Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training in Individuals With Chronic Stroke
1 other identifier
interventional
90
1 country
1
Brief Summary
The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). The study's second aim is to investigate the factors affecting the improvement in community walking capacity after interventions and to explore whether changes in community walking capacity are associated with changes in participation after interventions (Aim 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started May 2024
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
March 19, 2026
March 1, 2026
3.2 years
April 26, 2024
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
walking speed (m/s) under single-task walking and dual-task walking with the Stroop task
Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.
baseline, after 4-week intervention, one-month follow-up
swing phase asymmetry under single-task walking and dual-task walking with the Stroop task
Swing phase asymmetry (%) is the ratio of swing which compares the time in the air for the two feet, in percent.
baseline, after 4-week intervention, one-month follow-up
stride length asymmetry under single-task walking and dual-task walking with the Stroop task
Stride length asymmetry (%) is the ratio of stride length which compares the stride length for the two feet, in percent. A perfect symmetry outputs a value of 0%.
baseline, after 4-week intervention, one-month follow-up
cognitive composite score
The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = \[Accuracy(%)/Reaction time(milliseconds)\] \* 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score. The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").
baseline, after 4-week intervention, one-month follow-up
Secondary Outcomes (6)
Task-specific dual-task interference
baseline, after 4-week intervention, one-month follow-up
Automaticity
baseline, after 4-week intervention, one-month follow-up
6-minute Walking test, 6MWT
baseline, after 4-week intervention, one-month follow-up
Stroke impact scale, SIS
baseline, after 4-week intervention, one-month follow-up
Mini-Balance Evaluation System Test, Mini-BESTest
baseline, after 4-week intervention, one-month follow-up
- +1 more secondary outcomes
Study Arms (3)
Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group
EXPERIMENTALThe CTW+RAC group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence).
Cognitive Treadmill Walking Training (CTW)
ACTIVE COMPARATORThe CTW group will receive cognitive training while walking at a progressive speed on the treadmill.
Treadmill Walking Training (TW)
ACTIVE COMPARATORThe TW group will train only in treadmill walking with progressive speed adjusted weekly.
Interventions
Participants in the TW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed only, without concurrent performing a cognitive task and no listening rhythmic auditory cueing. Same target treadmill speed will be used as the other two groups during treadmill walking. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the ground.
Participants in the CTW+RAC group participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. To increase adaptability to rhythmic auditory cueing prior to cognitive treadmill walking training, participants are required to keep stepping on their feet while listening to the auditory cueing using a metronome program (Metronome APP) for 5 minutes of warm up. Then they start walking on a treadmill with a target speed and perform a cognitive task concurrently while listening rhythmic auditory cueing. According to previous research, the target treadmill speed at week 1, week 2, week 3, and week 4 is gradually increased from 90%, 100%, 110%, to 120% baseline walking speed of comfortable walking on the ground. The beat of rhythmic auditory cueing using the Metronome APP on the smartphone is set at 110% of baseline cadence of comfortable walking on the ground based on a previous study in individuals with stroke.
Participants in the CTW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed and perform a cognitive task concurrently without rhythmic auditory cueing. Same cognitive training and target treadmill speed will be used as the CTW+RAC group during cognitive dual-task treadmill walking. Three cognitive training programs will be the verbal fluency, arithmetic, and visual distinguish tasks. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the 10 meters walk test at week 4.
Eligibility Criteria
You may qualify if:
- diagnosed with first-time stroke;
- more than 6 months after stroke onset;
- able to walk 10 meters;
- no severe vision, hearing, or speech impairments;
- understand and follow the instructions and sign the Informed Consent Form;
- older than 20 years old.
You may not qualify if:
- orthopedic problems affecting walking or other diseases that may interfere with study participation;
- a score of less than 24 on the mini-mental state examination (MMSE);
- severe balance disorder with a total score of less than 45 points Berg Balance Scale.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Universitylead
- National Science and Technology Councilcollaborator
Study Sites (1)
Mackay Memory Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Ling Chuang, Ph.D.
Chang Gung University
Central Study Contacts
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
April 26, 2024
First Posted
May 1, 2024
Study Start
May 24, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03