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Completed

NCT Number: NCT03468166

Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke

In chronic stroke patients, the data for motor function and gait pattern analysis was obtained.

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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

  • Stroke patients with hemiplegia over 19 years old
  • Ischemic or hemorrhagic stroke patients over 6 months of onset
  • Functional Ambulation Category Scale with 3 or more scales and a person who can walk independently regardless of using of walking aids
  • A person who understands and voluntarily participates in this study and signs a research agreement

Exclusion criteria

  • Patients of artificial heartbeat
  • Patients with claustrophobia
  • Patients with intracranial metal implants
  • Patients who are contraindicated for other common MRI scans
  • Patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment
  • Those who have a score of FMA score of 80 or more and have very slight motor impairment

Treatment and study plan

Chronic stroke

Other

The data for motor function and gait pattern analysis was obtained.

Primary outcomes

  1. Gait analysis

    Time frame: 1 hour

    Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.

Secondary outcomes

  1. Fugl-Meyer assessment for lower extremity (FMA)

    Time frame: 20 minutes

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

  2. The Timed Up and Go test (TUG)

    Time frame: 10 minutes

    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

  3. 10 meter walk test (10MWT)

    Time frame: 5 minutes

    Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

  4. Manual Muscle Test (MMT)

    Time frame: 15 minutes

    Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.

  5. Range of Motion (ROM)

    Time frame: 15 minutes

    Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.

  6. Functional Ambulation Classification (FAC)

    Time frame: 10 minutes

    The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.

  7. Modified Bathel index (MBI)

    Time frame: 10 minutes

    The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 16, 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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