Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Gait ((IASTM))

September 23, 2024 updated by: Beth Marschner

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

No further information to note than what is described in the summary or elsewhere

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Minot, North Dakota, United States, 58707
        • Minot State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals from a small regional university student body, faculty and staff may choose to volunteer to participate in this study.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IASTM
This arm of the study received treatment on day one and walking treatment on day two.
Other: Instrument Assisted Soft Tissue Mobilization
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.
Other Names:
  • HawkGrips
Other: Walking Treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to end of session at one hour
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.
From baseline to end of session at one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Marschner

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Minot State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth Marschner, DPT, Minot State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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