Effect of Early Rest on Recovery From Pediatric Concussion

November 1, 2013 updated by: Danny Thomas, Medical College of Wisconsin
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53045
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary Neurocogntive Test Battery
Time Frame: 10 days
Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
10 days
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Danny G Thomas, MD, MPH, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5520163IRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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