Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0
NCT06096350 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 55
Last updated 2024-06-18
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
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.
Sponsors & Collaborators
-
Fondazione Don Carlo Gnocchi Onlus
lead OTHER
Principal Investigators
-
IRENE APRILE, MD, PhD · Fondazione Don Carlo Gnocchi Onlus
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-29
- Primary Completion
- 2025-07-31
- Completion
- 2025-12-31
Countries
- Italy
Study Locations
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