Effect of Early Rest on Recovery From Pediatric Concussion - Full Text View

Purpose

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

Condition	Intervention
Mild Traumatic Brain Injury Concussion Post-concussive Syndrome	Behavioral: Mandated Rest, Intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Effect of Early Rest on Recovery From Pediatric Concussion

Resource links provided by NLM:

MedlinePlus related topics: Concussion Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Neurocognitive Outcomes [ Time Frame: 10 days post injury ] [ Designated as safety issue: No ]
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:

Ancillary Neurocogntive Test Battery [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
Parental Attitude to Concussion: [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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.


Enrollment:	99
Study Start Date:	April 2010
Study Completion Date:	December 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Standard of Care 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.
Experimental: Intervention 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.

Arms

Assigned Interventions

No Intervention: Standard of Care

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.

Experimental: Intervention

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.

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.

Eligibility


Ages Eligible for Study:	11 Years to 22 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101724

Locations


United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53045

Sponsors and Collaborators

Medical College of Wisconsin

Investigators


Principal Investigator:	Danny G Thomas, MD, MPH	Medical College of Wisconsin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.


Responsible Party:	Danny Thomas, Assistant Professor of Pediatrics, Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT01101724 History of Changes
Other Study ID Numbers:	5520163IRC
Study First Received:	April 8, 2010
Last Updated:	November 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:


mild traumatic brain injury Concussion postconcussive syndrome

Additional relevant MeSH terms:


Brain Injuries Brain Concussion Post-Concussion Syndrome Brain Diseases Central Nervous System Diseases Nervous System Diseases	Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Head Injuries, Closed Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 29, 2016