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CompletedNCT03468166Updated Mar 1, 2023

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

An observational study in Chronic Stroke, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Stroke

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Keywords

  • Motor function
  • Gait pattern
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects with chronic stroke who can walk outdoors

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

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Chronic stroke

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

    Other: Chronic stroke

Interventions

  • OtherChronic stroke

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

05

What researchers measure

Primary outcomes

  1. Gait analysis

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

    Time frame: 1 hour

Secondary outcomes

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

    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.

    Time frame: 20 minutes

  2. The Timed Up and Go test (TUG)

    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.

    Time frame: 10 minutes

  3. 10 meter walk test (10MWT)

    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."

    Time frame: 5 minutes

  4. Manual Muscle Test (MMT)

    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.

    Time frame: 15 minutes

  5. Range of Motion (ROM)

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

    Time frame: 15 minutes

  6. Functional Ambulation Classification (FAC)

    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.

    Time frame: 10 minutes

  7. Modified Bathel index (MBI)

    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.

    Time frame: 10 minutes

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03468166
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Mar 19, 2018
Primary completion
Mar 29, 2022
Completion
Apr 19, 2022
Last update
Mar 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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