A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2019
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 9, 2022
May 1, 2022
3 years
April 4, 2019
May 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Injury rate
The number of injuries / the number of exposures to sports injury following return to play (RTP) after concussion
One year
Secondary Outcomes (7)
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.
- +2 more secondary outcomes
Other Outcomes (1)
Compliance with NMT program
Week 1, 2, 3, 4, 5, 6, 7, and 8 of the NMT training program.
Study Arms (2)
Intervention
EXPERIMENTALUpon 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.
Usual Care
NO INTERVENTIONParticipants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.
Interventions
Training will be conducted with a research assistant under the supervision of Dr. Howell (PI), a certified athletic trainer, who will meet with participants either at the individual or small group level (3-4 participants maximum). Training will be done within the Children's Hospital Colorado network-of-care locations, dependent on the location of participants. Due to in-person restrictions that have resulted from COVID-19, participants may also complete the intervention via remote (virtual) training sessions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Related Publications (2)
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.
PMID: 35060759BACKGROUNDHowell 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.
PMID: 34482050BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Howell, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 17, 2019
Study Start
April 2, 2019
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share