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

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ClinicalTrials.gov Identifier: NCT04545138
Recruitment Status : Not yet recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Yang Ming University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Cognitive Impairment Other: cognitive training combine treadmill training Other: Treadmill training Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment
Estimated Study Start Date : September 10, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: cognitive training during treadmill training group
Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.
 Other: cognitive training combine treadmill training
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.
Active Comparator: treadmill training group
Treadmill training as an active control.
 Other: Treadmill training
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).


Outcome Measures
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Primary Outcome Measures :
  1. Trail-making test A&B [ Time Frame: 8 minutes ]
    executive function (s)

  2. Stroop test [ Time Frame: 10 minutes ]
    attention (number)

  3. Digit span test [ Time Frame: 8 minutes ]
    memory (number)

  4. Clock drawing test [ Time Frame: 10 minutes ]
    visuospatial function (score 1-10)


Secondary Outcome Measures :
  1. Single walking performance- speed (cm/s) [ Time Frame: 3 minutes ]
    walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system

  2. Single walking performance-step length (cm) [ Time Frame: 3 minutes ]
    step length in centimeters will be calculated during the single walking by using the GaitRite system

  3. Single walking performance-step time (s) [ Time Frame: 3 minutes ]
    step time in seconds will be calculated during the single walking by using the GaitRite system

  4. Single walking performance-cadence (steps/min) [ Time Frame: 3 minutes ]
    cadence in steps per minute will be calculated during the single walking by using the GaitRite system

  5. Cognitive dual task walking performance-speed (cm/s) [ Time Frame: 3 minutes ]
    walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system

  6. Cognitive dual task walking performance-step length (cm) [ Time Frame: 3 minutes ]
    step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system

  7. Cognitive dual task walking performance-step time (s) [ Time Frame: 3 minutes ]
    step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system

  8. Cognitive dual task walking performance-cadence (steps/min) [ Time Frame: 3 minutes ]
    cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system

  9. Cognitive dual task walking performance-dual task cost (%) [ Time Frame: 3 minutes ]
    dual task cost (%) will be calculated with the following formula: [(dual-task performance-single task performance) / single task performance] × 100%


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545138


Contacts
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Contact: Ray-Yau Wang, professor 886-2-2826-7210 rywang@ym.edu.tw

Sponsors and Collaborators
National Yang Ming University
Investigators
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Principal Investigator: Ray-Yau Wang, professor National Yang Ming University
Study Chair: Yun-Hsien Liu National Yang Ming University
More Information
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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT04545138    
Other Study ID Numbers: YM109069F
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Yang Ming University:
Stroke
Cognitive Impairment
Cognitive and treadmill training
Additional relevant MeSH terms:
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Stroke
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders