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OpenTrials
Completed

NCT Number: NCT01101724

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.

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Key information

Age range

11 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandated Rest, Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 12, 2010
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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