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Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury

Background:

  • Traumatic brain injury (TBI) is a significant injury in the Armed Forces, but it is also common in the general population. This condition poses significant challenges for both diagnosis and therapy. However, the biological and neurological reasons for TBI remain poorly understood and are in need of more in-depth study.
  • The National Institutes of Health is collaborating with several military medical centers and research units in a multi-year study of TBI in civilian and military patients. In anticipation of these research projects, the Clinical Center s Rehabilitation Medicine Department needs to become familiar with the instruments they will likely need to evaluate this group of subjects.

Objectives:

  • To evaluate potential test instruments in patients with TBI.
  • To evaluate patient tolerance of an extensive battery of assessments and the time required to complete the assessments.
  • To improve staff competencies on new or novel assessments of the TBI patient population

Eligibility:

  • Individuals 18 years of age and older who have been diagnosed with a traumatic brain injury in the past 5 years.
  • Healthy volunteers 18 years of age and older who have had no instances of significant head trauma.

Design:

  • This study requires approximately 3 days of outpatient or inpatient evaluation.
  • Subjects will undergo cognitive and neuropsychological tests, physical assessments, speech and language evaluation, and balance testing. Tests will be given orally, in writing, and on computers. The testing will be done in blocks of 2 to 3 hours, with rest periods as needed.
  • Subjects may undergo any or all of the following assessments and screening tools, as determined by the researchers:
  • Cognitive, quality of life, and functional assessments
  • Speech, language, and swallowing assessments
  • Physical functional performance and environment assessments (including balance testing)
  • Subjects will remain under the care of their own health care providers while participating in this study.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

The objective of this study is to evaluate potential test instruments in the traumatic brain injury (TBI) patient population. We will assess outcome measures that test neuropsychological, cognitive, communicative, and physical functional outcomes on up to 60 patients with TBI and 20 healthy volunteers. Our aims are to evaluate the appropriateness of specific tests for TBI as well as to test patient tolerance of an extensive battery of assessments and the time required to complete the assessments. We will also focus on improving staff competencies as they relate to new or novel assessments on the TBI patient population.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

9

Kontakter og lokationer

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

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • INCLUSION CRITERIA:

    1. For TBI patients: a diagnosis of TBI within the last 5 years
    2. For Healthy volunteers: no episode of head trauma resulting in an alteration in level of consciousness or loss of memory for the event.

EXCLUSION CRITERIA:

For both study populations:

  1. Age less than 18 years
  2. Inability to speak or understand English well enough to complete study instruments
  3. Medically unstable on evaluation by an RMD physician, including those with clinically significant medical conditions that would make the research evaluations unsafe, logistically difficult or impossible to complete.
  4. Unable to provide informed consent.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

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

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

16. oktober 2009

Studieafslutning

16. maj 2014

Datoer for studieregistrering

Først indsendt

24. november 2009

Først indsendt, der opfyldte QC-kriterier

24. november 2009

Først opslået (Skøn)

25. november 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2017

Sidst verificeret

16. maj 2014

Mere information

Begreber relateret til denne undersøgelse

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 .

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