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OpenTrials
Completed

NCT Number: NCT03428659

Functional Recovery Changes in Subacute Stroke Patients

In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset

Completed

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 19 years of age hemiplegic stroke patients
  • Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset
  • Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,
  • A person who understands and voluntarily participates in this study and signs a research agreement

Exclusion criteria

  • User of artificial heartbeat
  • Patients with claustrophobia
  • Patients with metal implants
  • Patients who are contraindicated for other common MRI
  • Patients with mild motor impairment with an FMA score of 80 or higher
  • Patients whose conscious state is coma and who have no response at all
  • Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease

Treatment and study plan

Data acquisition of functional abilities in sub-acute stroke

Other

MRI data, motor evoked potentials, gait function and behavior data acquisition

Primary outcomes

  1. Mechanism of recovery of motor function according to recovery of sub-acute stroke

    Time frame: Through study completion, an average of 6 months

    Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain

  2. Mechanism of recovery of gait function according to recovery of sub-acute stroke

    Time frame: Through study completion, an average of 6 months

    Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2018
Registry last updated
Mar 1, 2023

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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