Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment

Study Overview
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Brief Summary
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Post-stroke cognitive impairment is common in stroke survivors. Cognitive function is related to walking ability. The dual task walking is required for daily activities, however, such ability is even more challenging than single walking for people with stroke. The purpose of present study is to investigate the effects of combining cognitive and treadmill training on cognitive function and dual task walking performance in chronic stroke patients with cognitive impairment.

Detailed Description
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This is a single-blinded, randomized controlled trial with pre- and post-measurements. 24 subjects will be recruited, and randomly assigned to one of two groups: cognitive training during treadmill training group (experimental group) and treadmill training group (control group). The intervention for both group will be 30 minutes per session, 3 sessions per week for a total of 4 weeks. Statistical data analysis will use the SPSS 25.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to compare between time and groups. The significant level is set at 0.05.

Official Title
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Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment

Conditions
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Stroke, Cognitive Impairment

Intervention / Treatment
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* Other: cognitive training combine treadmill training
* Other: Treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 50 years old chronic stroke (onset >6 months) with mini-mental state examination (MMSE) score≧24 Montreal cognitive assessment (MoCA) score<26 (impaired cognition) ability to walk independently for at least 10 meters without assistive devices or support ability to read and write cognitive tests Exclusion Criteria: diagnosis of dementia unstable physical condition any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study visual or auditory disturbances

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive training during treadmill training group<br>Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously. | Other: cognitive training combine treadmill training<br>* Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10 12 points (slight), and ensures that patients can be cognitively trained at the same time. The cognitive training tasks will be projected on the screen and the participant have to answer the task orders during treadmill training simultaneously.<br>|
| Active Comparator: treadmill training group<br>Treadmill training as an active control. | Other: Treadmill training<br>* Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10 12 points (slight).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail-making test A&B | executive function (s) | 8 minutes | 
| Stroop test | attention (number) | 10 minutes | 
| Digit span test | memory (number) | 8 minutes | 
| Clock drawing test | visuospatial function (score 1-10) | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single walking performance- speed (cm/s) | walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system | 3 minutes | 
| Single walking performance-step length (cm) | step length in centimeters will be calculated during the single walking by using the GaitRite system | 3 minutes | 
| Single walking performance-step time (s) | step time in seconds will be calculated during the single walking by using the GaitRite system | 3 minutes | 
| Single walking performance-cadence (steps/min) | cadence in steps per minute will be calculated during the single walking by using the GaitRite system | 3 minutes | 
| Cognitive dual task walking performance-speed (cm/s) | walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system | 3 minutes | 
| Cognitive dual task walking performance-step length (cm) | step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system | 3 minutes | 
| Cognitive dual task walking performance-step time (s) | step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system | 3 minutes | 
| Cognitive dual task walking performance-cadence (steps/min) | cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system | 3 minutes | 
| Cognitive dual task walking performance-dual task cost (%) | dual task cost (%) will be calculated with the following formula: [(dual-task performance-single task performance) / single task performance] × 100% | 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Cognitive Impairment, Cognitive and treadmill training