HealthyNCT05750550
Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain
A study testing Instrument Assisted Soft Tissue Mobilization in people with Healthy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 30 Jun 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals with a straight leg lift test less than 80° and a popliteal angle greater than 15° will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province, 60250
About this study
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.
- Conditions
- Healthy
- Being tested
- Instrument Assisted Soft Tissue Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization Group | Experimental | 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. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straight Leg Raise Test
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.
Measured: Baseline
Straight Leg Raise Test
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.
Measured: 1 hour
Popliteal angle test
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.
Measured: Baseline
Popliteal angle test
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start30 Mar 2023
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Erol, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750550
- Sponsor's protocol ID
- GaziosmanpasaU_Erol_06
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erol E, Bulut BN. Acute effect of instrument-assisted soft tissue mobilization on hamstring flexibility via fascial chain. BMC Musculoskelet Disord. 2024 Dec 19;25(1):1046. doi: 10.1186/s12891-024-08182-7.
PubMed 39702162
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain
- ClinicalTrials.gov ID
- NCT05750550
- Acronym / sponsor ID
- GaziosmanpasaU_Erol_06
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Mar 2023 (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) 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization Group | Experimental | Other: Instrument Assisted Soft Tissue MobilizationWith 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals with a straight leg lift test less than 80° and a popliteal angle greater than 15° will be included in the study.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationWith 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 Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39702162Erol E, Bulut BN. Acute effect of instrument-assisted soft tissue mobilization on hamstring flexibility via fascial chain. BMC Musculoskelet Disord. 2024 Dec 19;25(1):1046. doi: 10.1186/s12891-024-08182-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization in people with Healthy, run by Tokat Gaziosmanpasa 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Straight Leg Raise Test (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750550, which also lists 1 linked publication.
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 13 Sep 2023.