- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898073
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: I-Hsuan Chen
- Phone Number: 886-7-7811151#7043
- Email: Y0894@fy.edu.tw
Study Locations
-
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- First-time unilateral stroke
- Age between 40 and 80 years
- Able to walk 10 meters continuously with or without the use of assistive devices
- Capable of following instructions and performing simple arithmetic
- Brunnstrom stage 3 or higher
Exclusion Criteria:
- Other neurological disease or unstable medical conditions
- Visual field defect
- Mini-Mental State Examination (MMSE) <24 points
- Pusher syndrome
- Half-sided neglect
- Expressive aphasia
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive tasks as the second task in addition to walking
|
Cognitive tasks as the second task in addition to walking
|
|
Other: walking without performing a second task during the walking training
|
walking without performing a second task during the walking training
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
March 12, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 20, 2025
First Posted (Actual)
March 27, 2025
Study Record Updates
Last Update Posted (Actual)
June 10, 2025
Last Update Submitted That Met QC Criteria
June 5, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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