Sport Concussion Performance-Based Prevention Program

NCT04992130 | Unknown

• 1 other identifier: REB21-1027
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.determine the effect of a standardized supplementary pre-season multi-modal neurologic training program, versus usual training, on neurologic performance.

Conditions

Concussion, Brain; Traumatic Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Sensorimotor function as measured by the Kinesiological Instrument for Normal and Altered Reaching Movements (Kinarm, Kingston, Ontario, Canada) end-point robotic standard tasks.

  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.

  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.

  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).

  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.

  Mean change from baseline dynamic neck strength at 8-weeks post pre-season training.

Study Arms (2)

Intervention cohort

EXPERIMENTAL

Pre-season supplementary neurologic training program

Behavioral: Pre-season supplementary neurologic training program

Control cohort

NO INTERVENTION

Usual pre-season training program

Interventions

Pre-season supplementary neurologic training program 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.

Intervention cohort

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• male or female;
• 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
• written informed consent to participate during the 2021-2022 and 2022-2023 seasons.

You may not qualify if:

• 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
• non-sport-related concussions or traumatic lower body injuries.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Benson Concussion Institute

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating

Central Study Contacts

Brian W. Benson, MD, PhD

CONTACT

403-560-7579; bbenson@csicalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 5, 2021
• Study Start: September 13, 2021
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)