Clinical trial · Interventional
Concussion Active Rehabilitation
Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
NCT04248218CI-TRIAL-00060592completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Concussion, Brain | — | UNRESOLVED | — |
| Concussion, Intermediate | — | UNRESOLVED | — |
| Concussion, Mild | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Rehabilitation Group/Case | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Normal/Control
- description
- Control Group/Standard Care
- type
- ACTIVE_COMPARATOR
- label
- Active Rehabilitation Group/Case
- description
- Active Rehabilitation Cohort/Intervention
- interventionNames
- Behavioral: Active Rehabilitation Group/Case
Primary outcomes (1)
- measure
- We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion.
- timeFrame
- 28 to 32 days post Emergency Department
- description
- We hypothesize that subjects managed with active rehabilitation post an acute concussion will have a 20% decreased relative risk of PCS compared to those managed with standard care.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient diagnosed with an acute concussion within 48 hours * Patient greater than 8 and less than 19 years old Exclusion Criteria: * Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD) * Cognitive delay * GCS \< 14 * positive findings on head CT * Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
References
Publications (0)
Data not yet available
No reference posted for this study.