An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Not Applicable

Withdrawn

• Conditions: Concussion

• Registration Number: NCT02389504
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Study Start: 2016-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16
• Primary Completion: 2019-01-20
• Study Completion: 2019-01-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 14-17 years of age
• Referred to exertion physical therapy within 6 weeks of sport related concussion

Exclusion Criteria

• Family history of mood or anxiety disorder
• Diagnosis or treatment of migraine
• Diagnosed history of learning disability, ADHD (Attention Deficit Hyperactivity Disorder)
• Concussion history of 3 or more
• Other factors that would prevent subject from completing exertion protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of the current standard of care exertion protocol versus a newly developed program that emphasizes dynamic movement and sport-specific activities as measured by patient symtom scales and neurocognitive testing performance	4 weeks	To empirically assess the efficacy of the current standard of care as it relates to a gradual increase in physical activity relative to a newly developed program. The current standard of care focuses on heart rate and duration of physical activity where all athletes are progressed in the same fashion based on ability to tolerate symptoms while running on a treadmill; by contrast, the newly developed program emphasizes dynamic movement (incorporating lateral movement and planar changes in addition to treadmill running) that more closely approximate movements made while playing sports where rehabilitation is based on specific symptom deficits.

Trial Locations

Locations (1)

UMPC Sports Medicine Concussion Research Program; 🇺🇸 Pittsburgh, Pennsylvania, United States