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Error-augmented Walking on Gait Performance and Brain Activities in Stroke

Primary Purpose

Healthy, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Error-augmented treadmill training
active control group
Error-augmented concept combined physical therapy group
conventional physical therapy group
NO INTERVENTION
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The inclusion criteria of stroke participants are

  1. first unilateral stroke
  2. older than 20 years old
  3. medically stable
  4. lesion site limited in subcortical area
  5. having step length asymmetry (asymmetry ratio ≥ 1.08)
  6. ability to walk 10 meters independently without an assistive device.

The inclusion criteria of healthy participants are

  1. ability to walk 10 meters independently without an assistive device
  2. no any other neurological, psychological, or orthopedic disorders known to interfere the walking performance
  3. mini-mental status examination scores > 24 points

The exclusion criteria are

  1. Participants who are medical unstable
  2. cognitive impaired (mini-mental status examination scores < 24 points)
  3. diagnosed with other neurological, psychological, or orthopedic disorders known to interfere the participation to the study
  4. with the diagnosis which the contraindication includes exercise

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

healthy

stroke

active control group

Error-augmented treadmill training

Error-augmented concept combined physical therapy group

conventional physical therapy group

Arm Description

year 1 study

year 1 study

year 2 study

year 2 study

year 3 study

year 3 study

Outcomes

Primary Outcome Measures

Change of walking performance - Cadence
The unit is steps per minutes
Change of walking performance - Cadence
The unit is steps per minutes
Change of walking performance - stride time
The unit is seconds
Change of walking performance - stride time
The unit is seconds
Change of walking performance - stride length
The unit is cm
Change of walking performance - stride length
The unit is cm
Change of walking performance - swing cycle
The unit is percentage (%)
Change of walking performance - swing cycle
The unit is percentage (%)
Change of walking performance - symmetry ratio
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Change of walking performance - symmetry ratio
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Change of walking performance - variability
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)
Change of walking performance - variability
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)

Secondary Outcome Measures

Brain activities over premotor cortex
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over premotor cortex
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over supplementary motor area
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over supplementary motor area
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over primary motor cortex
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over primary motor cortex
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

Full Information

First Posted
June 22, 2020
Last Updated
June 16, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04455334
Brief Title
Error-augmented Walking on Gait Performance and Brain Activities in Stroke
Official Title
The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
June 3, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

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
This three-year study is proposed to document the effect and further implementation of error-augmented walking on gait performance and brain activities in individuals with stroke. Note that brain activations of post-stroke individuals during locomotion is a relatively unexplored realm. In the first year, study aims to observe the gait performance and brain activity of post-stroke and healthy participants when they walk on the split-belt treadmill, which inputs errors and causing adaptation during locomotion. Second year, study focuses on the long-term effect in aspect of brain activation and gait performance after training the post-stroke individuals with error-augmented treadmill walking. Lastly, study aim to investigate the long-term effect of practically applying the concept of error-augmented training strategy into clinical physical therapy. The first-year study is a cross-sectional study to recruit post-stroke and healthy participants. Gait performance will be measured by GaitUp system and brain activity during each walking trails will be measured concurrently by functional near infrared spectroscopy (fNIRS). Cadence, stride time, stride length and swing cycle are the gait parameters that will be recorded. Also, symmetry ratio and variability of temporal and spatial parameters will also be calculated. Brain area of interest in this study will be bilateral premotor cortex (PMC), supplementary motor area (SMA) and medial part of primary motor cortex (M1). Study will run one-way analysis of variance (ANOVA) with repeated measures and, if needed, Tukey post hoc test will be used to document the within group and between group differences with p<.05. The second year and third year study are single-blinded (assessor), randomized controlled trials. In the second year, study will recruit and randomize post-stroke participants into one of the two training groups, error-augmented treadmill training group (ETT group) and active control group (AC group). In ETT group, participants will practice split-belt treadmill walking. And participants in AC group will received traditional treadmill walking. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. There will be three evaluations, chronologically, on one day before intervention, one day after completion of intervention and one month after completion of intervention. Gait performance, brain activity, dynamic gait index and sensorimotor ability of lower extremity will be documented. Two-way ANOVA and Tukey post-hoc test will be used to determine the training and follow-up effects with p< .05. During the third year, individuals with stroke will be recruited and randomized to one of the two group, error-augmented concept combined physical therapy group (EAPT group) and conventional physical therapy group (CPT group). Participants in the CPT group will receive thirty-minute conventional physical therapy each session. Instead of training on a split-belt treadmill, participants in EAPT group will receive fifteen-minute walking trainings that implement the error-augmented concept and another fifteen-minute conventional physical therapy each session. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. The outcome measurements, and statistical analysis are the same as those described in the second year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Stroke
Keywords
error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
healthy
Arm Type
Other
Arm Description
year 1 study
Arm Title
stroke
Arm Type
Other
Arm Description
year 1 study
Arm Title
active control group
Arm Type
Active Comparator
Arm Description
year 2 study
Arm Title
Error-augmented treadmill training
Arm Type
Experimental
Arm Description
year 2 study
Arm Title
Error-augmented concept combined physical therapy group
Arm Type
Experimental
Arm Description
year 3 study
Arm Title
conventional physical therapy group
Arm Type
Active Comparator
Arm Description
year 3 study
Intervention Type
Other
Intervention Name(s)
Error-augmented treadmill training
Intervention Description
walk on split-belt treadmill
Intervention Type
Other
Intervention Name(s)
active control group
Intervention Description
walk on tie-belt treadmill
Intervention Type
Other
Intervention Name(s)
Error-augmented concept combined physical therapy group
Intervention Description
Error-augmented concept combined physical therapy
Intervention Type
Other
Intervention Name(s)
conventional physical therapy group
Intervention Description
conventional physical therapy
Intervention Type
Other
Intervention Name(s)
NO INTERVENTION
Intervention Description
NO INTERVENTION
Primary Outcome Measure Information:
Title
Change of walking performance - Cadence
Description
The unit is steps per minutes
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - Cadence
Description
The unit is steps per minutes
Time Frame
Change from Baseline cadence at 8 weeks
Title
Change of walking performance - stride time
Description
The unit is seconds
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - stride time
Description
The unit is seconds
Time Frame
Change from Baseline cadence at 8 weeks
Title
Change of walking performance - stride length
Description
The unit is cm
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - stride length
Description
The unit is cm
Time Frame
Change from Baseline cadence at 8 weeks
Title
Change of walking performance - swing cycle
Description
The unit is percentage (%)
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - swing cycle
Description
The unit is percentage (%)
Time Frame
Change from Baseline cadence at 8 weeks
Title
Change of walking performance - symmetry ratio
Description
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - symmetry ratio
Description
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Time Frame
Change from Baseline cadence at 8 weeks
Title
Change of walking performance - variability
Description
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)
Time Frame
Change from Baseline cadence at 4 weeks
Title
Change of walking performance - variability
Description
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)
Time Frame
Change from Baseline cadence at 8 weeks
Secondary Outcome Measure Information:
Title
Brain activities over premotor cortex
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 4 weeks
Title
Brain activities over premotor cortex
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 8 weeks
Title
Brain activities over supplementary motor area
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 4 weeks
Title
Brain activities over supplementary motor area
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 8 weeks
Title
Brain activities over primary motor cortex
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 4 weeks
Title
Brain activities over primary motor cortex
Description
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Time Frame
Change from Baseline cadence at 8 weeks
Other Pre-specified Outcome Measures:
Title
Dynamic Gait Index
Time Frame
Change from Baseline cadence at 4 weeks
Title
Dynamic Gait Index
Time Frame
Change from Baseline cadence at 8 weeks
Title
Fugl-Meyer assessment
Description
Sensorimotor impairment of lower extremity
Time Frame
Change from Baseline cadence at 4 weeks
Title
Fugl-Meyer assessment
Description
Sensorimotor impairment of lower extremity
Time Frame
Change from Baseline cadence at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criteria of stroke participants are first unilateral stroke older than 20 years old medically stable lesion site limited in subcortical area having step length asymmetry (asymmetry ratio ≥ 1.08) ability to walk 10 meters independently without an assistive device. The inclusion criteria of healthy participants are ability to walk 10 meters independently without an assistive device no any other neurological, psychological, or orthopedic disorders known to interfere the walking performance mini-mental status examination scores > 24 points The exclusion criteria are Participants who are medical unstable cognitive impaired (mini-mental status examination scores < 24 points) diagnosed with other neurological, psychological, or orthopedic disorders known to interfere the participation to the study with the diagnosis which the contraindication includes exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanci Liu, Ph.D
Phone
0233668135
Email
yanciliu@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanci Liu, Ph.D
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanci Liu, PHD
Phone
0233668135
Email
yanciliu@ntu.edu.tw

12. IPD Sharing Statement

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Error-augmented Walking on Gait Performance and Brain Activities in Stroke

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