Dual-task Training During Curved Walking in Stroke Patients

June 5, 2025 updated by: Fooyin University

Effects of Dual-task Training During Curved Walking for Cognitive Function in Stroke Patients

The purpose of this study is to explore the effects of curved walking training under dual-task conditions on the cognitive function and walking ability of stroke patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: I-Hsuan Chen
  • Phone Number: 886-7-7811151#7043
  • Email: Y0894@fy.edu.tw

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Fooyin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. First-time unilateral stroke
  2. Age between 40 and 80 years
  3. Able to walk 10 meters continuously with or without the use of assistive devices
  4. Capable of following instructions and performing simple arithmetic
  5. Brunnstrom stage 3 or higher

Exclusion Criteria:

  1. Other neurological disease or unstable medical conditions
  2. Visual field defect
  3. Mini-Mental State Examination (MMSE) <24 points
  4. Pusher syndrome
  5. Half-sided neglect
  6. Expressive aphasia
  7. Poorly controlled hypertension or cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive tasks as the second task in addition to walking
Behavioral: cognitive dual-task group
Cognitive tasks as the second task in addition to walking
Other: walking without performing a second task during the walking training
Behavioral: Single-task group
walking without performing a second task during the walking training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination
Time Frame: From baseline to the end of treatment at 3 weeks
Mini-Mental State Examination (MMSE) includes items such as orientation, attention, memory, language, verbal comprehension, executive function, and construction ability. The maximum score is 30 points. A higher score indicates better cognitive function. One point is given for each correct answer. A total score below 24 suggests mild cognitive impairment, while a score below 16 indicates severe cognitive impairment.
From baseline to the end of treatment at 3 weeks
Trail Making Test
Time Frame: From baseline to the end of treatment at 3 weeks
The test consists of two parts, A and B. In part A, the participant is asked to connect a series of numbers in sequential order as quickly as possible. Part B includes both numbers and colors, where the participant must alternate between connecting the numbers and colors in order. The test records the time taken to complete the sequence and the number of errors made for scoring. If part B is not completed within 5 minutes, the test is stopped, and the highest score of 300 seconds is recorded. A lower score indicates faster completion time, suggesting better function.
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while turning - time
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a continuous curved path, without or with dual tasks. The time (seconds) taken to turn will be recorded using a stopwatch.
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while turning - numbers of steps
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a continuous curved path, without or with dual tasks. The numbers of steps taken to turn will be recorded using a counter.
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while turning - gait speed
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a continuous curved path, without or with dual tasks. Gait speed (m/s) will be recorded using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while turning - step length
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a continuous curved path, without or with dual tasks. Step length (cm) during gait will be recorded and analyzed using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while turning - step time
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a continuous curved path, without or with dual tasks. Step time (seconds) will be recorded and analyzed using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while straight-line walking - time
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a straight-line path, without or with dual tasks. The time taken to turn will be recorded using a stopwatch.
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while straight-line walking - numbers of steps
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a straight-line path, without or with dual tasks. The numbers of steps taken to turn will be recorded using a counter.
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while straight-line walking - gait speed
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a straight-line path, without or with dual tasks. Gait speed will be recorded using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while straight-line walking - step length
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a straight-line path, without or with dual tasks. Step length (cm) will be recorded using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Walking ability with different attention loads while straight-line walking - step time
Time Frame: From baseline to the end of treatment at 3 weeks
The participant will be asked to walk 10 meters in a straight-line path, without or with dual tasks. Step time (second) will be recorded using the commercially available portable gait analysis system (Gait Up).
From baseline to the end of treatment at 3 weeks
Timed up and go test
Time Frame: From baseline to the end of treatment at 3 weeks
This test requires a 3-meter distance to be marked on the floor, with a chair placed at one end. The time which the participant stands up, walks forward to the 3-meter mark, turns around, walks back to the chair, and sits down again will be calculated and recorded.
From baseline to the end of treatment at 3 weeks
Time taken to complete the Figure-of-Eight Walk test
Time Frame: From baseline to the end of treatment at 3 weeks
The figure-eight walking test path includes both straight and turning paths. The participant will first be asked to stand between two traffic cones, spaced 5 feet apart. They will then be instructed to walk forward, turn around the first cone in their preferred direction, return to the starting point, and then turn around the second cone in the opposite direction before returning to the center. The time taken to complete the figure-eight walking test will be recorded.
From baseline to the end of treatment at 3 weeks
Numbers of steps to complete the Figure-of-Eight Walk test
Time Frame: From baseline to the end of treatment at 3 weeks
The figure-eight walking test path includes both straight and turning paths. The participant will first be asked to stand between two traffic cones, spaced 5 feet apart. They will then be instructed to walk forward, turn around the first cone in their preferred direction, return to the starting point, and then turn around the second cone in the opposite direction before returning to the center. Numbers of steps to complete the Figure-of-Eight Walk test will be recorded.
From baseline to the end of treatment at 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: From baseline to the end of treatment at 3 weeks
This scale includes 14 test items. The scoring for each item ranges from 0 to 4. Generally, a score of 0 means the participant is completely unable to perform the test, while a score of 4 means the participant can complete the action within the specified time or achieve the maximum required distance or range of motion for the task. Each test item has a clear description of the scoring criteria. The total score is 56, and a higher score indicates better balance ability.
From baseline to the end of treatment at 3 weeks
Activities-Specific Balance Confidence scale
Time Frame: From baseline to the end of treatment at 3 weeks
This is a questionnaire that assesses the participant's level of self-confidence in maintaining balance in 16 situations commonly encountered in the community. Each of the 16 items is scored starting from 0, where 0 indicates no confidence, and scores increase in intervals of 10, with a maximum score of 100. A score of 100 represents complete confidence in maintaining balance.
From baseline to the end of treatment at 3 weeks
Number of falls
Time Frame: From baseline to the end of treatment at 3 weeks
The number of falls experienced by the participant in the past year will first be recorded. The participant will then be provided with a fall diary to track the number of falls during the one-year follow-up period after the assessment. In this study, a fall is defined as when the individual unintentionally falls to the ground, floor, or another lower level position. Each month, a follow-up phone call will be made to ensure the participant is recording the fall count as required.
From baseline to the end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fooyin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSVGH24-CT8-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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