An interventional study of Neuromuscular training in Brain Concussion, Musculoskeletal Injury and Locomotion, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Neuromuscular training
Participants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.
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.
Injury rate
The number of injuries / the number of exposures to sports injury following return to play (RTP) after concussion
Time frame: One year
Physical activity level
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.
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.
Dual-task walking speed.
Measure of the the average walking speed of subjects during dual-task conditions (m/s).
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.
Reaction time
We will use smartphone-based reaction time assessments (ms)
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.
Post Concussion Symptom Inventory
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.
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.
PROMIS Short Form Pediatric 25
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.
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.
Tampa Scale of Kinesiophobia
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.
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.
Tandem gait
A brief assessment of gait performance included in the SCAT5. The outcome measure is time to complete the test.
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.
Compliance with NMT 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.
Time frame: Week 1, 2, 3, 4, 5, 6, 7, and 8 of the NMT training program.
Plan to share: No
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University of Colorado, Denver