Effect of Early Rest on Recovery From Pediatric Concussion

Not Applicable

Completed

• Conditions: Post-concussive Syndrome; Concussion; Mild Traumatic Brain Injury
• Interventions: Behavioral: Mandated Rest, Intervention

• Registration Number: NCT01101724
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Mandated Rest, Intervention	Mandated Rest.

Primary Outcome Measures

Name	Time	Method
Neurocognitive Outcomes	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

Name	Time	Method
Ancillary Neurocogntive Test Battery	10 days	Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
Parental Attitude to Concussion:	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.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States