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Effect of Early Rest on Recovery From Pediatric Concussion

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ClinicalTrials.gov Identifier: NCT01101724
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Danny Thomas, Medical College of Wisconsin

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

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Concussion Post-concussive Syndrome Behavioral: Mandated Rest, Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Rest on Recovery From Pediatric Concussion
Study Start Date : April 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive Outcomes [ Time Frame: 10 days post injury ]
    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 :
  1. Ancillary Neurocogntive Test Battery [ Time Frame: 10 days ]
    Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days

  2. Parental Attitude to Concussion: [ Time Frame: 10 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101724


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53045
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Danny G Thomas, MD, MPH Medical College of Wisconsin
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Danny Thomas, Assistant Professor of Pediatrics, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01101724     History of Changes
Other Study ID Numbers: 5520163IRC
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Danny Thomas, Medical College of Wisconsin:
mild traumatic brain injury
Concussion
postconcussive syndrome

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating