Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917290
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
Injury rate [ Time Frame: One year ]
The number of injuries / the number of exposures to sports injury following return to play (RTP) after concussion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Physical activity level [ Time Frame: <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. ]
    In order to assess the effect of physical activity level on incidence and timing of subsequent musculoskeletal (MSK) injuries, we will provide participants with heart-rate activity monitors, worn from the initial post-concussion visit until RTP.
  • Dual-task walking speed. [ Time Frame: <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 of the the average walking speed of subjects during dual-task conditions (m/s).
  • Reaction time [ Time Frame: <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. ]
    We will use smartphone-based reaction time assessments (ms)
  • Post Concussion Symptom Inventory [ Time Frame: <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. ]
    Overall symptom severity, rated as a sum score from 0-122. A higher score indicates more severe symptoms, while a 0 indicates that the patient is not experiencing symptoms.
  • PROMIS Short Form Pediatric 25 [ Time Frame: <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. ]
    A brief generalized quality of life questionnaire. We will calculate the sub-scale scores for the domains of Mobility, Depressive Symptoms, Anxiety, Peer Relationships, and Pain Interference. Each sub-scale is calculated as a sum of 4 questions, rated from 0-4. Thus, each subscale is from 0-16, where a 16 indicates a greater presence of the domain being measured.
  • Tampa Scale of Kinesiophobia [ Time Frame: <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. ]
    A brief questionnaire about fear of movement and injury related to returning to sport. The subject answers 18 questions rated from 1 (strongly disagree) to 4 (strongly agree). There is a total sum score ranging form 18-72, where a higher score represents more fear of movement.
  • Tandem gait [ Time Frame: <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. ]
    A brief assessment of gait performance included in the SCAT5. The outcome measure is time to complete the test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2019)
Compliance with NMT program [ Time Frame: Week 1, 2, 3, 4, 5, 6, 7, and 8 of the NMT training program. ]
The athletic trainer administering the protocol will record patient compliance for all treatment sessions. Each session is rated as yes/no by the supervising athletic trainer, and a total percentage of all training sessions is calculated as the compliance score.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
Official Title  ICMJE A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Concussion
  • Musculoskeletal Injury
  • Locomotion
  • Postural Balance
Intervention  ICMJE Behavioral: Neuromuscular training
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.
Study Arms  ICMJE
  • Experimental: Intervention
    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.
    Intervention: Behavioral: Neuromuscular training
  • No Intervention: Usual Care
    Participants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David R Howell, PhD 7207771502 david.howell@ucdenver.edu
Contact: Morgan Potter, BA 720 morgan.potter@childrenscolorado.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917290
Other Study ID Numbers  ICMJE 18-2680
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R Howell, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP