Instrument-assisted Soft Tissue MobilizationNCT05502497
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Fascia and Fat Tissue Thickness in Healthy Individuals.
A study testing Observational and IASTM Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Fascia
- What is being tested?
- Observational and IASTM Technique Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University
Malatya, 44280
Muhammed Üsame TAŞ, Lecturer, +90 0534 681 25 85 ext. 4848, fzt.muhammedusame.tas@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Fascia, Rehabilitation, Strength, Balance
- Being tested
- Observational, IASTM Technique Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No application will be made to the control group.
IASTM Technique ApplicationOther
Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: IASTM Technique Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Muscle Strength Assessment
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
Measured: Pre-treatment assessment.
Leg Muscle Strength Assessment
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
Measured: 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.
Measured: 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.
Measured: Pre-treatment assessment.
Flexibility Assessment
The sit-and-reach Test will be used to assess the flexibility of individuals.
Measured: 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.
Measured: 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.
Measured: Pre-treatment assessment.
Balance Assessment
Stork Balance Test will be used to evaluate the balance of individuals.
Measured: 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.
Measured: 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.
Measured: Pre-treatment assessment.
Fascia and Adipose Tissue Thickness Assessment
Ultrasound device will be used to measure the thickness of individuals' fascia and adipose tissue.
Measured: 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.
Measured: Control evaluation 1 hour after the end of treatment (third evaluation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Apr 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrument-assisted Soft Tissue MobilizationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Usame TAS, Inonu University
- Investigators
- Muhammed Üsame TAŞ, Lecturer, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502497
- Sponsor's protocol ID
- ÜSAME TAŞ-002
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Strength, Flexibility, Balance and Fascia and Fat Tissue Thickness in Healthy Individuals.
- ClinicalTrials.gov ID
- NCT05502497
- Acronym / sponsor ID
- ÜSAME TAŞ-002
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Fascia, Rehabilitation, Strength, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: ObservationalWhich 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. |
| IASTM Treatment Group | Experimental | Other: IASTM Technique ApplicationWhich 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo application will be made to the control group. | Other | Control Group |
| IASTM Technique ApplicationInstrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes. | Other | IASTM Treatment Group |
Primary outcome
Leg Muscle Strength Assessment
Time frame: Pre-treatment assessment.
The Vertical Jump Test will be used to evaluate the leg muscle strength of individuals.
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.
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.
Flexibility Assessment
Time frame: Pre-treatment assessment.
The sit-and-reach Test will be used to assess the flexibility of individuals.
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.
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.
Balance Assessment
Time frame: Pre-treatment assessment.
Stork Balance Test will be used to evaluate the balance of individuals.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Üsame TAŞ, Lecturer principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observational and IASTM Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Üsame TAŞ, Lecturer (+90 0534 681 25 85 ext. 4848, fzt.muhammedusame.tas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Muscle Strength Assessment (time frame: Pre-treatment assessment.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.