Sport Concussion Performance-Based Prevention Program

Sport-Related Concussion and Traumatic Lower Body Injury Performance-Based Prevention Program

Sport-related concussions and traumatic lower body injuries (e.g., anterior cruciate ligament (ACL) tears) occur frequently in high-speed and contact/collision sports contributing to significant time loss from training/competition and potentially devastating long-term performance and health consequences. Neurological impairment following a concussive injury may be subtle, but if missed, may have grave consequences in a high-risk, high-speed sporting context. Recent evidence suggests that the risk of lower body musculoskeletal injury is significantly higher for athletes sustaining a sport-related concussion in the three-month to two-year period following injury. Most injury prevention research to date has focused on modifiable extrinsic risk factors; there is a void or gap on modifiable intrinsic risk factors.

The purpose of this study is to:

1. determine the effect of a standardized supplementary pre-season multi-modal neurologic training program, versus usual training, on concussion and/or traumatic lower body injury risk among high-speed/contact/collision sport athletes (primary prevention).
2. determine the effect of a standardized supplementary pre-season multi-modal neurologic training program, versus usual training, on concussion and/or traumatic lower body injury severity (time loss from training/competition measured in days, determined from the date of injury to the date a sport medicine physician medically clears the athlete to return to unrestricted training/competition) (secondary prevention).
3. determine the effect of a standardized supplementary pre-season multi-modal neurologic training program, versus usual training, on neurologic performance.

The investigators hypothesize that athletes completing the standardized supplementary pre-season multi-modal neurologic training program, compared with usual training, will significantly reduce the participants risk and severity of concussion and/or traumatic lower body injury, and significantly improve neurologic performance.

Study Overview

• Status: Recruiting
• Conditions: Concussion, Brain; Traumatic Injury
• Intervention / Treatment: Behavioral: Pre-season supplementary neurologic training program

Detailed Description

This study will measure multiple neurological systems and brain processes on 400 Canadian high-performance snow sport athletes and elite community ice hockey players in the participants healthy (uninjured) state using reliable assessment technology and techniques. A two-month standardized, pre-season, supplementary multi-modal training program will be prescribed to 200 athletes (intervention cohort) by a team of experienced sport science and medicine professionals targeting the specific intrinsic risk factors of interest identified in the current concussion and ACL prevention literature. The control cohort of 200 athletes will carry out their usual pre-season training programs. At the completion of the two-month training period, the standardized neurological outcome measures completed at baseline will be repeated on all athletes.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian W. Benson, MD, PhD; Phone Number: 403-560-7579; Email: bbenson@csicalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Benson Concussion Institute
      • Contact: Brian W. Benson, MD, PhD; Phone Number: 403-560-7579; Email: bbenson@csicalgary.ca
      • Contact: Sean Dukelow, MD, PhD; Phone Number: 403-992-4986; Email: spdukelo@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. participation at the Canadian Senior National, National Development, Provincial, Sport School, Academy or Club levels of competition for skiing and snowboarding athletes, or participation in the Canadian Sport School Hockey League or Hockey Calgary U16 or first year U18 ice hockey levels of competition for hockey players between August 2021 and April 2023;
2. male or female;
3. assessed for a concussion or traumatic lower body injury that was sustained during an organized training session/practice or competition/game and diagnosis confirmed by a sport medicine physician; and
4. written informed consent to participate during the 2021-2022 and 2022-2023 seasons.

Exclusion Criteria:

1. previous history of neurological issues such as stroke, seizure, and/or congenital intracranial abnormalities, or non-fully resolved concussion or traumatic lower body injury sustained in the 3-month period prior to the initiation of study; and
2. non-sport-related concussions or traumatic lower body injuries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention cohort; Pre-season supplementary neurologic training program	Behavioral: Pre-season supplementary neurologic training program; A two-month standardized, pre-season, supplementary multi-modal training program will be prescribed to 200 athletes (intervention cohort) by a team of experienced sport science and medicine professionals targeting the specific intrinsic risk factors of interest identified in the current concussion and ACL prevention literature.
No Intervention: Control cohort; Usual pre-season training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sport-related concussion injuries sustained by participants during the study period as diagnosed by the study physician.	Sport-related concussion diagnosis will be based on clinical judgment by an experienced sport medicine physician based on participant self-report of post-traumatic clinical signs and symptoms, comprehensive neurological examination, and the Sport Concussion Assessment Tool (SCAT5).	Two years
Number of acute traumatic lower body injuries sustained by participants during the study period as diagnosed by the study physician.	Acute, traumatic lower body injury to the hip, thigh, knee, leg, ankle, foot including, but not limited to, fracture including avulsion fracture, labral tear, muscle contusion/tear, tendon strain/tear, ligament sprain/tear, meniscus tear, subluxation/dislocation, chondral injury or nerve injury diagnosed by study physician.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensorimotor function as measured by the Kinesiological Instrument for Normal and Altered Reaching Movements (Kinarm, Kingston, Ontario, Canada) end-point robotic standard tasks.	Kinarm Standard Tasks: 1) Visually Guided Reaching task examines visuomotor capability through parameters such as reaction time, movement speed, movement direction and smoothness. 2. Position Matching task examines proprioception through parameters such as absolute matching error and variability. 3. Object Hit task examines bimanual motor ability and visuospatial attention through parameters such as total hits, workspace use of each hand and movement speed. 4. Object Hit and Avoid task examines attention, rapid motor selection and inhibition through parameters such as distractor hits, workspace use of each hand and movement speed. 5. Trail Making B task examines attention and task-switching through parameters such as total test time and number of errors.	Mean change from baseline sensorimotor function on the Kinarm Standard Tasks at 8-weeks post pre-season training.
Neuromuscular function as measured by force plates and motion sensor.	Neuromuscular Assessments: 1) between-limb vertical jump force-time asymmetry testing, 2 hamstring/quadriceps rapid force production and maximal strength testing, 3) lower body power endurance, workload capacity and fatigue tolerance, 4) hip muscle strength and landing abilities, 5) quadriceps and hamstring rate of force development in the vertical countermovement jump, 6) clinical grade wearable sensor (PROTXX) attached to the participant's mastoid using a disposable medical adhesive directly measuring linear and rotational accelerations of the body.	Mean change from baseline neuromuscular function on the neuromuscular tasks and wearable sensor at 8-weeks post pre-season training.
Visual function as measured by the RightEye eye-tracking system.	RightEye is a Food and Drug Administration (FDA) approved healthcare technology designed to assess vision and associated brain health (i.e., fixation, eye teaming, object tracking, eye-hand coordination, reaction time).	Mean change from baseline visual function on the RightEye eye-tracking tasks at 8-weeks post pre-season training.
Cognitive function as measured by the computer-based Immediate Post-Concussion Assessment and Cognitive Test (ImPACT).	Measurement of memory, attention span, visual and verbal problem solving function using four composite scores (Verbal Memory Composite, Visual Memory Composite, Visual Motor Speed Composite, and Reaction Time)	Mean change from baseline cognitive function on the ImPACT neuropsychological composite scores at 8-weeks post pre-season training.
Dynamic neck strength as measured by the TopSpin360 neuromuscular neck-strengthening device.	The TopSpin360 device has an electronic counter that counts the number of revolutions and calculates the speed of the weight in revolutions per minute (RPM).	Mean change from baseline dynamic neck strength at 8-weeks post pre-season training.

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Brain Concussion
• Other Study ID Numbers: REB21-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No