Individuals will be evaluated in detail in terms of muscle strength, flexibility, balance, and fascia and adipose tissue thickness.

The work plan; pre-treatment evaluation, followed by treatment, second evaluation immediately after the end of treatment and control evaluation (third evaluation) 1 hour after the end of treatment. The data collection period is planned as 1,5 year.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • 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 Contact

Study Locations

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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Consists of healthy individuals between the ages of 18-35,
  2. No history of orthopedic injury (muscle, tendon, joint capsule, ligament damage or peripheral neuropathy) in the lower extremities in the last 1 year,
  3. Being able to express himself without cognitive, cognitive and mental problems,
  4. Voluntarily agree to participate in the study.

Exclusion Criteria:

  1. Injury to any lower extremity between measurements during the treatment process,
  2. Having a BMI over 25,
  3. Surgery or arthritis in the last 1 year,
  4. Not being able or unwilling to do the tests,
  5. Not wanting to leave of their own accord.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Which leg of the individuals will be treated will be determined by tossing a coin. After the toss, the right leg will be applied when the tail comes, and the left leg will be applied when it comes to the heads. The leg to be treated, the treatment group of the individuals; the other leg (the untreated leg) will form the control group of the individuals.
Other: Observational
No application will be made to the control group.
Experimental: IASTM Treatment Group
Which leg of the individuals will be treated will be determined by tossing a coin. After the toss, the right leg will be applied when the tail comes, and the left leg will be applied when it comes to the heads. The leg to be treated, the treatment group of the individuals; the other leg (the untreated leg) will form the control group of the individuals.
Other: IASTM Technique Application
Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg Muscle Strength Assessment
Time Frame: Pre-treatment assessment.
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
Pre-treatment assessment.
Leg Muscle Strength Assessment
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
Second assessment immediately after the end of the 10-minute treatment.
Leg Muscle Strength Assessment
Time Frame: Control evaluation 1 hour after the end of treatment (third evaluation).
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
Control evaluation 1 hour after the end of treatment (third evaluation).
Flexibility Assessment
Time Frame: Pre-treatment assessment.
The sit-and-reach Test will be used to assess the flexibility of individuals.
Pre-treatment assessment.
Flexibility Assessment
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
The sit-and-reach Test will be used to assess the flexibility of individuals.
Second assessment immediately after the end of the 10-minute treatment.
Flexibility Assessment
Time Frame: Control evaluation 1 hour after the end of treatment (third evaluation).
The sit-and-reach Test will be used to assess the flexibility of individuals.
Control evaluation 1 hour after the end of treatment (third evaluation).
Balance Assessment
Time Frame: Pre-treatment assessment.
Stork Balance Test will be used to evaluate the balance of individuals.
Pre-treatment assessment.
Balance Assessment
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
Stork Balance Test will be used to evaluate the balance of individuals.
Second assessment immediately after the end of the 10-minute treatment.
Balance Assessment
Time Frame: Control evaluation 1 hour after the end of treatment (third evaluation).
Stork Balance Test will be used to evaluate the balance of individuals.
Control evaluation 1 hour after the end of treatment (third evaluation).
Fascia and Adipose Tissue Thickness Assessment
Time Frame: Pre-treatment assessment.
Ultrasound device will be used to measure the thickness of individuals' fascia and adipose tissue.
Pre-treatment assessment.
Fascia and Adipose Tissue Thickness Assessment
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
Ultrasound device will be used to measure the thickness of individuals' fascia and adipose tissue.
Second assessment immediately after the end of the 10-minute treatment.
Fascia and Adipose Tissue Thickness Assessment
Time Frame: Control evaluation 1 hour after the end of treatment (third evaluation).
Ultrasound device will be used to measure the thickness of individuals' fascia and adipose tissue.
Control evaluation 1 hour after the end of treatment (third evaluation).

Collaborators and Investigators

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

Sponsor

Inonu University

Investigators

  • Principal Investigator: Muhammed Üsame TAŞ, Lecturer, Inonu 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)

April 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 13, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ÜSAME TAŞ-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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