Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial.

OBJECTIVES

To examine the safety and tolerability of an active rehabilitation program for adolescents who are slow to recover from a sport-related concussion, and secondarily to estimate the treatment effect for this intervention.

DESIGN

Single-site, parallel, open-label, randomized controlled trial comparing treatment as usual (TAU) to TAU plus active rehabilitation.

SETTING

Outpatient concussion clinic.

PARTICIPANTS

Adolescents (N=19) aged 12 to 18 years with postconcussion symptoms lasting ≥1 month after a sports-related concussion.

INTERVENTIONS

TAU consisted of symptom management and return-to-play advice, return-to-school facilitation, and physiatry consultation. The active rehabilitation program involved in-clinic subsymptom threshold aerobic training, coordination exercises, and visualization and imagery techniques with a physiotherapist (mean, 3.4 sessions) as well as a home exercise program, over 6 weeks.

MAIN OUTCOME MEASURES

A blinded assessor systematically monitored for predetermined adverse events in weekly telephone calls over the 6-week intervention period. The treating physiotherapist also recorded in-clinic symptom exacerbations during aerobic training. The Post-Concussion Symptom Scale was the primary efficacy outcome.

RESULTS

Nineteen participants were randomized, and none dropped out of the study. Of the 12 adverse events detected (6 in each group), 10 were symptom exacerbations from 1 weekly telephone assessment to the next, and 2 were emergency department visits. Four adverse events were referred to an external safety committee and deemed unrelated to the study procedures. In-clinic symptom exacerbations occurred in 30% (9/30) of aerobic training sessions, but resolved within 24 hours in all instances. In linear mixed modeling, active rehabilitation was associated with a greater reduction on the Post-Concussion Symptom Scale than TAU only.

CONCLUSIONS

The results support the safety, tolerability, and potential efficacy of active rehabilitation for adolescents with persistent postconcussion symptoms.