Concussion, Mild Traumatic Brain Injury, Post-concussive Syndrome
Conditions
Keywords
mild traumatic brain injury, Concussion, postconcussive syndrome
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.
Interventions
BEHAVIORALMandated 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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 22 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed