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OpenTrials
Completed

NCT Number: NCT04259307

Effect of Intensive Nutritional Support in Subacute Stroke Patient

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset

Exclusion criteria

  • Transient ischemic stroke
  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.
  • Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia 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, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Treatment and study plan

Omapone Peri 724mL or Winuf Peri 654mL

Drug

Additional intravenous nutrition of 500 kcal per day for 3 weeks

Other names: Comprehensive rehabilitation

Primary outcomes

  1. Korean modified Barthel Index (K-MBI) at 6 months after onset

    Time frame: 6 months after onset

    Korean modified Barthel Index (0~100)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Korean Center for Disease Control and Prevention

Registry information

Official study title

Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2020
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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