Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment
Primary Purpose
Stroke, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive training combine treadmill training
Treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Cognitive Impairment, Cognitive and treadmill training
Eligibility 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
Sites / Locations
- National Yang-Ming University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cognitive training during treadmill training group
treadmill training group
Arm Description
Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.
Treadmill training as an active control.
Outcomes
Primary Outcome Measures
Trail-making test A&B
executive function (s)
Stroop test
attention (number)
Digit span test
memory (number)
Clock drawing test
visuospatial function (score 1-10)
Secondary Outcome Measures
Single walking performance- speed (cm/s)
walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system
Single walking performance-step length (cm)
step length in centimeters will be calculated during the single walking by using the GaitRite system
Single walking performance-step time (s)
step time in seconds will be calculated during the single walking by using the GaitRite system
Single walking performance-cadence (steps/min)
cadence in steps per minute will be calculated during the single walking by using the GaitRite system
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
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
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
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
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%
Full Information
NCT ID
NCT04545138
First Posted
August 13, 2020
Last Updated
October 12, 2022
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04545138
Brief Title
Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment
Official Title
Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
November 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Impairment
Keywords
Stroke, Cognitive Impairment, Cognitive and treadmill training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive training during treadmill training group
Arm Type
Experimental
Arm Description
Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.
Arm Title
treadmill training group
Arm Type
Active Comparator
Arm Description
Treadmill training as an active control.
Intervention Type
Other
Intervention Name(s)
cognitive training combine treadmill training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Trail-making test A&B
Description
executive function (s)
Time Frame
8 minutes
Title
Stroop test
Description
attention (number)
Time Frame
10 minutes
Title
Digit span test
Description
memory (number)
Time Frame
8 minutes
Title
Clock drawing test
Description
visuospatial function (score 1-10)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Single walking performance- speed (cm/s)
Description
walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system
Time Frame
3 minutes
Title
Single walking performance-step length (cm)
Description
step length in centimeters will be calculated during the single walking by using the GaitRite system
Time Frame
3 minutes
Title
Single walking performance-step time (s)
Description
step time in seconds will be calculated during the single walking by using the GaitRite system
Time Frame
3 minutes
Title
Single walking performance-cadence (steps/min)
Description
cadence in steps per minute will be calculated during the single walking by using the GaitRite system
Time Frame
3 minutes
Title
Cognitive dual task walking performance-speed (cm/s)
Description
walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system
Time Frame
3 minutes
Title
Cognitive dual task walking performance-step length (cm)
Description
step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system
Time Frame
3 minutes
Title
Cognitive dual task walking performance-step time (s)
Description
step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system
Time Frame
3 minutes
Title
Cognitive dual task walking performance-cadence (steps/min)
Description
cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system
Time Frame
3 minutes
Title
Cognitive dual task walking performance-dual task cost (%)
Description
dual task cost (%) will be calculated with the following formula: [(dual-task performance-single task performance) / single task performance] × 100%
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, professor
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun-Hsien Liu
Organizational Affiliation
National Yang Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
State/Province
Beitou District
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment
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