NCT01101724

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

1.7 years

First QC Date

April 8, 2010

Last Update Submit

November 1, 2013

Conditions

Mild Traumatic Brain InjuryConcussionPost-concussive Syndrome

Keywords

mild traumatic brain injuryConcussionpostconcussive syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Ancillary Neurocogntive Test Battery

    10 days

  • Parental Attitude to Concussion:

    10 days

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Mandated Rest.

Behavioral: Mandated Rest, Intervention

Interventions

Mandated Rest, InterventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age11 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years
  • present to the Emergency Department within 24 hours of a head injury

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53045, United States

Location

Related Publications (3)

  • Sufrinko AM, Kontos AP, Apps JN, McCrea M, Hickey RW, Collins MW, Thomas DG. The Effectiveness of Prescribed Rest Depends on Initial Presentation After Concussion. J Pediatr. 2017 Jun;185:167-172. doi: 10.1016/j.jpeds.2017.02.072. Epub 2017 Mar 29.

    PMID: 28365025DERIVED

  • Silverberg ND, Iverson GL, McCrea M, Apps JN, Hammeke TA, Thomas DG. Activity-Related Symptom Exacerbations After Pediatric Concussion. JAMA Pediatr. 2016 Oct 1;170(10):946-953. doi: 10.1001/jamapediatrics.2016.1187.

    PMID: 27479847DERIVED

  • 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.

    PMID: 25560444DERIVED

MeSH Terms

Conditions

Brain ConcussionPost-Concussion Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Danny G Thomas, MD, MPH

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(1)