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Training for Injury Prevention in Collegiate Soccer Players

Primary Purpose

Athletic Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Athletic Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College

Exclusion Criteria:

  • Any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

When enrolled into the study, the participants will be asked to join a group in WhatsApp for purposes of the research study. The application will be used to: deliver reminders for each treatment session; deliver daily prompts for the home exercise program; and present a web-link to the home exercise program (HEP). Participants will receive physical therapist delivered multi-modal sensorimotor training interventions. The exercises delivered at each intervention will be delivered in a group format, using a circuit of exercises that each athlete will complete in a session. Subsequent sessions will build upon previous sessions to work the sensorimotor control system in progressively more challenging and sport-specific scenarios. This present study will complete 8 sessions over 4 weeks.

Outcomes

Primary Outcome Measures

Change in clinical measures of sensorimotor control
Clinical examination tests

Secondary Outcome Measures

Injury incidence rate
b) The incidence rate ratio of injury rates between a historical control (2017 soccer season) and the 2018 soccer-season from the participating college's soccer teams.

Full Information

First Posted
July 11, 2018
Last Updated
September 11, 2019
Sponsor
University of Mississippi Medical Center
Collaborators
Mississippi College
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1. Study Identification

Unique Protocol Identification Number
NCT03594669
Brief Title
Training for Injury Prevention in Collegiate Soccer Players
Official Title
Sensorimotor Training for Injury Prevention in Collegiate Soccer Players
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
Mississippi College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.
Detailed Description
The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve and injury incidence rate will decrease after participation in an intervention aimed at restoration/refinement of sensorimotor control. This study will be conducted as a 1-arm intervention with pre- and post-participation measurement of sensorimotor control and completion of an exercise intervention. Statistical analyses will be completed to determine within group change pre-to post-intervention and injury risk by comparing injury rate in 2018 to injury rate of a historical control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will be conducted as pilot of a one-arm intervention using,1) pre- and post-participation measures of sensorimotor control and 2) injury incidence rate over the sports-season directly after completion of the intervention compared to injury incidence rate of a historical control (the 2017 soccer season at Mississippi College). Participants will include men and women athletes on soccer teams from one Division II institution.
Masking
None (Open Label)
Masking Description
No masking will be used
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
When enrolled into the study, the participants will be asked to join a group in WhatsApp for purposes of the research study. The application will be used to: deliver reminders for each treatment session; deliver daily prompts for the home exercise program; and present a web-link to the home exercise program (HEP). Participants will receive physical therapist delivered multi-modal sensorimotor training interventions. The exercises delivered at each intervention will be delivered in a group format, using a circuit of exercises that each athlete will complete in a session. Subsequent sessions will build upon previous sessions to work the sensorimotor control system in progressively more challenging and sport-specific scenarios. This present study will complete 8 sessions over 4 weeks.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Multi-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises.
Primary Outcome Measure Information:
Title
Change in clinical measures of sensorimotor control
Description
Clinical examination tests
Time Frame
Pre to post-treatment (1 month)
Secondary Outcome Measure Information:
Title
Injury incidence rate
Description
b) The incidence rate ratio of injury rates between a historical control (2017 soccer season) and the 2018 soccer-season from the participating college's soccer teams.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College Exclusion Criteria: Any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Reneker, PT, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Training for Injury Prevention in Collegiate Soccer Players

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