Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589297
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Body Composition and Acute Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDISTROKE
Brief Summary:
Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients In this study the prognostic value of two bioimpedance parameters will be studied skeletal mass index and phase angle and two temporal muscle measurements thickness and surface area to predict the functional outcome of patients at discharge and at 6 months
Detailed Description:
A stroke commonly causes weakness and loss of independence Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices Various factors including the extent of the initial deficit or the size of the lesion have been shown to play a role in residual disability after stroke Premorbid physiological status has been less studied in stroke However loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery
In this work the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term discharge from the initial hospitalization and in the medium term follow-up visit at 6 months It will be studied using impedance analysis and morphological measurements on the temporal muscle
In a cohort study of hospitalized patients in the acute phase of a stroke measurements using a bioimpedance meter InBody BWA will be performed to measure a skeletal mass index SMI and phase angle The properties of the temporal muscle thickness and surface will also be measured at T1 within 72 first hours after the stroke Clinical and morphological data will also be collected weight height initial deficit lesion volume
The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later Functional assessment will be performed with modified Rankin score mRS
It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis
In this work the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term discharge from the initial hospitalization and in the medium term follow-up visit at 6 months It will be studied using impedance analysis and morphological measurements on the temporal muscle
In a cohort study of hospitalized patients in the acute phase of a stroke measurements using a bioimpedance meter InBody BWA will be performed to measure a skeletal mass index SMI and phase angle The properties of the temporal muscle thickness and surface will also be measured at T1 within 72 first hours after the stroke Clinical and morphological data will also be collected weight height initial deficit lesion volume
The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later Functional assessment will be performed with modified Rankin score mRS
It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None