An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

NCT ID: NCT02389504

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-20

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.

Conditions

Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Physical Therapy Protocol

Regular Physical Therapy Protocol. Standard treadmill running, monitoring heart rate

Group Type: ACTIVE_COMPARATOR

Standard Exertional Physical Therapy

Intervention Type: OTHER

Standard treadmill running, monitoring heart rate

Exertion Physical Therapy Protocol

Exertional Physical Therapy Protocol. 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.

Group Type: EXPERIMENTAL

Dynamic Exertional Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Standard Exertional Physical Therapy

Standard treadmill running, monitoring heart rate

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Anthony P. Kontos, Ph.D.

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMPC Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14070006

Identifier Type: -

Identifier Source: org_study_id