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
|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
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
||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|
|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.|
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|
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|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||
|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|
|NCT Number ICMJE||NCT03080220|
|Other Study ID Numbers ICMJE||160231-03|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Andrew Doyle, Rocky Mountain University of Health Professions|
|Study Sponsor ICMJE||Rocky Mountain University of Health Professions|
|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