- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04625933
The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
10 novembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
247
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Singapore, Singapour, 570186
- Tan Tock Seng Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional Independence Measure (FIM) on Admission
Délai: 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
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Functional Independence Measure (FIM) Gain
Délai: Within 72 hours
|
Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points
|
Within 72 hours
|
|
Mean Functional Independence Measure (FIM) efficiency
Délai: Through study completion, an average of 1 year
|
Mean FIM efficiency, calculated as [FIM gain]/ [rehabilitation length of stay (days)]
|
Through study completion, an average of 1 year
|
|
Mean Functional Independence Measure (FIM) effectiveness
Délai: Within 72 hours
|
Mean FIM effectiveness was calculated as FIM gain/(126 points-FIM admission scores) with a value of 0-1.
|
Within 72 hours
|
|
Body Mass Index (BMI)
Délai: 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.
|
Within 72 hours
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: SZE CHIN JONG, MD, Tan Tock Seng Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 janvier 2019
Achèvement primaire (Réel)
30 janvier 2020
Achèvement de l'étude (Réel)
30 juillet 2020
Dates d'inscription aux études
Première soumission
30 octobre 2020
Première soumission répondant aux critères de contrôle qualité
10 novembre 2020
Première publication (Réel)
12 novembre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NHG-DSRB 2018/01084
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .