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Effect of Early Rest on Recovery From Pediatric Concussion

This study has been completed.
Information provided by (Responsible Party):
Danny Thomas, Medical College of Wisconsin Identifier:
First received: April 8, 2010
Last updated: November 1, 2013
Last verified: November 2013
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 (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Rest on Recovery From Pediatric Concussion

Further study details as provided by Danny Thomas, Medical College of Wisconsin:

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

Enrollment: 99
Study Start Date: April 2010
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.

Ages Eligible for Study:   11 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01101724

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53045
Sponsors and Collaborators
Medical College of Wisconsin
Principal Investigator: Danny G Thomas, MD, MPH Medical College of Wisconsin
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Danny Thomas, Assistant Professor of Pediatrics, Medical College of Wisconsin Identifier: NCT01101724     History of Changes
Other Study ID Numbers: 5520163IRC
Study First Received: April 8, 2010
Last Updated: November 1, 2013

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

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
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 processed this record on September 19, 2017