CHU d'ORLEANS
Orléans, 45067, France
Location status: Recruiting
NCT Number: NCT06589297
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Orléans, 45067, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acute stroke patients will undergo modified rankin scale
Time frame: 72 hours after stroke
Time frame: 72 hours after stroke
Time frame: 72 hours after stroke
Time frame: Month 6
The modified Rankin Scale is used to assess the disability of patients in the acute phase of stroke recovery. It consists of a single item, with 5 levels corresponding to no disability, mild disability, moderate disability, moderately severe disability and severe disability.
Time frame: Through month 3
The modified Rankin Scale is used to assess the disability of patients in the acute phase of stroke recovery. It consists of a single item, with 5 levels corresponding to no disability, mild disability, moderate disability, moderately severe disability and severe disability.
Time frame: 72 hours after stroke
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Régional d'Orléans
Other
Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke
Acronym: PREDISTROKE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07702968
Acute Stroke, Brain Diseases
Leiden, South Holland, Netherlands
View Trial DetailsNCT06763055
Acute Stroke, Acute intraCerebral Haemorrhage
Sydney, New South Wales, Australia
View Trial DetailsNCT07491952
Acute Stroke, Brain Diseases
Huntsville, Alabama, United States
View Trial DetailsNCT07627399
Acute Stroke, Body Temperature Changes
Antequera, Málaga, Spain
View Trial Details