HealthyNCT04455334
Error-augmented Walking on Gait Performance and Brain Activities in Stroke
A study testing Error-augmented treadmill training, Error-augmented concept combined physical therapy group and conventional physical therapy group in people with Healthy and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- What is being tested?
- Error-augmented treadmill training, Error-augmented concept combined physical therapy group and conventional physical therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With 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.
- Being tested
- Error-augmented treadmill training, active control group, Error-augmented concept combined physical therapy group, conventional physical therapy group, NO INTERVENTION
- Keywords
- error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error-augmented treadmill trainingOther
walk on split-belt treadmill
active control groupOther
walk on tie-belt treadmill
Error-augmented concept combined physical therapy groupOther
Error-augmented concept combined physical therapy
conventional physical therapy groupOther
conventional physical therapy
NO INTERVENTIONOther
NO INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| healthy | Other | year 1 study Receives: Other: NO INTERVENTION |
| stroke | Other | year 1 study Receives: Other: NO INTERVENTION |
| active control group | Active comparator | year 2 study Receives: Other: active control group |
| Error-augmented treadmill training | Experimental | year 2 study Receives: Other: Error-augmented treadmill training |
| Error-augmented concept combined physical therapy group | Experimental | year 3 study Receives: Other: Error-augmented concept combined physical therapy group |
| conventional physical therapy group | Active comparator | year 3 study Receives: Other: conventional physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of walking performance - Cadence
The unit is steps per minutes
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - Cadence
The unit is steps per minutes
Measured: Change from Baseline cadence at 8 weeks
Change of walking performance - stride time
The unit is seconds
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - stride time
The unit is seconds
Measured: Change from Baseline cadence at 8 weeks
Change of walking performance - stride length
The unit is cm
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - stride length
The unit is cm
Measured: Change from Baseline cadence at 8 weeks
Change of walking performance - swing cycle
The unit is percentage (%)
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - swing cycle
The unit is percentage (%)
Measured: Change from Baseline cadence at 8 weeks
Change of walking performance - symmetry ratio
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - symmetry ratio
V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Measured: Change from Baseline cadence at 8 weeks
Change of walking performance - variability
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)
Measured: Change from Baseline cadence at 4 weeks
Change of walking performance - variability
CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)
Measured: Change from Baseline cadence at 8 weeks
Secondary outcomes (6)
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.
Measured: Change from Baseline cadence at 4 weeks
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.
Measured: Change from Baseline cadence at 8 weeks
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.
Measured: Change from Baseline cadence at 4 weeks
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.
Measured: Change from Baseline cadence at 8 weeks
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.
Measured: Change from Baseline cadence at 4 weeks
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.
Measured: Change from Baseline cadence at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start13 Jul 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanci Liu, Ph.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455334
- Sponsor's protocol ID
- 202004042RIND
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT04455334
- Acronym / sponsor ID
- 202004042RIND
- Keywords
- error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| healthy | Other | Other: NO INTERVENTIONyear 1 study |
| stroke | Other | Other: NO INTERVENTIONyear 1 study |
| active control group | Active comparator | Other: active control groupyear 2 study |
| Error-augmented treadmill training | Experimental | Other: Error-augmented treadmill trainingyear 2 study |
| Error-augmented concept combined physical therapy group | Experimental | Other: Error-augmented concept combined physical therapy groupyear 3 study |
| conventional physical therapy group | Active comparator | Other: conventional physical therapy groupyear 3 study |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Error-augmented treadmill trainingwalk on split-belt treadmill | Other | Error-augmented treadmill training |
| active control groupwalk on tie-belt treadmill | Other | active control group |
| Error-augmented concept combined physical therapy groupError-augmented concept combined physical therapy | Other | Error-augmented concept combined physical therapy group |
| conventional physical therapy groupconventional physical therapy | Other | conventional physical therapy group |
| NO INTERVENTIONNO INTERVENTION | Other | healthy, stroke |
Primary outcome
Change of walking performance - Cadence
Time frame: Change from Baseline cadence at 4 weeks
The unit is steps per minutes
Change of walking performance - Cadence
Time frame: Change from Baseline cadence at 8 weeks
The unit is steps per minutes
Change of walking performance - stride time
Time frame: Change from Baseline cadence at 4 weeks
The unit is seconds
Change of walking performance - stride time
Time frame: Change from Baseline cadence at 8 weeks
The unit is seconds
Change of walking performance - stride length
Time frame: Change from Baseline cadence at 4 weeks
The unit is cm
Change of walking performance - stride length
Time frame: Change from Baseline cadence at 8 weeks
The unit is cm
Change of walking performance - swing cycle
Time frame: Change from Baseline cadence at 4 weeks
The unit is percentage (%)
Change of walking performance - swing cycle
Time frame: Change from Baseline cadence at 8 weeks
The unit is percentage (%)
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)
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)
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)
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)
6 secondary outcomes
Brain activities over premotor cortex
Time frame: Change from Baseline cadence at 4 weeks
Brain activities over premotor cortex
Time frame: Change from Baseline cadence at 8 weeks
Brain activities over supplementary motor area
Time frame: Change from Baseline cadence at 4 weeks
Brain activities over supplementary motor area
Time frame: Change from Baseline cadence at 8 weeks
Brain activities over primary motor cortex
Time frame: Change from Baseline cadence at 4 weeks
Brain activities over primary motor cortex
Time frame: Change from Baseline cadence at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanci Liu, Ph.D principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error-augmented treadmill training, Error-augmented concept combined physical therapy group and conventional physical therapy group in people with Healthy and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of walking performance - Cadence (time frame: Change from Baseline cadence at 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.