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A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Locomotion
Postural Balance
Musculoskeletal Injury
Brain Concussion

Treatments

Behavioral: Neuromuscular training

Study type

Interventional

Funder types

Other

Identifiers

NCT03917290
18-2680

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Intervention
Experimental group
Description:
Upon clearance to RTP after concussion, participants randomized to NMT will complete training for 20-30 minutes, two times per week, beginning at RTP and continuing at this frequency for 8 weeks.
Treatment:
Behavioral: Neuromuscular training
Usual Care
No Intervention group
Description:
Participants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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