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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03360786
Other study ID # Conc-PT-03
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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