Dual-task Training During Curved Walking in Stroke Patients

NCT06898073 | Recruiting

• 1 other identifier: KSVGH24-CT8-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke Rehabilitation

Outcome Measures

Primary Outcomes (15)

• Mini-Mental State Examination

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Berg Balance Scale

  From baseline to the end of treatment at 3 weeks

• Activities-Specific Balance Confidence scale

  From baseline to the end of treatment at 3 weeks

• Number of falls

  From baseline to the end of treatment at 3 weeks

Study Arms (2)

Cognitive tasks as the second task in addition to walking

EXPERIMENTAL

Behavioral: cognitive dual-task group

walking without performing a second task during the walking training

OTHER

Behavioral: Single-task group

Interventions

cognitive dual-task group BEHAVIORAL

Cognitive tasks as the second task in addition to walking

Cognitive tasks as the second task in addition to walking

Single-task group BEHAVIORAL

walking without performing a second task during the walking training

walking without performing a second task during the walking training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Fooyin University

Kaohsiung City, Taiwan

RECRUITING

Central Study Contacts

I-Hsuan Chen

CONTACT

886-7-7811151#7043; Y0894@fy.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 27, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-03

Locations

TW (1)