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Examining the Effects of Three Soft Tissue Treatments on Functional Movement and Functional Performance Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080220
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborators:
Performance Dynamics
Indiana Athletic Trainers' Association
Information provided by (Responsible Party):
Andrew Doyle, Rocky Mountain University of Health Professions

Tracking Information
First Submitted Date  ICMJE March 11, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date March 20, 2017
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
  • Vertical Jump [ Time Frame: 1 day ]
    A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study.28
  • Dynamic Balance [ Time Frame: 1 day ]
    A Y Balance test kit will be used to measure the distance reached while the participant stabilizes on one leg.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
Rating of Perceived Lower Extremity Function [ Time Frame: 1 day ]
The participant will be asked to rate current perceived lower extremity function on a 100mm line anywhere between 'my function is at its worst' and 'my function is at its best.' The participant will rate by placing a vertical line that intersects the 100mm horizontal line perpendicularly. A standard metric ruler will be used to measure from the farthest left to the intersecting line. This distance will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining the Effects of Three Soft Tissue Treatments on Functional Movement and Functional Performance Enhancement
Official Title  ICMJE Effects of Pre-Event Soft Tissue Treatment on Functional Movement and Functional Performance
Brief Summary The purpose of this study is to investigate the effects of Astym® treatment, The Stick® treatment and massage treatment on performance among healthy college athletes and to investigate any relationship between functional movement and functional performance. Participants will be recruited from Division II, National Association of Intercollegiate Athletics (NAIA) basketball and volleyball teams. The participants will be randomized into one of three groups: Astym treatment (AT), The Stick treatment (ST) or massage treatment (MT). The participant will have baseline measures of vertical jump (VJ), Y-Balance Lower Quarter Screen (YBLQ), and a rating of current perceived lower extremity function using a visual analog scale (PLEF-VAS). The participants will be treated using either the AT, ST, or MT following baseline measures. Immediately following the intervention, a second measurement of VJ, YBLQ, and PLEF-VAS will take place. The data will be analyzed using mixed ANOVA tests which will be conducted for each dependent variable. In addition, functional movement is thought to be related to functional performance. A Pearson Product Correlation analysis will be used to understand any relationship between YBLQ and VJ. It is hypothesized that those in the AT group will have different percent change in their YBLQ, VJ, and PLEF-VAS compared to those in ST and MT groups. It is hypothesized that a correlation between YBLQ and VJ will exist. As a result, clinicians could use AT among basketball and volleyball athletes without hindering acute performance. Any risks the participants could encounter are minimal. Participants may withdraw themselves and their data at any time. The intervention and testing are similar to what an athlete would be exposed to during their collegiate career. Any participant injured during this study will be referred to their university sports medicine staff, health center, or the Indiana Wesleyan University health center.
Detailed Description

All participants will complete baseline testing, intervention, and post intervention testing in a single day. The total time for a participant to complete the entire study is anticipated to be between 1.5 and 2 hours. Upon arrival to the Athletic Training Clinic, a participant's demographic information will be collected. This information will consist of the following: age, weight, height, and percent body fat using a standard seven site skinfold measurement. Other information will be recorded, such as sport, position, gender, years of college sport experience, and year in school. The research team will ensure that the participant is dressed appropriately in athletic shorts and T-shirt. Spandex® or compression type garments will not be allowed to be worn at any time during the study.

Once the demographic information is collected, a full body warm up will be initiated. Participants will be instructed to warm up on a bike for 5 minutes at an intensity of 4 to 6 as represented on the OMNI scale of perceived exertion. This warm up is based on the guidelines set forth by the American College of Sports Medicine. Following the warm up, each participant's baseline measurements will be taken in this order: Vertical Jump (VJ), Y-Balance Lower Quarter (YBLQ), and rating of Perceived Lower Extremity Function-Visual Analog Scale (PLEF-VAS).

Following baseline data collection, participants will be randomly assigned to an intervention. One of the three treatments previously described will take place in the Athletic Training Clinic. An individual not associated with the research committee or research team will conduct the randomization. Immediately following the intervention, participants will proceed to the performance evaluation testing area for post treatment testing. The participant may elect to bring one chaperon of their choosing to the treatment area. Warm up and performance testing order will remain consistent for each participant and will follow the order as conducted during baseline measure.

Trained undergraduate research assistants, blinded from the treatment allocation will collect the testing data. The testing data will include: the VJ, YBLQ, and the PLEF-VAS. The clinicians (doctoral candidate and assisting clinician) will provide Astym treatment (AT), The Stick treatment (ST), or massage treatment (MT) and will not be present for the VJ, YBLQ, and the PLEF-VAS nor will the clinicians providing the intervention be present in the testing area during baseline test collection.

Testing Procedures Participants will perform the VJ and YBLQ Screen following a 5-minute-warm up as previously described. The highest jump of three attempts will be recorded for the counter movement VJ. The longest reach of three attempts in the anterior, posteriolateral and posteromedial directions will be recorded following the established YBLQ protocol.

Vertical Jump A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study. The participant is positioned on a mat with a belt placed around the waist. The belt has a tape measure running form the belt to the mat. The participant is asked to stand erect to establish 'zero'. The participant then jumps vertically while the belt is around the waist pulling out the remaining tape measure. The vertical jump height is recorded as the displacement of the tape measure. The participant will propel vertically as high as possible. A preparatory stutter step will not be used; however, a counter movement may be used. A countermovement is where the participant quickly flexes the knees and hips while moving the thorax forward and downward while swinging the arms back. Three jump attempts will be given to each participant where a measurement will take place after each attempt. Measurements will be recorded to the nearest half inch and then converted to centimeters. The highest measurement will be used for analysis.

Y Balance Lower Quarter Screen Testing procedures for the YBLQ (Y Balance Test Kit, Move2Perform; Evansville, IN) will follow the protocol previously established by researchers The participant will have viewed a two minute instructional video prior to practicing six reaches in each of the three directions bilaterally: anterior, posteriormedial and posteriorlateral. Following the practice reaches, the participant will stand on the Y Balance center footplate with the right foot behind the start line. With the free foot, the participant will reach in the anterior direction pushing the indicator box as far as possible. Three successful measurements in as many as six attempts in the reach direction will be recorded with the best, successful reach being used for analysis. The participant will then switch stance legs. The indicator box will be reset and the participant will reach with the right foot in the anterior direction. This cycle will continue for the posteromedial and posterolateral directions. Successful reaches are those where the participant maintained contact with stance leg on the center footplate and behind the start line throughout the reach attempt. Successful reaches also will include maintaining contact with the indicator box during the reach attempt, not using the indicator box for support, and returning to start position under control. The participant will rest only as long as it takes the recorder to reset the indicator box and log the reach distance.

Rating of Perceived Lower Extremity Function The participant will be asked to rate current perceived lower extremity function on a 100mm line anywhere between 'my function is at its worst' and 'my function is at its best.' The participant will rate by placing a vertical line that intersects the 100mm horizontal line perpendicularly. A standard metric ruler will be used to measure from the farthest left to the intersecting line. This distance will be recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Functional Performance
Intervention  ICMJE
  • Device: Astym
    therapeutic massage instrument
  • Device: Stick
    massage instrument
    Other Name: The Stick
  • Device: Massage
    massage instruments
Study Arms  ICMJE
  • Experimental: Astym
    The Astym treatment (AT) is specifically used by medical professionals to treat musculoskeletal dysfunctions by stimulating the body's ability to break down adhesions and reabsorb dysfunctional tissue (scar tissue).6-16,19 The treatment induces collagen building, fibroblastic activity, and phagocytosis.17,18 Part of the treatment includes utilizing a series of instruments glided across the skin tissue, in a non-invasive manner, along the route of the underlying muscle fibers' direction. The treatment specifically spares healthy tissue and stimulates growth factors and cellular mediators that stimulate the repair of dysfunctional tissue in the body's internal mechanisms.17,18 Astym is an FDA approved device. Specifically, Astym is registered as having a device class as 1 and regulation number as 890.5660.
    Intervention: Device: Astym
  • Experimental: Stick
    The Stick treatment (ST) utilizes an instrument to convert non-compliant muscle to compliant muscle by compressing the muscle. The individual spindles of The Stick create a stripping massage by applying progressively deeper strokes over the soft tissue.38 The Stick permits individuals to perform trigger point release on own person, allowing the muscle to become compliant to the wanted movement.
    Intervention: Device: Stick
  • Placebo Comparator: Massage
    Similar to the protocol previously outlined for the other two independent variables, the massage treatment (MT) will progress from anterior, to medial, to lateral and posterior shank, thigh, and hip. The treatment on each muscle tissue will follow the similar protocol as the Astym treatment (AT) group. However, the flat, non-treatment edge of the Evaluator®, Localizer®, and Isolator® will be put in contact with the muscle tissues in a direction parallel to the muscle fibers being treated, but without over pressure.7 The traditional treatment edge of the instrument has a tapered, machine edge and creates shear forces when glided across the tissue at an angle between 60 and 80 degrees.
    Intervention: Device: Massage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2017)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male and female athletes
  • individuals aged between 18 and 25 years
  • compete in basketball or volleyball sponsored by the NAIA Division II governing body during the 2015 - 2016 or 2016 - 2017 athletic seasons
  • sport eligible.

Exclusion Criteria:

  • Astym treatment (AT) in last 3 weeks
  • The Stick treatment (ST) in the last 3 weeks
  • Massage treatment (MT) in thelast 3 weeks
  • Participants using other means of instrument assisted cutaneous tissue preparation techniques such as 'scraping' household items or stainless steel objects along the lower kinetic chain tissue.
  • Currently injured or ill
  • Injured in the last month before the participation date
  • Not full healed from a previous injury or illness
  • Participants who currently have athletic participation restrictions of any kind - Those who have known clotting dysfunctions
  • Those on anticoagulation therapies
  • Those with neurogenic dysfunctions
  • Those who may be pregnant
  • Those allergic to cocoa butter.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080220
Other Study ID Numbers  ICMJE 160231-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this point.
Responsible Party Andrew Doyle, Rocky Mountain University of Health Professions
Study Sponsor  ICMJE Rocky Mountain University of Health Professions
Collaborators  ICMJE
  • Performance Dynamics
  • Indiana Athletic Trainers' Association
Investigators  ICMJE
Principal Investigator: Andrew T Doyle, MA Rocky Mountain University of Health Professions/Indiana Wesleyan University
PRS Account Rocky Mountain University of Health Professions
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP