NCT06096350

Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0

Study of Nutritional Status in Subacute Stroke Patients Under Rehabilitation Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-29
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2023-10-23
• Last updated: 2024-06-18

Locations

1 site across 1 country: Italy