Clinical trial NCT04992130: Sport Concussion Performance-Based Prevention Program
Official title: Sport-Related Concussion and Traumatic Lower Body Injury Performance-Based Prevention Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion, Brain
Traumatic Injury
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of sport-related concussion injuries sustained by participants during the study period as diagnosed by the study physician.
timeFrame: Two years
measure: Number of acute traumatic lower body injuries sustained by participants during the study period as diagnosed by the study physician.
timeFrame: Two years
Secondary outcomes:
measure: Sensorimotor function as measured by the Kinesiological Instrument for Normal and Altered Reaching Movements (Kinarm, Kingston, Ontario, Canada) end-point robotic standard tasks.
timeFrame: Mean change from baseline sensorimotor function on the Kinarm Standard Tasks at 8-weeks post pre-season training.
measure: Neuromuscular function as measured by force plates and motion sensor.
timeFrame: Mean change from baseline neuromuscular function on the neuromuscular tasks and wearable sensor at 8-weeks post pre-season training.
measure: Visual function as measured by the RightEye eye-tracking system.
timeFrame: Mean change from baseline visual function on the RightEye eye-tracking tasks at 8-weeks post pre-season training.
measure: Cognitive function as measured by the computer-based Immediate Post-Concussion Assessment and Cognitive Test (ImPACT).
timeFrame: Mean change from baseline cognitive function on the ImPACT neuropsychological composite scores at 8-weeks post pre-season training.
measure: Dynamic neck strength as measured by the TopSpin360 neuromuscular neck-strengthening device.
timeFrame: Mean change from baseline dynamic neck strength at 8-weeks post pre-season training.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Benson Concussion Institute
state: Alberta
Study officials:
References: