An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

NCT02389504 | Withdrawn

• 1 other identifier: PRO14070006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Conditions

Concussion

Keywords

Exertion; Efficacy of Treatment

Outcome Measures

Primary Outcomes (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

  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.

  4 weeks

Study Arms (2)

Standard Physical Therapy Protocol

ACTIVE COMPARATOR

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

Other: Standard Exertional Physical Therapy

Exertion Physical Therapy Protocol

EXPERIMENTAL

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

Interventions

Dynamic Exertional Physical Therapy 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.

Exertion Physical Therapy Protocol

Standard Exertional Physical Therapy OTHER

Standard treadmill running, monitoring heart rate

Standard Physical Therapy Protocol

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UMPC Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 17, 2015
• Study Start: January 1, 2016
• Primary Completion: January 20, 2019
• Study Completion: January 20, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

US (1)