NCT03594669

Brief Summary

The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

August 11, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

July 11, 2018

Last Update Submit

September 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in clinical measures of sensorimotor control

    Clinical examination tests

    Pre to post-treatment (1 month)

Secondary Outcomes (1)

  • Injury incidence rate

    1 year

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Other: Intervention

Interventions

Multi-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Interventions

Methods

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jennifer C Reneker, PT, PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking will be used
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

August 11, 2018

Primary Completion

December 15, 2018

Study Completion

August 1, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations