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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Other: Chronic stroke

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with chronic stroke who can walk outdoors

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic stroke; The data for motor function and gait pattern analysis was obtained.	Other: Chronic stroke; The data for motor function and gait pattern analysis was obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis	Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	5 minutes
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.	20 minutes
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.	10 minutes
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.	15 minutes
Range of Motion (ROM)	Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.	15 minutes
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.	10 minutes
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.	10 minutes

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 11, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Motor function; Gait pattern
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018-02-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No