Clinical trial NCT03917290: A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
Official title: A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Musculoskeletal Injury
Locomotion
Postural Balance
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon clearance to Return to Play (RTP) after concussion, all participants will be randomized to either a Neuromuscular training (NMT) group or usual care (no sports injury prevention training). Those in the NMT group will complete training for 20-30 minutes, two times per week, beginning at RTP and continuing at this frequency until the end of the current athletic season.
Primary purpose: TREATMENT

Brief summary: The long-term goal of this research is to implement methods that healthcare providers can use across diverse clinical settings to (1) identify athletes at risk for (musculoskeletal) MSK injury when cleared to return to play (RTP) after a concussion and (2) develop practical ways to reduce MSK injury risk following concussion RTP. The rationale is that once post-concussion MSK injury risk factors are known and prevention strategies tested, concussion RTP protocols will evolve to include injury risk reduction programs.

Detailed description: Aims:

i. To determine the effect of a sports injury prevention program on MSK injuries initiated at concussion RTP and continued throughout the subsequent athletic season.

ii. To examine the effect of a neuromuscular training (NMT) program on clinical and instrumented postural control measures before and after the intervention.

The proposed study will use an intervention-based paradigm to further understand MSK injury risk after concussion RTP and to identify potential methods to reduce this risk. Common Data Element (CDE) and instrumented postural control data will be linked to objectively classify the clinical and functional underpinnings of concussion recovery and subsequent MSK injury among those engaged in an injury prevention program compared to those who are not. These are important elements to investigate because: 1) few studies have explored the mechanisms for MSK injury incidence after concussion using a multimodal and objective approach and 2) no investigations have examined interventions to improve long-term concussion outcomes initiated at RTP.

Eligibility criteria: Inclusion Criteria:

* Eligible participants will be those diagnosed with a concussion, defined as a brain injury caused by a direct blow to the head, face, neck or elsewhere on the body, resulting in the rapid onset of impairment of neurological function and diagnosed by Children's Hospital Colorado sports medicine physicians.
* Being between 12-18 years of age
* The ability to complete initial testing within 14 days of the injury
* A post-concussion symptom scale (PCSS) score of greater than 9 at the time of enrollment.

Exclusion Criteria:

* Active lower extremity injury affecting balance
* Pre-existing neurological disorder (bipolar disorder, schizophrenia, etc.)
* Previous concussion sustained within the past year
* Prisoners, pregnant females, individuals with limited decision-making capacity
* Pre-existing learning disability
* Structural brain injury (confirmed with neuroimaging)
* A high velocity injury mechanism (e.g motor vehicle accident).
* Less than one month remaining in the current athletic season.

Primary outcomes:
measure: Injury rate
timeFrame: One year
Secondary outcomes:
measure: Physical activity level
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
measure: Dual-task walking speed.
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for return to play (RTP), and 8 weeks after the treating physician clear the subject for RTP.
measure: Reaction time
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
measure: Post Concussion Symptom Inventory
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
measure: PROMIS Short Form Pediatric 25
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
measure: Tampa Scale of Kinesiophobia
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
measure: Tandem gait
timeFrame: <14 days post-concussion, and once the treating physician clears the subject for RTP, and 8 weeks after the treating physician clear the subject for RTP.
Other outcomes:
measure: Compliance with NMT program
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, and 8 of the NMT training program.
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David R Howell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howell DR, Seehusen CN, Carry PM, Walker GA, Reinking SE, Wilson JC. An 8-Week Neuromuscular Training Program After Concussion Reduces 1-Year Subsequent Injury Risk: A Randomized Clinical Trial. Am J Sports Med. 2022 Mar;50(4):1120-1129. doi: 10.1177/03635465211069372. Epub 2022 Jan 21.
citation: Howell DR, Seehusen CN, Walker GA, Reinking S, Wilson JC. Neuromuscular training after concussion to improve motor and psychosocial outcomes: A feasibility trial. Phys Ther Sport. 2021 Nov;52:132-139. doi: 10.1016/j.ptsp.2021.05.014. Epub 2021 Aug 28.