Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke
Effects of Progressive Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training on Walking Automaticity, Executive Function, and Dual-task Coordination for Patients With Chronic Stroke
1 other identifier
interventional
80
1 country
1
Brief Summary
The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2023
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
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
August 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2026
CompletedMarch 19, 2026
March 1, 2026
2.5 years
August 11, 2023
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Walking speed (m/s)
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.
5 minutes
Stride time variability (%)
The stride time is the duration of one cycle (from heel strike to heel strike of the same side). Stride time variability (%) is the coefficient of variation of stride time or cycle duration in percent.
5 minutes
Gait asymmetry (%)
Gait asymmetry will be assessed by comparing left and right swing time, in percent. A perfect symmetry outputs a value of 0%.
5 minutes
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").
5 minutes
Secondary Outcomes (7)
Dual-task automaticity
5 minutes
Task-specific dual-task interference
5 minutes
6-minute Walking test, 6MWT
6 minutes
Stroke impact scale, SIS
10 minutes
Mini-Balance Evaluation System Test, Mini-BESTest
10 minutes
- +2 more secondary outcomes
Study Arms (4)
combined group
EXPERIMENTALThe combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing.
cognitive group
ACTIVE COMPARATORThe cognitive group will receive cognitive training while walking on the treadmill.
rhythmic group
ACTIVE COMPARATORThe rhythmic group will hear rhythmic auditory stimulation while treadmill walking.
treadmill group
ACTIVE COMPARATORThe treadmill group will train only in progressive treadmill walking.
Interventions
The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks.
The cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks .
The rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
The treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
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
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
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
August 11, 2023
First Posted
August 21, 2023
Study Start
August 30, 2023
Primary Completion
February 23, 2026
Study Completion
February 23, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share