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Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0 (Nutristroke2)

D

Don Carlo Gnocchi Onlus Foundation

Status

Enrolling

Conditions

Stroke

Treatments

Device: BIA, hand grip
Device: indirect calorimetry analysis
Diagnostic Test: nutritional assessment, MNA,
Diagnostic Test: stool sampling
Diagnostic Test: urine sampling
Device: robotic assisted intervention
Diagnostic Test: hematochemical analysis

Study type

Observational

Funder types

Other

Identifiers

NCT06096350
FDG_Nutristroke2_2023

Details and patient eligibility

About

The Nutristroke study's findings revealed a malnutrition scenario in post-stroke patients undergoing rehabilitation. This has highlighted the significance of a correct nutritional status assessment upon admission to a rehabilitation unit.

The aim of Nutristroke2, therefore, is the assessment of nutritional status, dietary intake, dysphagia, the presence of stroke-related sarcopenia, and systemic oxidative status in patients with subacute stroke outcomes before and after rehabilitation treatment.

A secondary aim is to assess whether there is any correlation between nutritional status, dietary intake, dysphagia, sarcopenia, and systemic oxidative status with rehabilitation outcomes.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance -Imaging (MRI) or Computed Tomography (CT);
  • time since stroke event within 6 months
  • sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent

Exclusion criteria

  • presence of a previous stroke based on the medical history;
  • behavioral and cognitive disorders that may interfere with the therapeutic activity;
  • other orthopedic or neurological complications that may interfere with the rehabilitation protocol;
  • inability to understand and sign informed consent;
  • the presence of pacemakers (for interference with bioimpedance measures).

Trial design

55 participants in 1 patient group

patients with stroke
Description:
Inpatients admitted to the investigators' rehabilitation facility
Treatment:
Diagnostic Test: hematochemical analysis
Device: robotic assisted intervention
Diagnostic Test: urine sampling
Diagnostic Test: stool sampling
Diagnostic Test: nutritional assessment, MNA,
Device: indirect calorimetry analysis
Device: BIA, hand grip

Trial contacts and locations

1

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Central trial contact

MARIACRISTINA SIOTTO, PhD; IRENE APRILE, MD, PhD

Data sourced from clinicaltrials.gov

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