Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02389504
Brief Summary:
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
Detailed Description:
Written informed parental consent and assent will be obtained for all subjects. The PI or Co-I will administer ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), the PCSS (Post Concussion Symptom Scale), and the VOMS (Vestibular Ocular Motor Screening) to each subject during their first clinical visit. In addition to demographic variables such as age and gender, groups will be matched based on ImPACT and VOMS performance as well as the number, type, and severity of symptoms reported on the PCSS. Subjects will be assigned to receive either the currently accepted standard of care (Heart Rate Exertion group) or the newly developed exertion protocol (Dynamic Exertion Group). Participants will be matched according to PCSS total, VOMS symptom report, and by demographic variables including age and gender. The first participant will be assigned to the dynamic exertion group and the next to the standard of care group, alternating accordingly as covariates allow. The physical therapists will be responsible for administering the assigned exertion protocol to each subject across four time points (one week between each session). Follow-up data regarding recovery time (i.e., clinical return to normal activity) will also be collected. Neurocognitive testing will take place on 3-4 week intervals as is consistent with clinical practice. The current study will include a pre-exertion neurocognitive evaluation and a post-exertion protocol neurocognitive evaluation.
Study:
NCT02389504
Study Brief:
Protocol Section:
NCT02389504