Effect of Intensive Nutritional Support in Subacute Stroke Patient

Last updated: March 6, 2024
Sponsor: Samsung Medical Center
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Omapone Peri 724mL or Winuf Peri 654mL

Clinical Study ID

NCT04259307
2019-06-109
  • Ages > 19
  • All Genders

Study Summary

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute first-ever stroke patients less than 7 days after onset
  • more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI
  • body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ MiniNutritional Assessment < 12 before the comprehensive rehabilitation ⑥Fugl-Meyer assessment < 85 at 7 days after stroke onset

Exclusion

Exclusion Criteria:

  • Transient ischemic stroke
  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease, e.g., spinal cordinjury, Parkinson's disease, et al.
  • Pre-existing and active (e.g., on chronic medication) major psychiatricdisease, such as major depression, schizophrenia, bipolar disease ordementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g.,advanced hepatocellular carcinoma, end-stage renal failure, et al.)
  • A terminal medical diagnosis consistent with survival < 1 year
  • Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heartfailure) ⑧ Pregnant or lactating women ⑨ Prohibited fromtaking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: Omapone Peri 724mL or Winuf Peri 654mL
Phase:
Study Start date:
January 29, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

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