Effects of Instrument Assisted Soft Tissue Mobilization Regarding Range of Motion and Lower Extremity Power ((IASTM))

September 19, 2024 updated by: Beth Marschner

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IASTM First
This arm of the study received IASTM treatment on the first day and the wait/control on the second day of the study
Other: Instrument Assisted Soft Tissue Mobilization first Control second
Instrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day.
Experimental: Wait/control First
This arm of the study waited (was the control) on the first day and received IASTM treatment on the second day of the study.
Other: Control first Instrument Assisted Soft Tissue Mobilization second
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to end of session at one hour
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.
From baseline to end of session at one hour
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.
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

Beth Marschner

Collaborators

Minot State University

Investigators

  • 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)

January 8, 2024

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2428

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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