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RECRUITING
NCT06096350

Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

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.

Official title: Study of Nutritional Status in Subacute Stroke Patients Under Rehabilitation Treatment

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

55

Start Date

2024-05-29

Completion Date

2025-12

Last Updated

2024-06-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

robotic assisted intervention

Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.

DIAGNOSTIC_TEST

hematochemical analysis

Blood samples of patients will be collected from patients in the early morning (7:30-9:00 a.m.) after an overnight fast at T0 and at T1. Sera samples will be separated by centrifugation (3,000 rpm, 10 min, and 4 °C), divided into 0.5 mL aliquots, and rapidly stored at -80 °C. Subjects' and reference samples were thawed just before the diagnostic test.

DEVICE

BIA, hand grip

bioimpedentiometric analyses of muscular mass (T0 and T1), muscular force with hand grip

DIAGNOSTIC_TEST

nutritional assessment, MNA,

nutritional status assessment will be performed by: body mass index measurements, (height and weight measurements at T0 and at T1); a Mini Nutritional Assessment survey will be administered to patients at admission; a food questionnaire will be administered to patients during from T0 to T1.

DIAGNOSTIC_TEST

stool sampling

stool will be collected at T0 and at T1

DIAGNOSTIC_TEST

urine sampling

the first morning urine will be collected at T0 and at T1

DEVICE

indirect calorimetry analysis

indirect calorimetry analysis with K5 (COSMED, Italy) during six minute walk test or timed up and go test.

Locations (1)

Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center

Roma, RM, Italy