An interventional study of Mandated Rest, Intervention in Mild Traumatic Brain Injury, Concussion and Post-concussive Syndrome, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 11 Years to 22 Years. Per ClinicalTrials.gov, last updated 2013-11-05.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 99 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
Time frame: 10 days post injury
Ancillary Neurocogntive Test Battery
Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
Time frame: 10 days
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.
Time frame: 10 days
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin