Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Grip Strength
(IASTM)
1 other identifier
interventional
72
1 country
1
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 elbow, wrist and thumb?
- Does IASTM treatment have an effect on grip strength? 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 ROM and/or grip strength. Participants will:
- Complete a questionnaire on medical history and injury background
- Have elbow, wrist, and thumb range of motion (ROM) measurements taken on both upper extremities using a goniometer
- Undergo grip strength testing using a JAMAR hand dynamometer in three positions on both upper extremities
- 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 forearm wrist flexors and wrist extensors and the biceps and triceps using the HG8-Scanner tool and 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) in each direction for a total treatment time of 20 minutes for both upper extremities in all listed areas.
- Simply wait for 20 minutes (the duration of time treatment with IASTM would require) when assigned to the control group.
- Complete elbow, wrist and thumb range of motion and grip strength measurement 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 grip strength as the first session.
- Experience the opposite treatment group for the same time period as the first session.
- Undergo the post-test range of motion and grip strength testing at the end of the second session for data comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jan 2024
Shorter than P25 for not_applicable healthy
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedFirst Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedSeptember 25, 2024
September 1, 2024
2 months
September 18, 2024
September 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Range of Motion
Bilateral elbow flexion and extension, wrist flexion, extension, ulnar deviation and radial deviation as well as thumb flexion, abduction and extension range of motion measurements were taken in sitting using a goniometer.
From baseline to end of session at one hour
Grip Strength
Grip strength was assessed bilaterally using a JAMAR hand dynamometer. Three positions were tested. First the participant flexed their shoulder to 90 degrees with the elbow kept straight. Then the participant kept their arm down and their side with the elbow bent to 90 degrees. Finally the participant kept their arm down and straightened the elbow. Three trials were used for each position.
From baseline to end of session at one hour
Study Arms (2)
IASTM First
EXPERIMENTALThis 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
EXPERIMENTALThis arm of the study waited (was the control) on the first day and received IASTM treatment on the second day of the study.
Interventions
Instrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day.
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.
Eligibility Criteria
You may qualify if:
- A volunteer from a small regional university student body, faculty or staff may participate.
You may not qualify if:
- Acute spinal cord injury with neurological deficits
- Neurological disorders
- Acute upper extremity injury such as sprain or strain
- Any type of upper extremity fracture within the past 12 months
- Cervical 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
- Beth Marschnerlead
- Minot State Universitycollaborator
Study Sites (1)
Minot State University
Minot, North Dakota, 58707, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Marschner, DPT
Minot State University
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 25, 2024
Study Start
January 8, 2024
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
September 25, 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.