Primary Prevention of Concussion in Youth Ice Hockey Players

Concussion Clinical Trial

Official title:

Primary Prevention of Concussion in Youth Ice Hockey Players

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360786
• Other study ID #: Conc-PT-03
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: November 27, 2017
• Start date: October 4, 2017
• Est. completion date: December 29, 2018

Study information

• Verified date: November 2017
• Source: Sport Injury Prevention Research Centre
• Contact: Kathryn J Schneider, PT, PhD
• Phone: 403 210 8951
• Email: kjschnei[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 29, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Concussion

Intervention

Other:
• Specific intervention
Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education
• Control intervention
Education on concussion and concussion identification in addition to typical cardiovascular warmups

Locations

Country	Name	City	State
Canada	University of Calgary Sport	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Sport Injury Prevention Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months (length of hockey season)
Primary	Number of participants able to complete protocol.	Number of participants completing each intervention will be calculated	6 months (length of hockey season)
Secondary	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	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Numeric Pain Rating Scale for Neck pain	Neck pain rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Numeric Pain Rating Scale for Headache	Headache pain rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Numeric Dizziness Rating Scale	Dizziness rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	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)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Dynamic Visual Acuity (DVA)	Clinical test of dynamic visual acuity using ETDRS chart	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Head Thrust Test (HTT)	Clinical test to evaluate ability to maintain eyes on a stationary target. Performed to right and left. (+ve/-ve)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	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	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	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	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Walking While Talking Test (WWTT)	Test of walking and performing cognitive tasks of increasing difficulty, Time (seconds) for each task is recorded.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	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)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Cervical Flexion Rotation Test (CFRT)	Screening test for upper cervical spine involvement. Positive/negative and is performed to both right and left.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Anterolateral cervical spine strength	Measured using a head held dynamometer with subject in supine position. Test is repeated 3 times. Output measured in kg.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Head perturbation test (HPT)	Ability to maintain head in a neutral position with external perturbation applied. Score out of 8 is recorded	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Secondary	Vestibular/Ocular Motor Screening Assessment (VOMS)	As per Mucha et al, 2014	Time 0, 4 weeks, end of hockey season (approximately 6 months)