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Brain ConcussionNCT03917290

A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

A study testing Neuromuscular training in people with Brain Concussion and Musculoskeletal Injury, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Neuromuscular training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
2 Apr 2019to 1 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the detailed description

Aims:

  1. 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.

Being tested
Neuromuscular training
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular trainingBehavioural

    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.

Study groups in NCT03917290
Study groupRoleWhat they receive
InterventionExperimentalUpon 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.
Receives: Behavioral: Neuromuscular training
Usual CareNo interventionParticipants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Injury rate

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

    Measured: One year

Secondary outcomes (7)

  1. 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.

    Measured: <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. Dual-task walking speed.

    Measure of the the average walking speed of subjects during dual-task conditions (m/s).

    Measured: <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.

  3. Reaction time

    We will use smartphone-based reaction time assessments (ms)

    Measured: <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.

  4. 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.

    Measured: <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.

  5. 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.

    Measured: <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.

  6. 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.

    Measured: <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.

  7. Tandem gait

    A brief assessment of gait performance included in the SCAT5. The outcome measure is time to complete the test.

    Measured: <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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start2 Apr 2019
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917290
Sponsor's protocol ID
18-2680
Status last verified
May 2022
First submitted
4 Apr 2019
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35060759

  • Howell 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.

    PubMed 34482050

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular training in people with Brain Concussion and Musculoskeletal Injury, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Injury rate (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03917290, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.

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