Concussion, MildNCT04036916
Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II
A study testing Virtual Reality Sensorimotor Training in people with Concussion, Mild and Sport Injury, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion, Mild, Sport Injury
- What is being tested?
- Virtual Reality Sensorimotor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 10 Dec 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
- 18 years of age or older
- on the soccer roster who are eligible to play in the fall 2019 season at the participating institutions.
Who cannot join
- Current diagnosis of concussion (i.e. a non-medically cleared concussion)
- Current lower-extremity musculoskeletal injury,
- Seizure disorder with photo sensitivity
- Other medical diagnosis that will prevent 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
The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.
- Conditions
- Concussion, Mild, Sport Injury
- Being tested
- Virtual Reality Sensorimotor Training
- Keywords
- Concussion, Injury prevention
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Sensorimotor TrainingOther
Also called Cervical strength training
Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training (Experimental) | Experimental | Participants will receive multi-modal sensorimotor training interventions, including activities training the vestibular system, oculomotor control and visual perception, neuromotor control and strengthening of the cervical spine, postural control/ balance exercises, and exercises integrating the use of multiple types of sensory information for controlled motor output, including speed and accuracy. Novel headset virtual reality (VR) games/activities; compliant balance surfaces; resistance bands/weight; and biofeedback devices will be utilized to deliver the training intervention. 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 12 sessions over 6 weeks. Receives: Other: Virtual Reality Sensorimotor Training |
| No Virtual Reality Training (Control) | No intervention | True control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury incidence rate
Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures
Measured: approximately 16 weeks
Game Performance
Game performance will be analyzed through video recording of the 2019 season's games and analysis of performance metrics (performed by InStat). Key performance indices (with higher scores reflecting better performance during game play) will be used as the metric of game performance.
Measured: approximately 16 weeks
Standing Balance
Standing balance (as measured on the Sway balance app 0 - 100 scale)
Measured: Pre to post-intervention (approximately 6 weeks)
Reaction Time
Reaction time (as measured on the Sway balance app) including impulse control; inspection time; and simple reaction time
Measured: Pre to post-intervention (approximately 6 weeks)
Oculomotor Control
Accuracy and latency of saccadic eye movements and smooth pursuit eye movements in response to an object presented to the participant on a computer screen (as measured by the Tobii eye tracker)
Measured: Pre to post-intervention (approximately 6 weeks)
Near-Point Convergence
Distance of point of near-binocular convergence (as measured in centimeters)
Measured: Pre to post-intervention (approximately 6 weeks)
Cranial Cervical Flexion Test
Cranial-cervical flexion neuromotor control (as measured by performance on the Cranial Cervical Flexion Test, mmHg level of control with a 3 second hold on a biofeedback pressure cuff)
Measured: Pre to post-intervention (approximately 6 weeks)
Deep Neck Flexor Endurance Test
Cranial Cervical flexion endurance (measured in seconds)
Measured: Pre to post-intervention (approximately 6 weeks)
Isometric Neck Strength
Measured by a dynamometer in flexion, extension, rotation and side-bending, recorded as force produced in each direction
Measured: Pre to post-intervention (approximately 6 weeks)
Secondary outcomes (9)
Score on Smooth Pursuit VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to follow a moving object with eyes while tracing manually. Accuracy of manual trace produces total score. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Saccades VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to shift eyes to location of a presented visual stimulus and to activate the location with a manual control. Speed and accuracy of manual activation produces total score. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Near Point Convergence VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to follow a moving object with eyes while tracing manually. Accuracy of manual trace produces total score. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Joint Position Error VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity which is conducted according to the Clinical Joint Position Error Test. Accuracy of head relocation after 3 movements to the left, 3 to the right and 3 into extension produces total score. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Cervical Neuromotor Control VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to use head and neck movement control to trace a maze. Score is based on accuracy and speed of maze trace.
Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Postural Control (Balance) VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to maintain standing balance while visual scene in VR is tilting left and right. Score is based on postural sway as recorded by headset sensors. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Cervical Posture VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity. Requires participant to reproduce a chin-tucked position and hold for 5 seconds. Score is based on correct head alignment (as compared to starting position, measured by headset sensors) across 10 repetitions. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Visual Figure VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to visually search a complex scene to find a hidden object. Score is based on the number of correct manual identifications of the hidden object. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Score on Peripheral Vision VR Game
Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to focus on central object and use peripheral vision to identify the same object and indicate with a manual selection. Score is based on number of correct identifications. Higher score = better performance.
Measured: Pre to post-intervention (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start12 Aug 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of West Alabama, 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
- NCT04036916
- Sponsor's protocol ID
- 2019-0157
- Status last verified
- Mar 2020
- First submitted
- 23 Jul 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will have to obtain institutional approval prior to any data being shared externally. This has not been discussed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II
- ClinicalTrials.gov ID
- NCT04036916
- Acronym / sponsor ID
- 2019-0157
- Conditions
- Concussion, Mild, Sport Injury
- Keywords
- Concussion, Injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- University of West Alabama, Mississippi College
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 30 Jul 2019 (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 project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training (Experimental) | Experimental | Other: Virtual Reality Sensorimotor TrainingParticipants will receive multi-modal sensorimotor training interventions, including activities training the vestibular system, oculomotor control and visual perception, neuromotor control and strengthening of the cervical spine, postural control/ balance exercises, and exercises integrating the use of multiple types of sensory information for controlled motor output, including speed and accuracy. Novel headset virtual reality (VR) games/activities; compliant balance surfaces; resistance bands/weight; and biofeedback devices will be utilized to deliver the training intervention. 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 12 sessions over 6 weeks. |
| No Virtual Reality Training (Control) | No intervention | –True control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female athletes
- 18 years of age or older
- on the soccer roster who are eligible to play in the fall 2019 season at the participating institutions.
Key exclusion criteria (4 listed)
- Current diagnosis of concussion (i.e. a non-medically cleared concussion)
- Current lower-extremity musculoskeletal injury,
- Seizure disorder with photo sensitivity
- Other medical diagnosis that will prevent 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 |
|---|---|---|
| Virtual Reality Sensorimotor TrainingAlso: Cervical strength trainingGames/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck | Other | Virtual Reality Training (Experimental) |
Primary outcome
Injury incidence rate
Time frame: approximately 16 weeks
Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures
Game Performance
Time frame: approximately 16 weeks
Game performance will be analyzed through video recording of the 2019 season's games and analysis of performance metrics (performed by InStat). Key performance indices (with higher scores reflecting better performance during game play) will be used as the metric of game performance.
Standing Balance
Time frame: Pre to post-intervention (approximately 6 weeks)
Standing balance (as measured on the Sway balance app 0 - 100 scale)
Reaction Time
Time frame: Pre to post-intervention (approximately 6 weeks)
Reaction time (as measured on the Sway balance app) including impulse control; inspection time; and simple reaction time
Oculomotor Control
Time frame: Pre to post-intervention (approximately 6 weeks)
Accuracy and latency of saccadic eye movements and smooth pursuit eye movements in response to an object presented to the participant on a computer screen (as measured by the Tobii eye tracker)
Near-Point Convergence
Time frame: Pre to post-intervention (approximately 6 weeks)
Distance of point of near-binocular convergence (as measured in centimeters)
Cranial Cervical Flexion Test
Time frame: Pre to post-intervention (approximately 6 weeks)
Cranial-cervical flexion neuromotor control (as measured by performance on the Cranial Cervical Flexion Test, mmHg level of control with a 3 second hold on a biofeedback pressure cuff)
Deep Neck Flexor Endurance Test
Time frame: Pre to post-intervention (approximately 6 weeks)
Cranial Cervical flexion endurance (measured in seconds)
Isometric Neck Strength
Time frame: Pre to post-intervention (approximately 6 weeks)
Measured by a dynamometer in flexion, extension, rotation and side-bending, recorded as force produced in each direction
9 secondary outcomes
Score on Smooth Pursuit VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Saccades VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Near Point Convergence VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Joint Position Error VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Cervical Neuromotor Control VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Postural Control (Balance) VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Cervical Posture VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Visual Figure VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
Score on Peripheral Vision VR Game
Time frame: Pre to post-intervention (approximately 6 weeks)
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 24 Mar 2020.
- Individual participant dataSharing planned: No. I will have to obtain institutional approval prior to any data being shared externally. This has not been discussed.
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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 Virtual Reality Sensorimotor Training in people with Concussion, Mild and Sport Injury, 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 3 inclusion and 4 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 24 Mar 2020. 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?
Injury incidence rate (time frame: approximately 16 weeks). The study lists 9 primary outcomes in all. 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 24 Mar 2020.