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Clinical Trials/NCT03917290
NCT03917290
Completed
N/A

A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

University of Colorado, Denver1 site in 1 country40 target enrollmentApril 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Concussion
Sponsor
University of Colorado, Denver
Enrollment
40
Locations
1
Primary Endpoint
Injury rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2019
End Date
April 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Injury rate

Time Frame: One year

The number of injuries / the number of exposures to sports injury following return to play (RTP) after concussion

Secondary Outcomes

  • Physical activity level(<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.)
  • Dual-task walking speed.(<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.)
  • Reaction time(<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.)
  • Post Concussion Symptom Inventory(<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.)
  • PROMIS Short Form Pediatric 25(<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.)
  • Tampa Scale of Kinesiophobia(<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.)
  • Tandem gait(<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.)

Study Sites (1)

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