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

The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04455334
Enrollment
54
Registered
2020-07-02
Start date
2020-07-13
Completion date
2022-12-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Stroke

Keywords

error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation

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.

Interventions

OTHERError-augmented treadmill training

walk on split-belt treadmill

OTHERactive control group

walk on tie-belt treadmill

OTHERError-augmented concept combined physical therapy group

Error-augmented concept combined physical therapy

conventional physical therapy

OTHERNO INTERVENTION

NO INTERVENTION

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change of walking performance - CadenceChange from Baseline cadence at 4 weeksThe unit is steps per minutes
Change of walking performance - stride timeChange from Baseline cadence at 4 weeksThe unit is seconds
Change of walking performance - stride lengthChange from Baseline cadence at 4 weeksThe unit is cm
Change of walking performance - swing cycleChange from Baseline cadence at 4 weeksThe unit is percentage (%)
Change of walking performance - symmetry ratioChange from Baseline cadence at 4 weeksV(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Change of walking performance - variabilityChange from Baseline cadence at 4 weeksCV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)

Secondary

MeasureTime frameDescription
Brain activities over premotor cortexChange from Baseline cadence at 4 weeksA 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 areaChange from Baseline cadence at 4 weeksA 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 cortexChange from Baseline cadence at 4 weeksA multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORYanci Liu, Ph.D

National Taiwan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026