NCT05502497

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 13, 2022

Last Update Submit

August 13, 2022

Conditions

Outcome Measures

Primary Outcomes (12)

  • Leg Muscle Strength Assessment

    The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.

    Pre-treatment assessment.

  • Leg Muscle Strength Assessment

    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

    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

    The sit-and-reach Test will be used to assess the flexibility of individuals.

    Pre-treatment assessment.

  • Flexibility Assessment

    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

    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

    Stork Balance Test will be used to evaluate the balance of individuals.

    Pre-treatment assessment.

  • Balance Assessment

    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

    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

    Ultrasound device will be used to measure the thickness of individuals' fascia and adipose tissue.

    Pre-treatment assessment.

  • Fascia and Adipose Tissue Thickness Assessment

    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

    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).

Study Arms (2)

Control Group

OTHER

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

IASTM Treatment Group

EXPERIMENTAL

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

Interventions

No application will be made to the control group.

Control Group

Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.

IASTM Treatment Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Muhammed Üsame TAŞ, Lecturer

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Üsame TAŞ, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 16, 2022

Study Start

April 1, 2021

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations