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Effect of Early Rest on Recovery From Pediatric Concussion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Danny Thomas, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01101724
First received: April 8, 2010
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Mild Traumatic Brain Injury
Concussion
Post-concussive Syndrome
 Behavioral: Mandated Rest, Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Rest on Recovery From Pediatric Concussion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 110
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 22 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Danny Thomas, Assistant Professor of Pediatrics, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01101724     History of Changes
Other Study ID Numbers: 5520163IRC
Study First Received: April 8, 2010
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 13, 2013