Evidence map›Paper›PMID 38775119›Full record

Trial reportJournal of athletic training2024

Symptom Exacerbation and Adverse Events During a Randomized Trial of Early-Stage Rehabilitation After Sport-Related Concussion: Safety Outcomes From the Active Rehab Study.

Johna K Register-Mihalik, Kevin M Guskiewicz, Stephen W Marshall, Karen L McCulloch, Jason P Mihalik, Martin Mrazik, Ian Murphy, Dhiren Naidu, Shabbar I Ranapurwala, Kathryn J Schneider and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of athletic training, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02988596 (Management and Treatment of Sport-related Concussion), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02988596 nacompletednot on this map

Management and Treatment of Sport-related Concussion: Early Multidimensional Rehabilitation Versus Enhanced Graded Exercise

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2017 to 2019Enrolled251ConditionsConcussion, BrainArmsMultidimensional Active Rehabilitation, Enhanced Graded Exertion
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Johna K Register-MihalikMatthew Gfeller Center, Department of Exercise and Sport Science.
Kevin M GuskiewiczMatthew Gfeller Center, Department of Exercise and Sport Science.
Stephen W MarshallMatthew Gfeller Center, Department of Exercise and Sport Science.
Karen L McCullochDivision of Physical Therapy, Department of Health Sciences, School of Medicine, University of North Carolina at Chapel Hill.
Jason P MihalikMatthew Gfeller Center, Department of Exercise and Sport Science.
Martin MrazikFaculties of Education, University of Alberta, Edmonton, Canada.
Ian MurphyInjury Prevention and Player Welfare, New Zealand Rugby, Wellington.
Dhiren NaiduMedicine & Dentistry, University of Alberta, Edmonton, Canada.
Shabbar I RanapurwalaInjury Prevention Research Center.
Kathryn J SchneiderSport Injury Prevention Research Centre, Faculty of Kinesiology, Alberta Children's Hospital Research Institute, Hotchkiss Brain Institute, University of Calgary, Canada.
Paula GildnerInjury Prevention Research Center.
Danielle M SalmonInjury Prevention and Player Welfare, New Zealand Rugby, Wellington.
Brandon AutonCatawba College, Salisbury, NC.
Thomas G BowmanCollege of Health Sciences, University of Lynchburg, VA.
Eric E HallDepartment of Exercise Science, Elon University, NC.
Loriann M HynesSchool of Kinesiology & Health Science, York University, Toronto, ON, Canada.
Elizabeth JewellDepartment of Kinesiology and Recreation Administration, North Carolina Central University, Durham.
Caroline J KetchamDepartment of Exercise Science, Elon University, NC.
Caroline Wesley SilerCollege of Health Sciences, University of Lynchburg, VA.
S John SullivanInjury Prevention and Player Welfare, New Zealand Rugby, Wellington.
Vasiliki KostogiannesInjury Prevention Research Center.
Michael A McCreaCenter for Neurotrauma Research, Department of Neurosurgery, Medical College of Wisconsin, Milwaukee.
Active Rehab Study Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextAuthors of few studies have used randomized controlled trials (RCTs) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels.

objectiveDescribe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions.

designCluster RCT (NCT02988596).

settingSports medicine clinic and field settings. PATIENTS OR OTHER

participantsThe 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).

interventionsTwo 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.

resultsThe 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.

conclusionsParticipants in MDR + EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.

Indexed as

Athletic InjuriesBrain ConcussionReturn to SportAdolescentAdultAthletesCanadaExercise TherapyFemaleFootballHumansMaleNew ZealandPost-Concussion SyndromeYoung Adultearly activityreturn to sporttraumatic brain injury

Identifiers

PMID38775119
PMCPMC11684750

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.