Symptom Exacerbation and Adverse Events During a Randomized Trial of Early-Stage Rehabilitation After Sport-Related Concussion: Safety Outcomes From the Active Rehab Study
Bibliographic record
Abstract
CONTEXT: Authors of few studies have used randomized controlled trials (RCTs) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels. OBJECTIVE: Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions. DESIGN: Cluster RCT (NCT02988596). SETTING: Sports medicine clinic and field settings. PATIENTS OR OTHER PARTICIPANTS: The RCT enrolled 251 concussed athletes (median age = 20 years; female, n = 48) across 28 sites from New Zealand professional rugby (n = 31), Canadian professional football (n = 52), US/Canadian colleges (n = 128) and US high schools (n = 40). INTERVENTIONS: Two medically supervised interventions: (1) enhanced graded exertion (EGE): international return-to-sport strategy and sport-specific activities only (EGE only, n = 119); and (2) multidimensional rehabilitation (MDR) followed by EGE: early symptom-directed exercises once symptoms were stable, followed by EGE after symptoms resolved (MDR + EGE, n = 132). MAIN OUTCOME MEASURE(S): Primary outcomes were intrasession total symptom severity score exacerbation and significant intersession (increase 10+ severity points) sustained total symptom severity exacerbation, each measured with the Postconcussion Symptom Scale (132 total severity points on scale). Reported AEs were also described. Activity-based rehabilitation sessions (n = 1437) were the primary analysis unit. Frequencies, proportions, medians, and interquartile ranges were calculated for outcomes by treatment group. RESULTS: The 251 postinjury participants completed 1437 (MDR + EGE = 819, EGE only = 618) activity-based intervention sessions. A total of 110 and 105 participants contributed data (those missing had no documented session data) to at least 1 activity-based session in the MDR + EGE and EGE-only arms, respectively. Intrasession symptom exacerbations were equivalently low in MDR + EGE and EGE-only arms (MDR + EGE: 16.7%, 95% CI = 14.1%, 19.1%; EGE only: 15.7%, 95% CI = 12.8%, 18.6%). In total, 9/819 MDR + EGE sessions (0.9%) and 1/618 EGE-only sessions (0.2%) resulted in a presession to postsession symptom exacerbation beyond a 10+ severity point increase; 8/9 resolved to <10 points by the next session. Two study-related AEs (1 in each arm) were reported. CONCLUSIONS: Participants in MDR + EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".