Recruiting

Concussion Program

Sponsor:

University of Calgary

Code:

NCT04992130

Conditions

Concussion, Brain

Traumatic Injury

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

Pre-season supplementary neurologic training program

Study Details

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.

Conditions

Concussion, Brain

Traumatic Injury

Study ID

NCT04992130

Start date

Sep 13, 2021

Status verified date

Sep, 2021

Completion date

Aug, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention cohort

Pre-season supplementary neurologic training program

no intervention: Control cohort

Usual pre-season training program

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.

Primary outcome measure

  • Number of sport-related concussion injuries sustained by participants during the study period as diagnosed by the study physician. [ Time Frame: Two years ]
  • Number of acute traumatic lower body injuries sustained by participants during the study period as diagnosed by the study physician. [ Time Frame: Two years ]

Central Contacts and Locations

Central contacts

Brian W. Benson, MD, PhD

403-560-7579bbenson@csicalgary.ca

Locations

Benson Concussion Institute

Recruiting

Calgary, Alberta, Canada

Contacts

Brian W. Benson, MD, PhD

403-560-7579bbenson@csicalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Sep 20, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-09-20.