Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04455334
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2020-06-22
Brief Title:
Error-augmented Walking on Gait Performance and Brain Activities in Stroke
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 p05
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
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 p05
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None