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NCT Number: NCT06589297

Body Composition and Acute Stroke

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'ORLEANS

Orléans, 45067, France

Location status: Recruiting

Location contact

Marc VERIN, PUPH

CONTACT

[email protected]

0238651369

Marc VERIN, PUPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • volunteer stroke patients in acute phase
  • Age ≥ 18 years
  • Having had a brain MRI
  • Able to understand assessment guidelines
  • Not having objected to participate in the study after being duly informed

Exclusion criteria

  • Person under tutorship or curatorship
  • Person under court protection
  • Persons deprived of their liberty
  • Pregnant or breastfeeding women
  • Have a pacemaker or defibrillator

Treatment and study plan

Modified Rankin scale

Diagnostic Test

Acute stroke patients will undergo modified rankin scale

Primary outcomes

  1. phase angle

    Time frame: 72 hours after stroke

  2. thickness of temporal muscle

    Time frame: 72 hours after stroke

  3. surface area of temporal muscle

    Time frame: 72 hours after stroke

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    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.

  2. Modified Rankin Scale (mRS)

    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.

  3. skeletal muscular Index

    Time frame: 72 hours after stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Marc VERIN, PUPH

CONTACT

[email protected]

0238651369

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke

Acronym: PREDISTROKE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Feb 2, 2026

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.

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