NCT06610058

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 18, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

Instrument Assisted Soft Tissue MobilizationRange of MotionLower Extremity PowerVertical JumpHorizontal Jump

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    From baseline to end of session at one hour

Study Arms (2)

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

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.

Other: Control first Instrument Assisted Soft Tissue Mobilization second

Interventions

Instrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day.

IASTM First

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.

Wait/control First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minot State University

Minot, North Dakota, 58707, United States

Location

Study Officials

  • Beth Marschner, DPT

    Minot State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 24, 2024

Study Start

January 8, 2024

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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.

Locations