Athletic InjuriesNCT03594669
Training for Injury Prevention in Collegiate Soccer Players
A study testing Intervention in people with Athletic Injuries, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Sensorimotor Training for Injury Prevention in Collegiate Soccer Players
The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.
Read the 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.
- Conditions
- Athletic Injuries
- Being tested
- Intervention
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Multi-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical measures of sensorimotor control
Clinical examination tests
Measured: Pre to post-treatment (1 month)
Secondary outcomes (1)
Injury incidence rate
- 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start11 Aug 2018
- Primary completion15 Dec 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mississippi College
- Responsible party
- Principal investigator, Jennifer C. Reneker, University of Mississippi Medical Center
- Investigators
- Jennifer C Reneker, PT, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594669
- Sponsor's protocol ID
- 17-0232
- Status last verified
- Sep 2019
- First submitted
- 11 Jul 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Training for Injury Prevention in Collegiate Soccer Players
- ClinicalTrials.gov ID
- NCT03594669
- Acronym / sponsor ID
- 17-0232
- Conditions
- Athletic Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Mississippi College
- Study start
- 11 Aug 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionMulti-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises. | Other | Intervention |
Primary outcome
Change in clinical measures of sensorimotor control
Time frame: Pre to post-treatment (1 month)
Clinical examination tests
1 secondary outcome
Injury incidence rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Reneker, PT, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Athletic Injuries, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical measures of sensorimotor control (time frame: Pre to post-treatment (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.