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A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

Primary Purpose

Brain Concussion, Musculoskeletal Injury, Locomotion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm 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.

Participants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Dual-task walking speed.
Measure of the the average walking speed of subjects during dual-task conditions (m/s).
Reaction time
We will use smartphone-based reaction time assessments (ms)
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.
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.
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.
Tandem gait
A brief assessment of gait performance included in the SCAT5. The outcome measure is time to complete the test.

Full Information

First Posted
April 4, 2019
Last Updated
May 3, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03917290
Brief Title
A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
Official Title
A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Musculoskeletal Injury, Locomotion, Postural Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants cleared to RTP in the usual care arm will return to sports and not undergo any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Injury rate
Description
The number of injuries / the number of exposures to sports injury following return to play (RTP) after concussion
Time Frame
One year
Secondary Outcome Measure Information:
Title
Physical activity level
Description
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.
Title
Dual-task walking speed.
Description
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.
Title
Reaction time
Description
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.
Title
Post Concussion Symptom Inventory
Description
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.
Title
PROMIS Short Form Pediatric 25
Description
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.
Title
Tampa Scale of Kinesiophobia
Description
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.
Title
Tandem gait
Description
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.
Other Pre-specified Outcome Measures:
Title
Compliance with NMT program
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Howell, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35060759
Citation
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.
Results Reference
background
PubMed Identifier
34482050
Citation
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.
Results Reference
background

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A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

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