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Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Combined group
Cognitive group
Rhythmic group
Treadmill group
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, gait rehabilitation, rhythmic auditory stimulation, cognitive training

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mackay Memory Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

combined group

cognitive group

rhythmic group

treadmill group

Arm Description

The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing.

The cognitive group will receive cognitive training while walking on the treadmill.

The rhythmic group will hear rhythmic auditory stimulation while treadmill walking.

The treadmill group will train only in progressive treadmill walking.

Outcomes

Primary Outcome Measures

Walking speed (m/s)
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.
Stride time variability (%)
The stride time is the duration of one cycle (from heel strike to heel strike of the same side). Stride time variability (%) is the coefficient of variation of stride time or cycle duration in percent.
Gait asymmetry (%)
Gait asymmetry will be assessed by comparing left and right swing time, in percent. A perfect symmetry outputs a value of 0%.
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").

Secondary Outcome Measures

Dual-task 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. The walking speed and cognitive composite score under single-task and dual-task conditions will be used to calculate combined DTE.A negative cDTE value is indicative of automaticity under dual-task that deteriorated or interfered. A positive cDTE value indicates automaticity facilitation.
Task-specific dual-task interference
Task-specific dual-task interference calculates 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, quantifying the combined interference of the motor and the cognitive tasks may be a more comprehensive measure of the dual-task effect to provide a more accurate picture of gait automaticity. The walking speed and cognitive composite score will be used to calculate motor and cognitive dual-task effect (DTE). For both the motor (i.e., walking speed) and cognitive DTE in this study, negative DTE values (i.e., dual-task interfence) indicate poor performance under dual-task walking condition compared to single-task conditions.
6-minute Walking test, 6MWT
The 6-minute walk test will be used to measure participants' walking capacity and walking endurance.The participants will ask 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 will be recorded
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.
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.
Walking ability questionnaire
The walking ability questionnaire was designed to provide a more detailed assessment of the individual's social limitations due to reduced walking ability. A research assistant will administer the questionnaire to rate the participant's current customary mobility of 19 ambulatory activities performed in the home (8 items) and community (11 items). Current customary mobility was defined as an individual's self-reported ability to enter and leave the listed locations. Each test item is rated on a five-point ordinal scale (0-4, 0= unable, 1= wheelchair, 2="assisted, 3= supervised, 4= independent). An overall score was calculated. The range of scale was 0 to 76.
Outdoor walking assessment
Participants will walk 400 meters at their comfortable speed on the street. A 402-meter walkway will be used for outdoor walking test. In order to allow the participants to have enough distance to accelerate and decelerate, only the time taken the middle 400 meters will be recorded by a stopwatch. The outcome measure will be walking speed (m/s).

Full Information

First Posted
August 11, 2023
Last Updated
August 17, 2023
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT06000644
Brief Title
Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke
Official Title
Effects of Progressive Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training on Walking Automaticity, Executive Function, and Dual-task Coordination for Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung 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
The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.
Detailed Description
A single-blinded, randomized controlled trial will be conducted at medical centers. Eighty stroke patients will be randomized to one of the four 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 and rhythmic auditory stimulation while performing a cognitive task. The cognitive group will receive cognitive training while walking on the treadmill. The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. The treadmill group will train only in progressive treadmill walking. 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 of gait and cognition are gait speed and cognitive score of the Stroop task under single- and dual-task conditions. The secondary outcome measures are the Mini-BESTest, Walking Ability Questionnaire, 6-minute Walk Test, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between and within the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, gait rehabilitation, rhythmic auditory stimulation, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combined group
Arm Type
Experimental
Arm Description
The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing.
Arm Title
cognitive group
Arm Type
Active Comparator
Arm Description
The cognitive group will receive cognitive training while walking on the treadmill.
Arm Title
rhythmic group
Arm Type
Active Comparator
Arm Description
The rhythmic group will hear rhythmic auditory stimulation while treadmill walking.
Arm Title
treadmill group
Arm Type
Active Comparator
Arm Description
The treadmill group will train only in progressive treadmill walking.
Intervention Type
Device
Intervention Name(s)
Combined group
Intervention Description
The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Cognitive group
Intervention Description
The cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks .
Intervention Type
Device
Intervention Name(s)
Rhythmic group
Intervention Description
The rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Treadmill group
Intervention Description
The treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
Walking speed (m/s)
Description
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.
Time Frame
5 minutes
Title
Stride time variability (%)
Description
The stride time is the duration of one cycle (from heel strike to heel strike of the same side). Stride time variability (%) is the coefficient of variation of stride time or cycle duration in percent.
Time Frame
5 minutes
Title
Gait asymmetry (%)
Description
Gait asymmetry will be assessed by comparing left and right swing time, in percent. A perfect symmetry outputs a value of 0%.
Time Frame
5 minutes
Title
Cognitive composite score
Description
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").
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Dual-task automaticity
Description
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. The walking speed and cognitive composite score under single-task and dual-task conditions will be used to calculate combined DTE.A negative cDTE value is indicative of automaticity under dual-task that deteriorated or interfered. A positive cDTE value indicates automaticity facilitation.
Time Frame
5 minutes
Title
Task-specific dual-task interference
Description
Task-specific dual-task interference calculates 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, quantifying the combined interference of the motor and the cognitive tasks may be a more comprehensive measure of the dual-task effect to provide a more accurate picture of gait automaticity. The walking speed and cognitive composite score will be used to calculate motor and cognitive dual-task effect (DTE). For both the motor (i.e., walking speed) and cognitive DTE in this study, negative DTE values (i.e., dual-task interfence) indicate poor performance under dual-task walking condition compared to single-task conditions.
Time Frame
5 minutes
Title
6-minute Walking test, 6MWT
Description
The 6-minute walk test will be used to measure participants' walking capacity and walking endurance.The participants will ask 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 will be recorded
Time Frame
6 minutes
Title
Stroke impact scale, SIS
Description
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.
Time Frame
10 minutes
Title
Mini-Balance Evaluation System Test, Mini-BESTest
Description
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.
Time Frame
10 minutes
Title
Walking ability questionnaire
Description
The walking ability questionnaire was designed to provide a more detailed assessment of the individual's social limitations due to reduced walking ability. A research assistant will administer the questionnaire to rate the participant's current customary mobility of 19 ambulatory activities performed in the home (8 items) and community (11 items). Current customary mobility was defined as an individual's self-reported ability to enter and leave the listed locations. Each test item is rated on a five-point ordinal scale (0-4, 0= unable, 1= wheelchair, 2="assisted, 3= supervised, 4= independent). An overall score was calculated. The range of scale was 0 to 76.
Time Frame
5 minutes
Title
Outdoor walking assessment
Description
Participants will walk 400 meters at their comfortable speed on the street. A 402-meter walkway will be used for outdoor walking test. In order to allow the participants to have enough distance to accelerate and decelerate, only the time taken the middle 400 meters will be recorded by a stopwatch. The outcome measure will be walking speed (m/s).
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Ling Chuang, Ph.D.
Phone
886-3-2118800
Ext
3177
Email
lchunag@gap.cgu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Ling Chuang, Ph.D.
Phone
886-3-2118800
Ext
3177
Email
lchuang@mail.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ling Chuang, Ph.D.
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memory Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Ling Chuang, Ph.D.
Phone
886-3-2118800
Ext
3177
Email
lchuang@gap.cgu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke

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