Serial Movement Assessment in Collegiate Athletes Who Perform Injury Prevention Training

March 29, 2024 updated by: Eleanor Beltz, Northern Vermont University

Serial Movement Assessment in Athletes Who Perform Injury Prevention Training

Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is critical. Movement quality during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Movement quality can be improved through exercise-based injury prevention training, thereby decreasing injury risk. This purposed of this study is to evaluate movement quality multiple times over the course of an athletic season in collegiate athletes who perform injury prevention training. The hypothesis is that movement quality will improve over the course of an athletic season.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neuromuscular control, or quality of movement, during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Neuromuscular control can be improved through exercise-based injury prevention training (called preventive training programs, or PTPs), thereby decreasing injury risk. Neuromuscular control is dynamic and therefore should be evaluated regularly; however, no study has serially evaluated neuromuscular control in athletes who perform PTPs. The overall objective of the proposed study is to longitudinally evaluate multiple aspects of neuromuscular control (i.e., movement quality, balance) across several time points during a single athletic season in collegiate athletes who perform PTPs. Therefore, two specific aims are proposed: Specific Aim 1: Evaluate neuromuscular control at multiple time points during an athletic season in collegiate athletes who perform PTPs. Specific Aim 2: Evaluate multiple measures of neuromuscular control over the course of an athletic season in collegiate athletes who perform PTPs. A field-based, experimental, cohort study will be used to address both specific aims. Subjects will be recruited from NCAA-Division III men's and women's soccer, volleyball and basketball teams. Neuromuscular control will be assessed four times during the athletic season using the Landing Error Scoring System (LESS), the Balance Error Scoring System (BESS), and the Star Excursion Balance Test (SEBT). The LESS evaluates movement quality, while the BESS and the SEBT evaluate static and dynamic balance, respectively. Subjects will perform PTPs for about 10 minutes/day, at least 4 days/week.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Vermont
      • Johnson, Vermont, United States, 05665
        • Northern Vermont 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • National Collegiate Athletics Association (NCAA) Division III Athlete
  • Coach and athletic trainer elect to receive injury prevention services
  • Ages 18-24

Exclusion Criteria:

-Does not participate on NCAA Division III Athletic Team

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Injury Prevention Arm
exercise-based neuromuscular training injury prevention program
Other: Exercise-based injury prevention program
~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Landing Error Scoring System (LESS) Score
Time Frame: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
number of errors; scale is 0-17; lower score indicates better outcome
assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
Balance Error Scoring System (BESS) Score
Time Frame: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
number of errors; scale is 0-60; higher score indicates worse outcome
assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Vermont University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eleanor Beltz, PhD, ATC, Northern Vermont 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Beltz FAW2122 NMC PTP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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