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Metadata

Name
Error-augmented Walking on Gait Performance and Brain Activities in Stroke
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT04455334
Description
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.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2020
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT04455334

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