- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04625933
The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
10. november 2020 opdateret af: Jong Sze Chin, Tan Tock Seng Hospital
Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes.
Some data demonstrating that gains are often more rapid at BMI above "normal".
The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
247
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Singapore, Singapore, 570186
- Tan Tock Seng Hospital
-
-
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patient admitted to Tan Tock Seng Tertiary Rehabilitation Centre and fulfilled the inclusion criteria within the study period will be consented to the study.
Beskrivelse
Inclusion Criteria:
- clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
- aged 18 years and above
- admitted directly from acute stroke units
- able to provide informed consent by self or by next of kin in incompetence patient
- must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes
Exclusion Criteria:
- rehabilitation was not the primary reason for the inpatient admission
- failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
- incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
- patients who were not of Asian ethnicity
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 |
---|---|---|
Functional Independence Measure (FIM) on Admission
Tidsramme: Functional Independence Measure (FIM) was measured within 72 hours of admission
|
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM.
The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition).
Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
|
Functional Independence Measure (FIM) was measured within 72 hours of admission
|
Functional Independence Measure (FIM) on Discharge
Tidsramme: Functional Independence Measure (FIM) was measured within 72 hours of discharge.
|
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM.
The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition).
Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
|
Functional Independence Measure (FIM) was measured within 72 hours of discharge.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Functional Independence Measure (FIM) Gain
Tidsramme: Within 72 hours
|
Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points
|
Within 72 hours
|
Mean Functional Independence Measure (FIM) efficiency
Tidsramme: Through study completion, an average of 1 year
|
Mean FIM efficiency, calculated as [FIM gain]/ [rehabilitation length of stay (days)]
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Through study completion, an average of 1 year
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Mean Functional Independence Measure (FIM) effectiveness
Tidsramme: Within 72 hours
|
Mean FIM effectiveness was calculated as FIM gain/(126 points-FIM admission scores) with a value of 0-1.
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Within 72 hours
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Body Mass Index (BMI)
Tidsramme: Within 72 hours
|
All patients had their weight (in kilograms) and height (in meters) measured on admission and discharge by rehabilitation nurses 72 hours after rehabilitation admission and prior to planned rehabilitation discharge.
Weight was measured via sitting weighing scales or platform weighing scale for bedbound patients while height was measured with height measuring scale or measured in a supine position with legs outstretched and feet in dorsiflexion at end of bed for bedbound patients.
BMI is then calculated as weight /height in meters squared.
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Within 72 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: SZE CHIN JONG, MD, Tan Tock Seng Hospital
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 (Faktiske)
31. januar 2019
Primær færdiggørelse (Faktiske)
30. januar 2020
Studieafslutning (Faktiske)
30. juli 2020
Datoer for studieregistrering
Først indsendt
30. oktober 2020
Først indsendt, der opfyldte QC-kriterier
10. november 2020
Først opslået (Faktiske)
12. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NHG-DSRB 2018/01084
Plan for individuelle deltagerdata (IPD)
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