ConcussionNCT03360786
Primary Prevention of Concussion in Youth Ice Hockey Players
A study testing Specific intervention in people with Concussion, run by Sport Injury Prevention Research Centre at 1 site in Canada.
Trial summary
1. Background and Rationale: Little is currently known about intrinsic risk factors for sport-related concussion in youth ice hockey players. Emerging research suggests that alterations in cervical and balance function increase the risk of concussion in youth ice hockey players. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Specific intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2017to 29 Dec 2018
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.
Who cannot join
- Inability to participate in physical activity for a reason other than sport related concussion.
- Inability to communicate in English language.
- Neurodevelopmental delays expected to affect ability to adapt with treatment.
- Orthopaedic or other injury affecting ability to participate.
- Medication known to affect neural adaptation as they may alter the response to treatment.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary Sport
Calgary, Alberta, T2N 1N4
Kathryn Schneider, PT, PhD, (403) 210-8951, kjschnei@ucalgary.ca
Carolyn Emery, PT, PhD, 403-220-4608, caemery@ucalgary.ca
About this study
- Background and Rationale: Little is currently known about intrinsic risk factors for sport-related concussion in youth ice hockey players. Emerging research suggests that alterations in cervical and balance function increase the risk of concussion in youth ice hockey players. Thus, evaluation of a primary prevention program aimed at addressing alterations in cervical and vestibular function may result in a protective effect in reducing the risk of concussion. Such a program targeting intrinsic risk factors for concussion has not previously been evaluated and thus a pilot Randomized control trial (RCT) to inform the feasibility and efficacy of such a program is needed prior to proceeding to evaluation of such a program on a larger scale.
- Research Question and Objectives The primary objectives of this pilot RCT study are: 1) To evaluate the feasibility of a concussion prevention program in youth ice hockey players; and 2) To evaluate the efficacy of a concussion prevention program in decreasing the risk of concussion. Exploratory objectives include evaluating the changes in quality of life, clinical measures of cervical and vestibular function measures and Hockey Canada on-ice skills testing in youth ice hockey players following a concussion prevention program.
- Methods
This study will be a pilot RCT. Prior to the 2017 hockey season, 120 players from 8 youth ice hockey teams ages 13-17 will be recruited to participate. Once parental consent and/or player assent has been obtained, players will complete a series of initial intake forms. Baseline tests and measures, including a standardized preseason baseline questionnaire (regarding playing history, past medical history, participation in sport) and a battery of questionnaires and clinical measures. Individuals will be randomly allocated into either a control protocol (general cardiovascular warm-up, general stretching and strengthening, education on concussion identification) or a specific protocol (balance, neuromotor control, strength, vestibulo-ocular and oculomotor training + concussion education). Both groups will meet with the study physiotherapist once weekly for 4 weeks and exercises will be progressed. A previously validated prospective injury surveillance system will be implemented. As part of this process, a team designate will collect data throughout the season regarding individual player participation in games, practices and dry land training sessions. Individuals with a suspected concussion will be referred to the study sport medicine physician for evaluation, diagnosis and standard of care management. At this time all baseline tests and measures will be repeated.
- Conditions
- Concussion
- Being tested
- Specific intervention, Control intervention
- Keywords
- sport concussion, cervical spine, youth
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific interventionOther
Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education
Control interventionOther
Education on concussion and concussion identification in addition to typical cardiovascular warmups
| Study group | Role | What they receive |
|---|---|---|
| Specific Protocol | Experimental | The intervention group will work with the study physiotherapist and perform a 10-20 minute progressive exercises twice per week. The intervention will include a series of exercises including dynamic balance, adaptation, cervical spine strength, cervical spine neuromotor control and divided attention exercises. Exercises will begin at a lower level and progress to increasingly difficult levels of each exercise type over the course of the intervention. Concussion education and injury identification will also be completed. Receives: Other: Specific intervention |
| Control Protocol | Active comparator | The control group will continue with their standard warm up and practice schedule but have the addition of contact time with the study physiotherapist for education regarding concussion education and injury identification. Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Concussion prevention protocol
A primary outcome of interest is diagnosis of concussion. This will be determined by the study sport medicine physician in accordance with current standards of care and as per the 5th International Consensus on Concussion in Sport Statement. Medical clearance to return to sport will be determined by the study sport medicine physician according to the 5th Consensus on Concussion in Sport Statement.
Measured: 6 months (length of hockey season)
Number of participants able to complete protocol.
Number of participants completing each intervention will be calculated
Measured: 6 months (length of hockey season)
Secondary outcomes (15)
Pediatric Quality of Life Scale (PedsQL)
The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury. 0-100/100
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Neck pain
Neck pain rated from 0-10/10
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Headache
Headache pain rated from 0-10/10
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Dizziness Rating Scale
Dizziness rated from 0-10/10
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Sport Concussion Assessment Tool 5 (SCAT5)
Multifaceted assessment tool including symptom reports (rated 0-6 for 22 different symptoms), Cognitive Screen (score /30), Neurological screen (Y/N for 5 questions and balance exam /30)
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Dynamic Visual Acuity (DVA)
Clinical test of dynamic visual acuity using ETDRS chart
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head Thrust Test (HTT)
Clinical test to evaluate ability to maintain eyes on a stationary target. Performed to right and left. (+ve/-ve)
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Functional Gait Assessment (FGA)
Dynamic balance measure including 10 different walking tasks that are rated on a scale of 0-3 for a total score out of 30
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Advanced Functional Gait Assessment (A-FGA)
Newly created balance measure that represents a more difficult measure of dynamic balance and is a combination of progressively more difficult tasks included in the FGA. Clinician rated score 0-3 for each task. Total score out of 18
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Walking While Talking Test (WWTT)
Test of walking and performing cognitive tasks of increasing difficulty, Time (seconds) for each task is recorded.
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Endurance test (CFE)
Test performed in crook lying that measures the ability of a subject to maintain head in a craniovertebral flexion position and slightly lifted off pillow. Time (seconds)
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Rotation Test (CFRT)
Screening test for upper cervical spine involvement. Positive/negative and is performed to both right and left.
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Anterolateral cervical spine strength
Measured using a head held dynamometer with subject in supine position. Test is repeated 3 times. Output measured in kg.
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head perturbation test (HPT)
Ability to maintain head in a neutral position with external perturbation applied. Score out of 8 is recorded
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Vestibular/Ocular Motor Screening Assessment (VOMS)
As per Mucha et al, 2014
Measured: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start4 Oct 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion29 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn J Schneider, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360786
- Sponsor's protocol ID
- Conc-PT-03
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to share individual participant data with others outside of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Concussion in Youth Ice Hockey Players
- ClinicalTrials.gov ID
- NCT03360786
- Acronym / sponsor ID
- Conc-PT-03
- Conditions
- Concussion
- Keywords
- sport concussion, cervical spine, youth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 29 Dec 2018 (estimated)
- First posted
- 4 Dec 2017 (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.
- Background and Rationale: Little is currently known about intrinsic risk factors for sport-related concussion in youth ice hockey players. Emerging research suggests that alterations in cervical and balance function increase the risk of concussion in youth ice hockey players. Thus, evaluation of a primary prevention program aimed at addressing alterations in cervical and vestibular function may result in a protective effect in reducing the risk of concussion. Such a program targeting intrinsic risk factors for concussion has not previously been evaluated and thus a pilot Randomized control trial (RCT) to inform the feasibility and efficacy of such a program is needed prior to proceeding to evaluation of such a program on a larger scale.
- Research Question and Objectives The primary objectives of this pilot RCT study are: 1) To evaluate the feasibility of a concussion prevention program in youth ice hockey players; and 2) To evaluate the efficacy of a concussion prevention program in decreasing the risk of concussion. Exploratory objectives include evaluating the changes in quality of life, clinical measures of cervical and vestibular function measures and Hockey Canada on-ice skills testing in youth ice hockey players following a concussion prevention program.
- Methods
This study will be a pilot RCT. Prior to the 2017 hockey season, 120 players from 8 youth ice hockey teams ages 13-17 will be recruited to participate. Once parental consent and/or player assent has been obtained, players will complete a series of initial intake forms. Baseline tests and measures, including a standardized preseason baseline questionnaire (regarding playing history, past medical history, participation in sport) and a battery of questionnaires and clinical measures. Individuals will be randomly allocated into either a control protocol (general cardiovascular warm-up, general stretching and strengthening, education on concussion identification) or a specific protocol (balance, neuromotor control, strength, vestibulo-ocular and oculomotor training + concussion education). Both groups will meet with the study physiotherapist once weekly for 4 weeks and exercises will be progressed. A previously validated prospective injury surveillance system will be implemented. As part of this process, a team designate will collect data throughout the season regarding individual player participation in games, practices and dry land training sessions. Individuals with a suspected concussion will be referred to the study sport medicine physician for evaluation, diagnosis and standard of care management. At this time all baseline tests and measures will be repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Protocol | Experimental | Other: Specific interventionThe intervention group will work with the study physiotherapist and perform a 10-20 minute progressive exercises twice per week. The intervention will include a series of exercises including dynamic balance, adaptation, cervical spine strength, cervical spine neuromotor control and divided attention exercises. Exercises will begin at a lower level and progress to increasingly difficult levels of each exercise type over the course of the intervention. Concussion education and injury identification will also be completed. |
| Control Protocol | Active comparator | Other: Control interventionThe control group will continue with their standard warm up and practice schedule but have the addition of contact time with the study physiotherapist for education regarding concussion education and injury identification. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.
Key exclusion criteria (5 listed)
- Inability to participate in physical activity for a reason other than sport related concussion.
- Inability to communicate in English language.
- Neurodevelopmental delays expected to affect ability to adapt with treatment.
- Orthopaedic or other injury affecting ability to participate.
- Medication known to affect neural adaptation as they may alter the response to treatment.
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 |
|---|---|---|
| Specific interventionSeries of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education | Other | Specific Protocol |
| Control interventionEducation on concussion and concussion identification in addition to typical cardiovascular warmups | Other | Control Protocol |
Primary outcome
Efficacy of Concussion prevention protocol
Time frame: 6 months (length of hockey season)
A primary outcome of interest is diagnosis of concussion. This will be determined by the study sport medicine physician in accordance with current standards of care and as per the 5th International Consensus on Concussion in Sport Statement. Medical clearance to return to sport will be determined by the study sport medicine physician according to the 5th Consensus on Concussion in Sport Statement.
Number of participants able to complete protocol.
Time frame: 6 months (length of hockey season)
Number of participants completing each intervention will be calculated
15 secondary outcomes
Pediatric Quality of Life Scale (PedsQL)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Neck pain
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Headache
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Dizziness Rating Scale
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Sport Concussion Assessment Tool 5 (SCAT5)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Dynamic Visual Acuity (DVA)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head Thrust Test (HTT)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Functional Gait Assessment (FGA)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Advanced Functional Gait Assessment (A-FGA)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Walking While Talking Test (WWTT)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Endurance test (CFE)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Rotation Test (CFRT)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Anterolateral cervical spine strength
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head perturbation test (HPT)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Vestibular/Ocular Motor Screening Assessment (VOMS)
Time frame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No. At this time there is no plan to share individual participant data with others outside of the research team.
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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.
Kathryn J Schneider, PT, PhD principal investigator
Sport Injury Prevention Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific intervention in people with Concussion, run by Sport Injury Prevention Research Centre at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Dec 2017. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn J Schneider, PT, PhD (403 210 8951, kjschnei@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Concussion prevention protocol (time frame: 6 months (length of hockey season)). The study lists 2 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 4 Dec 2017.