An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Sponsor
University of Pittsburgh (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02389504
Collaborator
(none)
0
1
2
36.6
0

Study Details

Study Description

Brief Summary

An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic Exertional Physical Therapy
  • Other: Standard Exertional Physical Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 20, 2019
Anticipated Study Completion Date :
Jan 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Physical Therapy Protocol

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

Other: Standard Exertional Physical Therapy
Standard treadmill running, monitoring heart rate

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMPC Sports Medicine Concussion Research Program Pittsburgh Pennsylvania United States 15203

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anthony P. Kontos, Ph.D., Research Director, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02389504
Other Study ID Numbers:
  • PRO14070006
First Posted:
Mar 17, 2015
Last Update Posted:
Jan 16, 2019
Last Verified:
Jan 1, 2019
Keywords provided by Anthony P. Kontos, Ph.D., Research Director, University of Pittsburgh

Study Results

No Results Posted as of Jan 16, 2019