- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02098083
Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes (PBE)
29. juli 2015 opdateret af: Karen McCain, University of Texas Southwestern Medical Center
Evaluation of Physical Therapy Interventions and Patient Characteristics on Functional Mobility Outcomes in Persons With Acute Stroke
Data collection for this study will be done by clinicians working in inpatient rehabilitation units with persons with acute stroke.
No interventions are included in this study.
It is designed to capture trends in current clinical practice for persons with stroke.
This data will be useful in identifying the most beneficial and effective walking treatments as well as most significant patient characteristics that impact recovery for persons acutely after stroke.
All data collection will take place during the inpatient rehabilitation stay.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
All persons admitted to the inpatient rehabilitation unit will be screened for inclusion.
Only those with a confirmed diagnosis of stroke (CVA) will be included.
Data collection on the participants will begin at the time of admission and continue through discharge.
Average length of stay for persons with stroke in inpatient rehabilitation units is 21 days.
Some persons will stay fewer days and some will stay longer.
Data collection will include key information on physical therapy interventions including gait training, balance training, group therapy, manual therapy, exercise, transfer training, stairs, family training, wheelchair training, modalities, discharge planning, seated and supine exercises.
Other data will be collected including tone, motor control, sensation, gait endurance, falls, wounds, restraints, deep vein thrombosis, tracheostomy, feeding tubes and blood pressure.
Additional data collection will include age, gender, race, length of time post stroke, time in rehabilitation, Functional Independence Measure scores, case mix group, discharge destination.
In addition, physician history and physical as well as discharge summary will be collected, as will evaluation and discharge notes from therapies (physical, occupation, speech, social work).
Patients will not be responsible for any costs associated with this data collection.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Baylor Institute for Rehabilitation
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Frisco, Texas, Forenede Stater, 75034
- Baylor Institute for Rehabilitation Frisco
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Ft. Worth, Texas, Forenede Stater, 76104
- Baylor All Saints
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Irving, Texas, Forenede Stater, 75061
- Baylor Medical Center of Irving
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-
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
16 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Persons post stroke admitted to inpatient rehabilitation units
Beskrivelse
Inclusion Criteria:
- Any patient with a confirmed primary diagnosis of stroke, within 6 weeks of onset, will be included.
- Persons will be between the ages of 16 and 80.
- Persons may have experienced a previous CVA if they experienced a full gait recovery.
Exclusion Criteria:
- Any patient with a history of stroke onset greater than 6 weeks prior to admission will not be included.
- In addition, persons with bilateral CVA will not be included as well as persons who were not ambulatory prior to the CVA.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6-Minute Walk Test
Tidsramme: Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks
|
The 6-Minute Walk Test is a test of walking endurance that is valid and reliable for persons post stroke.
|
Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Karen J McCain, PT, DPT, NCS, University of Texas Southwestern Medical Center
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. november 2013
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
20. marts 2014
Først indsendt, der opfyldte QC-kriterier
26. marts 2014
Først opslået (Skøn)
27. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STU 092013-009
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 .