NCT02389504

An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Concussion

Interventions

Type	Name	Description
OTHER	Dynamic Exertional Physical Therapy	By contrast, the dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) . Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase. Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.
OTHER	Standard Exertional Physical Therapy	Standard treadmill running, monitoring heart rate

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-01-20
• Completion: 2019-01-20
• First posted: 2015-03-17
• Last updated: 2019-01-16

Locations

1 site across 1 country: United States