Effect of Early Rest on Recovery From Pediatric Concussion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danny Thomas, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01101724
First received: April 8, 2010
Last updated: November 1, 2013
Last verified: November 2013

April 8, 2010
November 1, 2013
April 2010
December 2011   (final data collection date for primary outcome measure)
Neurocognitive Outcomes [ Time Frame: 10 days post injury ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01101724 on ClinicalTrials.gov Archive Site
  • Ancillary Neurocogntive Test Battery [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
  • Parental Attitude to Concussion: [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effect of Early Rest on Recovery From Pediatric Concussion
Effect of Early Rest on Recovery From Pediatric Concussion

The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Mild Traumatic Brain Injury
  • Concussion
  • Post-concussive Syndrome
Behavioral: Mandated Rest, Intervention
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.
  • No Intervention: Standard of Care
    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.
  • Experimental: Intervention
    Mandated Rest.
    Intervention: Behavioral: Mandated Rest, Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
11 Years to 22 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01101724
5520163IRC
Yes
Danny Thomas, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Danny G Thomas, MD, MPH Medical College of Wisconsin
Medical College of Wisconsin
November 2013

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