Healthy(IASTM)NCT06612983
Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Gait
A study testing Instrument Assisted Soft Tissue Mobilization and Walking Treatment in people with 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 tissue of 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 ankle and knee? Does IASTM treatment have an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Walking Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 28 Feb 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 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
The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy tissue of 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 ankle and knee?
- Does IASTM treatment have an effect on movement patterns including gait - how a person walks? Researchers will compare pre-test and post-test data from the same individual on their day with treatment to the pre-test and post-test data from the same individual on their day without treatment to see if ROM or gait are effected by use of IASTM.
Read more
Participants will:
- Complete a past medical and injury history questionnaire
- Have ankle and knee range of motion (ROM) measurements taken on both lower extremities using a goniometer
- Undergo a gait analysis to determine center of gravity, center of pressure, step length, stride length, and stride frequency using Noraxon MyoMuscle Ultium Insoles
- Undergo IASTM treatment techniques using the HawkGrips tools including applying emollient to the skin to reduce friction on the surface followed by scanning the gastroc/soleus complexes and Achilles tendons using the HG8-Scanner tool for 15 strokes in each direction to identify areas of concern, 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. Treatment techniques should last for 10 minutes in total on each side.
- Complete the ankle and knee ROM measurements as well as gait analysis again to document progress at the end of the first session.
- Return three to seven days after the first session in which the subject will have the walking treatment.
- Undergo the same baseline pre-test measurements for range of motion and gait analysis as the first session
- Experience the walking treatment by walking for the same time period that the IASTM treatment took at the first session
- Undergo the post-test range of motion and gait analysis 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, Walking Treatment
- Keywords
- Instrument assisted soft tissue mobilization, Range of Motion, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
Also called HawkGrips
Instrument assisted soft tissue mobilization is a technique that is applied using specially designed tools/instruments to provide a mobilizing effect to soft tissues including the skin, fascia, muscles, and tendons by its various direct compressive stroke techniques on the gastroc/soleus complexes and Achilles tendons in the first session.
Walking TreatmentOther
Movement itself should promote mobility so walking steadily for the same period of time as the IASTM had taken to complete is the sham treatment in second session.
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | This arm of the study received treatment on day one and walking treatment on day two. Receives: Other: Instrument Assisted Soft Tissue Mobilization; Other: Walking Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Bilateral knee flexion and extension as well as ankle plantarflexion, dorsiflexion, inversion and eversion range of motion measurements were taken in supine using a goniometer.
Measured: From baseline to end of session at one hour
Gait
Gait analysis was conducted using Noraxon MyoMuscle System with Ultium insoles placed in the participants shoes. The software collected data on center of gravity, center of pressure, step length, stride length, and stride frequency.
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 posted25 Sep 2024
- Study start9 Jan 2023
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will experience the IASTM treatment first and the first session and the walking - sham treatment at the second session.
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT06612983
- Sponsor's protocol ID
- 2242
- Acronym
- (IASTM)
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 25 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 25 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 Gait
- ClinicalTrials.gov ID
- NCT06612983
- Acronym / sponsor ID
- (IASTM) / 2242
- Conditions
- Healthy
- Keywords
- Instrument assisted soft tissue mobilization, Range of Motion, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beth MarschnerUniversity, hospital or other
- Collaborators
- Minot State University
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 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 tissue of 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 ankle and knee?
- Does IASTM treatment have an effect on movement patterns including gait - how a person walks? Researchers will compare pre-test and post-test data from the same individual on their day with treatment to the pre-test and post-test data from the same individual on their day without treatment to see if ROM or gait are effected by use of IASTM.
Participants will:
- Complete a past medical and injury history questionnaire
- Have ankle and knee range of motion (ROM) measurements taken on both lower extremities using a goniometer
- Undergo a gait analysis to determine center of gravity, center of pressure, step length, stride length, and stride frequency using Noraxon MyoMuscle Ultium Insoles
- Undergo IASTM treatment techniques using the HawkGrips tools including applying emollient to the skin to reduce friction on the surface followed by scanning the gastroc/soleus complexes and Achilles tendons using the HG8-Scanner tool for 15 strokes in each direction to identify areas of concern, 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. Treatment techniques should last for 10 minutes in total on each side.
- Complete the ankle and knee ROM measurements as well as gait analysis again to document progress at the end of the first session.
- Return three to seven days after the first session in which the subject will have the walking treatment.
- Undergo the same baseline pre-test measurements for range of motion and gait analysis as the first session
- Experience the walking treatment by walking for the same time period that the IASTM treatment took at the first session
- Undergo the post-test range of motion and gait analysis 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will experience the IASTM treatment first and the first session and the walking - sham treatment at the second session.
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Other: Instrument Assisted Soft Tissue Mobilization, Other: Walking TreatmentThis arm of the study received treatment on day one and walking treatment on day two. |
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 MobilizationAlso: HawkGripsInstrument assisted soft tissue mobilization is a technique that is applied using specially designed tools/instruments to provide a mobilizing effect to soft tissues including the skin, fascia, muscles, and tendons by its various direct compressive stroke techniques on the gastroc/soleus complexes and Achilles tendons in the first session. | Other | IASTM |
| Walking TreatmentMovement itself should promote mobility so walking steadily for the same period of time as the IASTM had taken to complete is the sham treatment in second session. | Other | IASTM |
Primary outcome
Range of Motion
Time frame: From baseline to end of session at one hour
Bilateral knee flexion and extension as well as ankle plantarflexion, dorsiflexion, inversion and eversion range of motion measurements were taken in supine using a goniometer.
Gait
Time frame: From baseline to end of session at one hour
Gait analysis was conducted using Noraxon MyoMuscle System with Ultium insoles placed in the participants shoes. The software collected data on center of gravity, center of pressure, step length, stride length, and stride frequency.
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 25 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 testing Instrument Assisted Soft Tissue Mobilization and Walking Treatment in people with 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 25 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 2 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 25 Sep 2024.