Concussion, BrainNCT04992130
Sport Concussion Performance-Based Prevention Program
A study testing Pre-season supplementary neurologic training program in people with Concussion, Brain and Traumatic Injury, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Traumatic Injury
- What is being tested?
- Pre-season supplementary neurologic training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2021to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Benson Concussion Institute
Calgary, Alberta
Brian W. Benson, MD, PhD, 403-560-7579, bbenson@csicalgary.ca
Sean Dukelow, MD, PhD, 403-992-4986, spdukelo@ucalgary.ca
About this study
Official title: 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:
Read more
- 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).
- 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).
- 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.
Read the 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
- Being tested
- Pre-season supplementary neurologic training program
- Medical subject headings
- Brain Concussion, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-season supplementary neurologic training programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Experimental | Pre-season supplementary neurologic training program Receives: Behavioral: Pre-season supplementary neurologic training program |
| Control cohort | No intervention | Usual pre-season training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Kinarm Standard Tasks:
- Visually Guided Reaching task examines visuomotor capability through parameters such as reaction time, movement speed, movement direction and smoothness.
- Position Matching task examines proprioception through parameters such as absolute matching error and variability.
- Object Hit task examines bimanual motor ability and visuospatial attention through parameters such as total hits, workspace use of each hand and movement speed.
- 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.
- Trail Making B task examines attention and task-switching through parameters such as total test time and number of errors.
Measured: 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:
- 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: Mean change from baseline dynamic neck strength at 8-weeks post pre-season training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start13 Sep 2021
- Primary completionApr 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Benson, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992130
- Sponsor's protocol ID
- REB21-1027
- Status last verified
- Sep 2021
- First submitted
- 20 Jul 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport-Related Concussion and Traumatic Lower Body Injury Performance-Based Prevention Program
- ClinicalTrials.gov ID
- NCT04992130
- Acronym / sponsor ID
- REB21-1027
- Conditions
- Concussion, Brain, Traumatic Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | Experimental | Behavioral: Pre-season supplementary neurologic training programPre-season supplementary neurologic training program |
| Control cohort | No intervention | –Usual pre-season training program |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-season supplementary neurologic training programA 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. | Behavioural | Intervention cohort |
Primary outcome
Number of sport-related concussion injuries sustained by participants during the study period as diagnosed by the study physician.
Time frame: Two years
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).
Number of acute traumatic lower body injuries sustained by participants during the study period as diagnosed by the study physician.
Time frame: Two years
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.
5 secondary outcomes
Sensorimotor function as measured by the Kinesiological Instrument for Normal and Altered Reaching Movements (Kinarm, Kingston, Ontario, Canada) end-point robotic standard tasks.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Mean change from baseline dynamic neck strength at 8-weeks post pre-season training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-season supplementary neurologic training program in people with Concussion, Brain and Traumatic Injury, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian W. Benson, MD, PhD (403-560-7579, bbenson@csicalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.