Effect of Early Rest on Recovery From Pediatric Concussion

Mild Traumatic Brain Injury Clinical Trial

Official title:

Effect of Early Rest on Recovery From Pediatric Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101724
• Other study ID #: 5520163IRC
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: November 1, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 22 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Concussion
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-concussive Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive Outcomes	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	No
Secondary	Ancillary Neurocogntive Test Battery	Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days	10 days	No
Secondary	Parental Attitude to Concussion:	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	No