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An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

14. januar 2019 opdateret af: Anthony P. Kontos, Ph.D., University of Pittsburgh
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15203
        • UMPC Sports Medicine Concussion Research Program

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard Physical Therapy Protocol
Regular Physical Therapy Protocol. Standard treadmill running, monitoring heart rate
Andet: Standard Exertional Physical Therapy
Standard treadmill running, monitoring heart rate
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Forventet)

20. januar 2019

Studieafslutning (Forventet)

20. januar 2019

Datoer for studieregistrering

Først indsendt

26. februar 2015

Først indsendt, der opfyldte QC-kriterier

10. marts 2015

Først opslået (Skøn)

17. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PRO14070006

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Standard Exertional Physical Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Costa Rica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner