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Multi-task Gait Training Mode to Enhance Walking Function in Patients With Chronic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The multi-task overground walking training
The multi-task treadmill walking training
Traditional rehabilitation
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 multi-task training, community ambulation, cognition

Eligibility Criteria

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

Inclusion Criteria:

  1. first-ever stroke with onset duration more than 3 months
  2. able to walk 10 m
  3. no severe vision, hearing, and language problems.

Exclusion Criteria:

  1. orthopedic and other neurological disorders that affect walking
  2. other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
  3. moderate or severe cognitive impairments (score < 24 on Mini-Mental State Examination)
  4. severe uncorrected visual deficits.

Sites / Locations

  • Mackay Memory HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

multi-task overground walking training

multi-task treadmill walking

traditional rehabilitation

Arm Description

The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks.

The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill.

Traditional rehabilitation group will train strength, balance, and gait.

Outcomes

Primary Outcome Measures

gait speed
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.
composite score
For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.

Secondary Outcome Measures

Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini-BESTest consists of 14 items and.includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is rated on a three-point ordinal scale (0 = severe, 1=moderate, and 2 = normal), with a maximum score of 28 points.
Timed Up and Go Test (TUG)
The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 m, turn, walk back, and sit down again. The score is the time to complete the test measured using a stopwatch. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).
Functional Gait Assessment (FGA)
The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
Berg Balance Scale (BBS)
The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke. The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.
6-minute Walk Test
Participants walk for 6-minute at comfortable speed to examine their walking endurance.
Physical activity monitor
Physical activity monitor will be examined by StepWatch TM Activity Monitor (Modus Health, Washington, DC) to objectively measure total walking step numbers of continually three days (except for sleep and bath).
Stroke Impact Scale Version 3.0 (SIS 3.0)
Health-related quality of life will be measured using the SIS 3.0, which is specific to the stroke population. The SIS 3.0 contains 59 items measuring 8 domains (i.e., strength, hand function, Activities of Daily Living/Instrumental Activities of Daily Living [ADL/IADL], mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Patient Global Impression of Change Scale (PGIC)
Participants will be evaluated regarding the participants' perception with the change in walking related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their walking function now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).

Full Information

First Posted
March 30, 2020
Last Updated
February 13, 2023
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT04328779
Brief Title
Multi-task Gait Training Mode to Enhance Walking Function in Patients With Chronic Stroke
Official Title
Multi-task Gait Training Mode to Enhance Walking Function, Cognitive Performance, Task Coordination, and Transfer to Community Ambulation in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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 investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).
Detailed Description
Only 7% patients can walk safely in the community. Functional community ambulation requires the ability of walking while performing other tasks. It is emergent to establish dual-task walking assessment with good psychometric properties and to identify the most effective approach that enhances dual-task walking performance for stroke patients. Our ongoing study found that motor tasks combined with cognitive dual-task training (multi-tasking ) have more improvements on cognitive performance of the Stroop task while walking than cognitive dual-task training alone. Therefore, combined motor and cognitive elements to walking training might be considered as a novel therapeutic strategy to promote functional ambulation and recovery of stroke patients. This combined strategy is based on attentional capacity sharing theory and the research advances on dual-task to enhance active participation and cognitive involvement, strengthen dual-task walking ability, then transfer to promote community ambulation and participation. However, lacking prospective, controlled trials quantify gait and cognition under dual-task conditions after multi-task walking training. Specifically, we will investigate psychometric properties of dual-task walking assessments for chronic stroke individuals. The second aim is to compare the immediate, retained, and transfer effects of of multi-task overground walking training to multi-task treadmill walking and traditional rehabilitation on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke. A metric analysis and comparative efficacy research will be conducted. Sixty chronic stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task walking assessments. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Sixty ambulatory stroke patients will be randomized to multi-task overground walking training or multi-task treadmill walking training or traditional rehabilitation. All three groups will receive interventions 3 times a week for 4 weeks. The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. Traditional rehabilitation will train strength, balance, and gait. A blinded assessor will administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing the Stroop task) at baseline, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Mini-BESTest, single- and dual-TUG, Functional Gait Assessment, 6-minute Walk Test, physical activity monitor, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
multi-task training, community ambulation, cognition

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
multi-task overground walking training
Arm Type
Experimental
Arm Description
The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks.
Arm Title
multi-task treadmill walking
Arm Type
Active Comparator
Arm Description
The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill.
Arm Title
traditional rehabilitation
Arm Type
Active Comparator
Arm Description
Traditional rehabilitation group will train strength, balance, and gait.
Intervention Type
Other
Intervention Name(s)
The multi-task overground walking training
Intervention Description
The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks for 30 minutes per session, 3 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
The multi-task treadmill walking training
Intervention Description
The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill for 30 minutes per session, 3 times a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation
Intervention Description
Traditional rehabilitation will train strength, balance, and gait for 30 minutes per session, 3 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
gait speed
Description
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.
Time Frame
5 minutes
Title
composite score
Description
For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Description
The Mini-BESTest consists of 14 items and.includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is rated on a three-point ordinal scale (0 = severe, 1=moderate, and 2 = normal), with a maximum score of 28 points.
Time Frame
10 minutes
Title
Timed Up and Go Test (TUG)
Description
The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 m, turn, walk back, and sit down again. The score is the time to complete the test measured using a stopwatch. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).
Time Frame
2 minutes
Title
Functional Gait Assessment (FGA)
Description
The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
Time Frame
10 minutes
Title
Berg Balance Scale (BBS)
Description
The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke. The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.
Time Frame
5-10 minutes
Title
6-minute Walk Test
Description
Participants walk for 6-minute at comfortable speed to examine their walking endurance.
Time Frame
6 minutes
Title
Physical activity monitor
Description
Physical activity monitor will be examined by StepWatch TM Activity Monitor (Modus Health, Washington, DC) to objectively measure total walking step numbers of continually three days (except for sleep and bath).
Time Frame
3 days
Title
Stroke Impact Scale Version 3.0 (SIS 3.0)
Description
Health-related quality of life will be measured using the SIS 3.0, which is specific to the stroke population. The SIS 3.0 contains 59 items measuring 8 domains (i.e., strength, hand function, Activities of Daily Living/Instrumental Activities of Daily Living [ADL/IADL], mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Time Frame
10 minutes
Title
Patient Global Impression of Change Scale (PGIC)
Description
Participants will be evaluated regarding the participants' perception with the change in walking related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their walking function now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).
Time Frame
1 minute

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: first-ever stroke with onset duration more than 3 months able to walk 10 m no severe vision, hearing, and language problems. Exclusion Criteria: orthopedic and other neurological disorders that affect walking other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity) moderate or severe cognitive impairments (score < 24 on Mini-Mental State Examination) severe uncorrected visual deficits.
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
lchuang@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
Individual Site Status
Recruiting
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
First Name & Middle Initial & Last Name & Degree
Li-Ling Chuang, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Multi-task Gait Training Mode to Enhance Walking Function in Patients With Chronic Stroke

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