Back to resultsEffect of Early Rest on Recovery From Pediatric Concussion
Primary Purpose
Mild Traumatic Brain Injury, Concussion, Post-concussive Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mandated Rest, Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring mild traumatic brain injury, Concussion, postconcussive syndrome
Eligibility Criteria
Inclusion Criteria:
- 11-22 years
- present to the Emergency Department within 24 hours of a head injury
Exclusion Criteria:
- patients who are being admitted,
- non-English speaking patient/family,
- mental retardation (IQ < 70)
- Suspected intoxication
- restricted used of dominant hand or limited vision
- injury or conditions affecting balance assessment
- prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy)
- known intracranial injury (e.g., intracranial bleeding, cerebral contusion)
- patients for whom a legal guardian is not present or cannot be contacted.
- ED clinician preference
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Intervention
Arm Description
In this group, the treating attending physician will be free to make rest recommendations as they see fit. An internal survey of physician practice found that the vast majority of physicians instruct patients rest for 1-2 days, then to return to school and physical activity after the patient's symptoms have resolved. The amount of rest will vary from patients to patient based on variation in symptom resolution and patient compliance. This advice is consistent with best practices outlined by the CDC.
Mandated Rest.
Outcomes
Primary Outcome Measures
Neurocognitive Outcomes
Neurocogntive outcomes assessed using computer-based neurocogntive testing based on changes from scores obtained in the emergency department to scores obtained at 3 days and 10 days.
Secondary Outcome Measures
Ancillary Neurocogntive Test Battery
Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
Parental Attitude to Concussion:
Assess potential barriers to compliance, we will assess parental attitudes toward concussion by administering a survey to parents or caregivers during the ten day home visit.
Full Information
NCT ID
NCT01101724
First Posted
April 8, 2010
Last Updated
November 1, 2013
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT01101724
Brief Title
Effect of Early Rest on Recovery From Pediatric Concussion
Official Title
Effect of Early Rest on Recovery From Pediatric Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
Detailed Description
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion. This research is being done because, currently, there is no effective treatment for concussion. Physical activity (for example; running, playing sports) and brain activity (for example; homework and tests) may make concussion symptoms worse. We are studying whether strict rest after concussion may help improve symptoms. About 110 children, ages 11-22 years old will take part in this study at the Children's Hospital of Wisconsin. This study is being funded by the Injury Research Center. The research grant pays for study procedures, follow-up testing, and patient reimbursement. Research staff is not being provided incentives to enroll subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Concussion, Post-concussive Syndrome
Keywords
mild traumatic brain injury, Concussion, postconcussive syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
In this group, the treating attending physician will be free to make rest recommendations as they see fit. An internal survey of physician practice found that the vast majority of physicians instruct patients rest for 1-2 days, then to return to school and physical activity after the patient's symptoms have resolved. The amount of rest will vary from patients to patient based on variation in symptom resolution and patient compliance. This advice is consistent with best practices outlined by the CDC.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Mandated Rest.
Intervention Type
Behavioral
Intervention Name(s)
Mandated Rest, Intervention
Intervention Description
In addition to CDC based discharge instructions, the intervention group will receive instructions with strict activity restriction explicitly stating "No return to school" and "No Physical Activity" for the next five days. Patients and parents in the intervention group will be provided school and work excuses for the five days post-injury.
Primary Outcome Measure Information:
Title
Neurocognitive Outcomes
Description
Neurocogntive outcomes assessed using computer-based neurocogntive testing based on changes from scores obtained in the emergency department to scores obtained at 3 days and 10 days.
Time Frame
10 days post injury
Secondary Outcome Measure Information:
Title
Ancillary Neurocogntive Test Battery
Description
Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
Time Frame
10 days
Title
Parental Attitude to Concussion:
Description
Assess potential barriers to compliance, we will assess parental attitudes toward concussion by administering a survey to parents or caregivers during the ten day home visit.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
11-22 years
present to the Emergency Department within 24 hours of a head injury
Exclusion Criteria:
patients who are being admitted,
non-English speaking patient/family,
mental retardation (IQ < 70)
Suspected intoxication
restricted used of dominant hand or limited vision
injury or conditions affecting balance assessment
prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy)
known intracranial injury (e.g., intracranial bleeding, cerebral contusion)
patients for whom a legal guardian is not present or cannot be contacted.
ED clinician preference
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny G Thomas, MD, MPH
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53045
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28365025
Citation
Sufrinko AM, Kontos AP, Apps JN, McCrea M, Hickey RW, Collins MW, Thomas DG. The Effectiveness of Prescribed Rest Depends on Initial Presentation After Concussion. J Pediatr. 2017 Jun;185:167-172. doi: 10.1016/j.jpeds.2017.02.072. Epub 2017 Mar 29.
Results Reference
derived
PubMed Identifier
27479847
Citation
Silverberg ND, Iverson GL, McCrea M, Apps JN, Hammeke TA, Thomas DG. Activity-Related Symptom Exacerbations After Pediatric Concussion. JAMA Pediatr. 2016 Oct 1;170(10):946-953. doi: 10.1001/jamapediatrics.2016.1187.
Results Reference
derived
PubMed Identifier
25560444
Citation
Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.
Results Reference
derived
Learn more about this trial
Effect of Early Rest on Recovery From Pediatric Concussion
We'll reach out to this number within 24 hrs