Sport Concussion Performance-Based Prevention Program

NCT ID: NCT04992130

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2023-08-31

Brief Summary

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.

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.

Conditions

Concussion, Brain; Traumatic Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention cohort

Pre-season supplementary neurologic training program

Group Type: EXPERIMENTAL

Pre-season supplementary neurologic training program

Intervention Type: BEHAVIORAL

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.

Control cohort

Usual pre-season training program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Brian Benson

Assistant Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benson Concussion Institute

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Brian W. Benson, MD, PhD

Role: CONTACT

bbenson@csicalgary.ca

403-560-7579

Facility Contacts

Brian W. Benson, MD, PhD

Role: primary

bbenson@csicalgary.ca

403-560-7579

Sean Dukelow, MD, PhD

Role: backup

spdukelo@ucalgary.ca

403-992-4986

Other Identifiers

REB21-1027

Identifier Type: -

Identifier Source: org_study_id