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Completed

NCT Number: NCT04455334

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

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.

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Error-augmented treadmill training

Other

walk on split-belt treadmill

active control group

Other

walk on tie-belt treadmill

Error-augmented concept combined physical therapy group

Other

Error-augmented concept combined physical therapy

Conventional Physical Therapy Group

Other

conventional physical therapy

No intervention

Other

NO INTERVENTION

Primary outcomes

  1. Change of walking performance - Cadence

    Time frame: Change from Baseline cadence at 4 weeks

    The unit is steps per minutes

  2. Change of walking performance - Cadence

    Time frame: Change from Baseline cadence at 8 weeks

    The unit is steps per minutes

  3. Change of walking performance - stride time

    Time frame: Change from Baseline cadence at 4 weeks

    The unit is seconds

  4. Change of walking performance - stride time

    Time frame: Change from Baseline cadence at 8 weeks

    The unit is seconds

  5. Change of walking performance - stride length

    Time frame: Change from Baseline cadence at 4 weeks

    The unit is cm

  6. Change of walking performance - stride length

    Time frame: Change from Baseline cadence at 8 weeks

    The unit is cm

  7. Change of walking performance - swing cycle

    Time frame: Change from Baseline cadence at 4 weeks

    The unit is percentage (%)

  8. Change of walking performance - swing cycle

    Time frame: Change from Baseline cadence at 8 weeks

    The unit is percentage (%)

  9. Change of walking performance - symmetry ratio

    Time frame: Change from Baseline cadence at 4 weeks

    V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)

  10. Change of walking performance - symmetry ratio

    Time frame: Change from Baseline cadence at 8 weeks

    V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)

  11. Change of walking performance - variability

    Time frame: Change from Baseline cadence at 4 weeks

    CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)

  12. Change of walking performance - variability

    Time frame: Change from Baseline cadence at 8 weeks

    CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)

Secondary outcomes

  1. Brain activities over premotor cortex

    Time frame: Change from Baseline cadence at 4 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

  2. Brain activities over premotor cortex

    Time frame: Change from Baseline cadence at 8 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

  3. Brain activities over supplementary motor area

    Time frame: Change from Baseline cadence at 4 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

  4. Brain activities over supplementary motor area

    Time frame: Change from Baseline cadence at 8 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

  5. Brain activities over primary motor cortex

    Time frame: Change from Baseline cadence at 4 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

  6. Brain activities over primary motor cortex

    Time frame: Change from Baseline cadence at 8 weeks

    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

Other outcomes

  1. Dynamic Gait Index

    Time frame: Change from Baseline cadence at 4 weeks

  2. Dynamic Gait Index

    Time frame: Change from Baseline cadence at 8 weeks

  3. Fugl-Meyer assessment

    Time frame: Change from Baseline cadence at 4 weeks

    Sensorimotor impairment of lower extremity

  4. Fugl-Meyer assessment

    Time frame: Change from Baseline cadence at 8 weeks

    Sensorimotor impairment of lower extremity

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2020
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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