Stroke Clinical Trial
Official title:
Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training on Community Walking Capacity, Walking Automaticity, and Social Participation in Individuals With Chronic Stroke: a Randomized Controlled Trial
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).
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2027 |
Est. primary completion date | July 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memory Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Chang Gung University | National Science and Technology Council |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Task-specific dual-task interference | 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 | baseline, after 4-week intervention, one-month follow-up | |
Secondary | Automaticity | 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. | baseline, after 4-week intervention, one-month follow-up | |
Secondary | 6-minute Walking test, 6MWT | 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. | baseline, after 4-week intervention, one-month follow-up | |
Secondary | Stroke impact scale, SIS | 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. | baseline, after 4-week intervention, one-month follow-up | |
Secondary | Mini-Balance Evaluation System Test, Mini-BESTest | 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. | baseline, after 4-week intervention, one-month follow-up | |
Secondary | Walking ability questionnaire | 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. | baseline, after 4-week intervention, one-month follow-up |
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