Healthy(IASTM)NCT06610058
Effects of Instrument Assisted Soft Tissue Mobilization Regarding Range of Motion and Lower Extremity Power
A study of Healthy, run by Beth Marschner at 1 site in United States.
Trial summary
The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy adult volunteers. The main questions it aims to answer are: Does IASTM treatment have an effect on range of motion (ROM) as measured in the hip, knee and ankle? Does IASTM treatment have an effect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 29 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals from a small regional university student body, faculty and staff may choose to volunteer to participate in this study.
Who cannot join
- Acute spinal cord injury with neurological deficits
- Neurological disorders
- Acute lower extremity injury such as sprain or strain
- Acute lower extremity pain causing gait deviation
- Any type of lower extremity fracture within the past 12 months
- Lumbar disc pathology with radicular symptoms
- Use of blood thinning or clotting medications
- Known connective tissue disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Lower Extremity Power
The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy adult volunteers. The main questions it aims to answer are:
- Does IASTM treatment have an effect on range of motion (ROM) as measured in the hip, knee and ankle?
- Does IASTM treatment have an effect on lower extremity power? Researchers will compare pre-test and post-test IASTM treatment intervention data to the pre-test and post-test data of the no treatment control intervention to see if IASTM works to change range of motion and/or lower extremity power.
Read more
Participants will:
- Complete a questionnaire on medical history and injury background
- Have hip, knee and ankle range of motion (ROM) measurements taken on both lower extremities using a goniometer
- Complete three trials of vertical jump testing using a Fleage Floor standing vertical jump measurement tester with one warm up first
- Complete three trials of horizontal jump testing using a Woanger 12'x2.5' long jump mat and verified by a secondary measure using a tape measure with one warm up first
- Be randomly assigned to either IASTM first treatment group or the wait/control first group
- Receive IASTM treatment techniques including application of emollient to the skin to reduce friction on the surface followed by scanning the hamstrings, quadriceps, gastroc/soleus complex, and Achilles tendon using the HG8-Scanner tool for 15 strokes in each direction. Then the concave tool corresponding to the size of the structure being treated will be used (HG6-Large Multi-Curve, HG5-Medium Multi-Curve, HG4-Small Multi-Curve) for 15 strokes in each direction.
- Simply wait for 20 minutes (the duration of time treatment with IASTM would require) when completing the control treatment.
- Complete hip, knee and ankle range of motion and vertical and horizontal jump measure testing at the end of the first session.
- Return within fourteen days after the first session in order to undergo the opposite experience (IASTM first means wait/control second and vice versa).
- Undergo the same baseline pre-test measurements for range of motion and vertical and horizontal jump measure testing as the first session.
- Experience the opposite treatment for the same time period as the first session.
- Undergo the post-test range of motion and vertical and horizontal jump measure testing at the end of the second session for data comparison.
Read the detailed description
No further information to note than what is described in the summary or elsewhere
- Conditions
- Healthy
- Being tested
- Instrument Assisted Soft Tissue Mobilization first Control second, Control first Instrument Assisted Soft Tissue Mobilization second
- Keywords
- Instrument Assisted Soft Tissue Mobilization, Range of Motion, Lower Extremity Power, Vertical Jump, Horizontal Jump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue Mobilization first Control secondOther
Instrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day.
Control first Instrument Assisted Soft Tissue Mobilization secondOther
This intervention involved waiting for 20 minutes between pre-test and post-test on day one and having Instrument Assisted Soft Tissue Mobilization on day two.
| Study group | Role | What they receive |
|---|---|---|
| IASTM First | Experimental | This arm of the study received IASTM treatment on the first day and the wait/control on the second day of the study Receives: Other: Instrument Assisted Soft Tissue Mobilization first Control second |
| Wait/control First | Experimental | This arm of the study waited (was the control) on the first day and received IASTM treatment on the second day of the study. Receives: Other: Control first Instrument Assisted Soft Tissue Mobilization second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Bilateral hip flexion, extension and abduction, knee flexion and extension, ankle plantarflexion, dorsiflexion, inversion and eversion range of motion measurements were taken in supine or prone (whichever was appropriate) using a goniometer.
Measured: From baseline to end of session at one hour
Lower Extremity Power Horizontal Jump
Lower extremity power was measured by completing three trials of horizontal jump testing using a Woanger 12'x2.5' long jump mat with the distance verified by a secondary measure using a tape measure with one warm up first and 90 seconds to recover between each jump.
Measured: From baseline to end of session at one hour
Lower Extremity Power Vertical Jump
Lower extremity power was measured by completing three trials of vertical jump testing using a Fleage Floor standing vertical jump measurement tester with one warm up first and 90 seconds to recover between each jump.
Measured: From baseline to end of session at one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start8 Jan 2024
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Marschner
- Sponsor type
- University, hospital or other
- Collaborators
- Minot State University
- Responsible party
- Sponsor-investigator, Beth Marschner, Minot State University
- Investigators
- Beth Marschner, DPT, Principal investigator, Minot State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610058
- Sponsor's protocol ID
- 2428
- Acronym
- (IASTM)
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data is not the main focus of this study. The overall findings of the study with the larger number of participants to look at the trend is what will be shared (presented or published). The IRB proposal for this study included confidentiality of each individual participant as that will be maintained, but the global findings are what will be shared after data analysis for comparison.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Lower Extremity Power
- ClinicalTrials.gov ID
- NCT06610058
- Acronym / sponsor ID
- (IASTM) / 2428
- Conditions
- Healthy
- Keywords
- Instrument Assisted Soft Tissue Mobilization, Range of Motion, Lower Extremity Power, Vertical Jump, Horizontal Jump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth MarschnerUniversity, hospital or other
- Collaborators
- Minot State University
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 24 Sep 2024 (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.
The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy adult volunteers. The main questions it aims to answer are:
- Does IASTM treatment have an effect on range of motion (ROM) as measured in the hip, knee and ankle?
- Does IASTM treatment have an effect on lower extremity power? Researchers will compare pre-test and post-test IASTM treatment intervention data to the pre-test and post-test data of the no treatment control intervention to see if IASTM works to change range of motion and/or lower extremity power.
Participants will:
- Complete a questionnaire on medical history and injury background
- Have hip, knee and ankle range of motion (ROM) measurements taken on both lower extremities using a goniometer
- Complete three trials of vertical jump testing using a Fleage Floor standing vertical jump measurement tester with one warm up first
- Complete three trials of horizontal jump testing using a Woanger 12'x2.5' long jump mat and verified by a secondary measure using a tape measure with one warm up first
- Be randomly assigned to either IASTM first treatment group or the wait/control first group
- Receive IASTM treatment techniques including application of emollient to the skin to reduce friction on the surface followed by scanning the hamstrings, quadriceps, gastroc/soleus complex, and Achilles tendon using the HG8-Scanner tool for 15 strokes in each direction. Then the concave tool corresponding to the size of the structure being treated will be used (HG6-Large Multi-Curve, HG5-Medium Multi-Curve, HG4-Small Multi-Curve) for 15 strokes in each direction.
- Simply wait for 20 minutes (the duration of time treatment with IASTM would require) when completing the control treatment.
- Complete hip, knee and ankle range of motion and vertical and horizontal jump measure testing at the end of the first session.
- Return within fourteen days after the first session in order to undergo the opposite experience (IASTM first means wait/control second and vice versa).
- Undergo the same baseline pre-test measurements for range of motion and vertical and horizontal jump measure testing as the first session.
- Experience the opposite treatment for the same time period as the first session.
- Undergo the post-test range of motion and vertical and horizontal jump measure testing at the end of the second session for data comparison.
Detailed description
No further information to note than what is described in the summary or elsewhere
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM First | Experimental | Other: Instrument Assisted Soft Tissue Mobilization first Control secondThis arm of the study received IASTM treatment on the first day and the wait/control on the second day of the study |
| Wait/control First | Experimental | Other: Control first Instrument Assisted Soft Tissue Mobilization secondThis arm of the study waited (was the control) on the first day and received IASTM treatment on the second day of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals from a small regional university student body, faculty and staff may choose to volunteer to participate in this study.
Key exclusion criteria (8 listed)
- Acute spinal cord injury with neurological deficits
- Neurological disorders
- Acute lower extremity injury such as sprain or strain
- Acute lower extremity pain causing gait deviation
- Any type of lower extremity fracture within the past 12 months
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 Mobilization first Control secondInstrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day. | Other | IASTM First |
| Control first Instrument Assisted Soft Tissue Mobilization secondThis intervention involved waiting for 20 minutes between pre-test and post-test on day one and having Instrument Assisted Soft Tissue Mobilization on day two. | Other | Wait/control First |
Primary outcome
Range of Motion
Time frame: From baseline to end of session at one hour
Bilateral hip flexion, extension and abduction, knee flexion and extension, ankle plantarflexion, dorsiflexion, inversion and eversion range of motion measurements were taken in supine or prone (whichever was appropriate) using a goniometer.
Lower Extremity Power Horizontal Jump
Time frame: From baseline to end of session at one hour
Lower extremity power was measured by completing three trials of horizontal jump testing using a Woanger 12'x2.5' long jump mat with the distance verified by a secondary measure using a tape measure with one warm up first and 90 seconds to recover between each jump.
Lower Extremity Power Vertical Jump
Time frame: From baseline to end of session at one hour
Lower extremity power was measured by completing three trials of vertical jump testing using a Fleage Floor standing vertical jump measurement tester with one warm up first and 90 seconds to recover between each jump.
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 24 Sep 2024.
- Individual participant dataSharing planned: No. The individual participant data is not the main focus of this study. The overall findings of the study with the larger number of participants to look at the trend is what will be shared (presented or published). The IRB proposal for this study included confidentiality of each individual participant as that will be maintained, but the global findings are what will be shared after data analysis for comparison.
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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.
Beth Marschner, DPT principal investigator
Minot State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Beth Marschner at 1 site in United States.
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 8 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 24 Sep 2024. 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 United States. 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?
Range of Motion (time frame: From baseline to end of session at one hour). The study lists 3 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 24 Sep 2024.