Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training in Individuals With Chronic Stroke
- Conditions
- Stroke
- Interventions
- Device: Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) groupDevice: Treadmill Walking Training (TW)Device: Cognitive Treadmill Walking Training (CTW) group
- Registration Number
- NCT06392945
- Lead Sponsor
- Chang Gung University
- 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).
- Detailed Description
A single-blind, randomized controlled trial is conducted at medical centers. Ninety stroke patients will be randomized to one of the three groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). The cognitive group will receive cognitive training while walking at a progressive speed on the treadmill. The treadmill-alone group will train only in treadmill walking with progressive speed adjusted weekly. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures are gait and cognition under single- and dual-task conditions. The secondary outcome measures are the 6-minute Walk Test, Mini-BESTest, Stroke Impact Scale, and Walking Ability Questionnaire.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group The CTW+RAC group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). Treadmill Walking Training (TW) Treadmill Walking Training (TW) The TW group will train only in treadmill walking with progressive speed adjusted weekly. Cognitive Treadmill Walking Training (CTW) Cognitive Treadmill Walking Training (CTW) group The CTW group will receive cognitive training while walking at a progressive speed on the treadmill.
- Primary Outcome Measures
Name Time Method swing phase asymmetry under single-task walking and dual-task walking with the Stroop task baseline, after 4-week intervention, one-month follow-up Swing phase asymmetry (%) is the ratio of swing which compares the time in the air for the two feet, in percent.
stride length asymmetry under single-task walking and dual-task walking with the Stroop task baseline, after 4-week intervention, one-month follow-up 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%.
walking speed (m/s) under single-task walking and dual-task walking with the Stroop task baseline, after 4-week intervention, one-month follow-up 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.
cognitive composite score baseline, after 4-week intervention, one-month follow-up 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").
- Secondary Outcome Measures
Name Time Method Automaticity baseline, after 4-week intervention, one-month follow-up Automaticity is based on the combined interference of both motor (i.e., walking speed) and cognitive DTE. The combined dual-task effect (cDTE) is a measure that quantifies automaticity while performing a dual-task.
Mini-Balance Evaluation System Test, Mini-BESTest baseline, after 4-week intervention, one-month follow-up The Mini-BESTest is a reliable and valid tool for evaluating balance in people with chronic stroke. It consists of 14 items and includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each test item is rated on a three-point ordinal scale (0-2, 0=severe, 1=moderate, and 2=normal), with the total score ranging between 0 and 28 points.
Task-specific dual-task interference baseline, after 4-week intervention, one-month follow-up Task-specific dual-task interference is calculating the motor (i.e., walking speed) or cognitive dual-task effect (DTE), which relates dual-task performance to single-task performance. For assessing dual-task interference, quantifies the combined interference of the motor and the cognitive tasks may be a more comprehensive measure of dual-task effect to provide a more accurate picture of gait automaticity
6-minute Walking test, 6MWT baseline, after 4-week intervention, one-month follow-up The 6MWT is used to measure participants' walking capacity and walking endurance.The participants are asked to walk for six minutes at their own pace, resting or slowing down as needed, and the total distance (meters) of walking in six minutes.
Walking ability questionnaire baseline, after 4-week intervention, one-month follow-up Walking ability questionnaire was designed to provide a more detailed assessment of the individual's social limitations due to reduced walking ability. The questionnaire will be administered by a research assistant to rate the participant's current customary mobility of 19 ambulatory activities performed in the home (8 items) and community (11 items). Each item of walking ability is rated on a five-point ordinal scale (0-4, 0=unable to walk, 1=depend on wheel chair, 2=need assistance, 3=walking under supervision, and 4=independent walking), with the total score ranging between 0 and 76 points.
Stroke impact scale, SIS baseline, after 4-week intervention, one-month follow-up The SIS was developed to measure the quality of life after a stroke. The SIS 3.0 has eight domains: strength, hand function, mobility, activities of daily living/instrumental activities of daily living (i.e., ADLs and IADLs), memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better health-related quality of life. Lower scores indicate more incredible difficulty in task completion during the past week or past two weeks, or past four weeks. Eight items on the social participation domain and eight items on the mobility domain of the SIS will be used to measure the social participation of individuals with chronic stroke in this study.
Trial Locations
- Locations (1)
Mackay Memory Hospital
🇨🇳Taipei, Taiwan