Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0
NCT ID: NCT06096350
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
55 participants
OBSERVATIONAL
2024-05-29
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with stroke
Inpatients admitted to the investigators' rehabilitation facility
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.
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.
BIA, hand grip
bioimpedentiometric analyses of muscular mass (T0 and T1), muscular force with hand grip
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.
stool sampling
stool will be collected at T0 and at T1
urine sampling
the first morning urine will be collected at T0 and at T1
indirect calorimetry analysis
indirect calorimetry analysis with K5 (COSMED, Italy) during six minute walk test or timed up and go test.
Interventions
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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.
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.
BIA, hand grip
bioimpedentiometric analyses of muscular mass (T0 and T1), muscular force with hand grip
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.
stool sampling
stool will be collected at T0 and at T1
urine sampling
the first morning urine will be collected at T0 and at T1
indirect calorimetry analysis
indirect calorimetry analysis with K5 (COSMED, Italy) during six minute walk test or timed up and go test.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
90 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Irene Giovanna Aprile
Director of the Neurorehabilitation Department, Neurologist, Principal Investigator
Principal Investigators
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IRENE APRILE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Don Carlo Gnocchi Onlus
Locations
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Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Siotto M, Cocco C, Guerrini A, Bertoncini C, Germanotta M, Cipollini V, Cortellini L, Pavan A, Lattanzi S, Galluccio C, Insalaco S, Antonacci E, Ruco E, Aprile IG. Nutritional status in subacute post-stroke patients undergoing rehabilitation treatment: a protocol for a prospective observational study. BMC Sports Sci Med Rehabil. 2025 Jun 2;17(1):138. doi: 10.1186/s13102-025-01174-7.
Other Identifiers
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FDG_Nutristroke2_2023
Identifier Type: -
Identifier Source: org_study_id
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