Effect of Early Rest on Recovery From Pediatric Concussion

Medical College of Wisconsin

Status: Completed

Conditions: Concussion; Mild Traumatic Brain Injury; Post-concussive Syndrome

Treatments: Behavioral: Mandated Rest, Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01101724

5520163IRC

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 11 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

Mandated Rest.

Treatment:

Behavioral: Mandated Rest, Intervention