StrokeNCT06850662
Backward Walking Observation Training in People With Stroke and Gait Quality in Stroke
A study testing Backward walking observation training and Non-motor observational backward walking training in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Walking impairment is one of the most common and concerning issues for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Backward walking observation training and Non-motor observational backward walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 6 months after the diagnosis of stroke
- Independent walking over at least 7m with or without a walking aid
- Mini-mental state examination score ≥ 24
Who cannot join
- Had difficulty in backward walking
- Any neuromuscular disorders history
- With visual or auditory disorders
- Unstable cardiac status or uncontrolled hypertension
- Any musculoskeletal disorders that would affect walking ability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-2826-7279, yryang@nycu.edu.tw
About this study
Official title: The Effect of Backward Walking Observation Training on Improving Brain Activity and Gait Quality in People With Stroke
Walking impairment is one of the most common and concerning issues for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. However, for people with chronic stroke, it may be more appropriate to prioritize improving gait symmetry and gait variability to enhance gait quality as a primary intervention goal. Additionally, stroke can lead to an imbalance in interhemispheric brain activity, which evolves as motor function recovers. According to the literature review, backward walking may extend the support time of the lower limbs, thereby enhancing the weight-bearing capacity of the affected limb. This, in turn, could promote gait symmetry and reduce gait variability. Changes in brain activity might also accompany such improvements in gait quality. Therefore, this study aims to investigate the immediate, short-term and post carryover intervention effects of backward walking observation training on gait quality in individuals with chronic stroke as well as to explore its effects on interhemispheric activity balance in individuals with chronic stroke.
- Conditions
- Stroke
- Being tested
- Backward walking observation training, Non-motor observational backward walking training
- Keywords
- Backward walking, Action observation training, Gait symmetry, Gait variability, Brain activity, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward walking observation trainingOther
Backward treadmill training after watching a video of backward walking.
Non-motor observational backward walking trainingOther
Backward treadmill training after watching a video of landscape without any movements.
| Study group | Role | What they receive |
|---|---|---|
| Backward walking observation training group | Experimental | The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks. Receives: Other: Backward walking observation training |
| Non-motor observational backward walking training group | Active comparator | The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks. Receives: Other: Non-motor observational backward walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.
Measured: Baseline, 4 weeks after training, and 4-week follow-up
Gait symmetry
Using GAITRite system to measure the symmetry of spatiotemporal parameters
Measured: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Gait varability
Using GAITRite system to measure the coefficient of variation of spatiotemporal parameters
Measured: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Secondary outcomes (4)
Gait performance
Using GAITRite system to measure the gait spatiotemporal parameters
Measured: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Time Up & Go test
Using Time Up \& Go test to assess functional mobility
Measured: Baseline, 4 weeks after training, and 4-week follow-up
Activities-specific Balance Confidence Scale
Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities
Measured: Baseline, 4 weeks after training, and 4-week follow-up
Taiwan Chinese version Falls Efficacy Scale
Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling
Measured: Baseline, 4 weeks after training, and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start24 Apr 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850662
- Sponsor's protocol ID
- NYCU113210AF2
- Status last verified
- Jun 2025
- First submitted
- 17 Feb 2025
- Last updated
- 12 Jun 2025
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Backward Walking Observation Training on Improving Brain Activity and Gait Quality in People With Stroke
- ClinicalTrials.gov ID
- NCT06850662
- Acronym / sponsor ID
- NYCU113210AF2
- Conditions
- Stroke
- Keywords
- Backward walking, Action observation training, Gait symmetry, Gait variability, Brain activity, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Feb 2025 (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.
Walking impairment is one of the most common and concerning issues for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. However, for people with chronic stroke, it may be more appropriate to prioritize improving gait symmetry and gait variability to enhance gait quality as a primary intervention goal. Additionally, stroke can lead to an imbalance in interhemispheric brain activity, which evolves as motor function recovers. According to the literature review, backward walking may extend the support time of the lower limbs, thereby enhancing the weight-bearing capacity of the affected limb. This, in turn, could promote gait symmetry and reduce gait variability. Changes in brain activity might also accompany such improvements in gait quality. Therefore, this study aims to investigate the immediate, short-term and post carryover intervention effects of backward walking observation training on gait quality in individuals with chronic stroke as well as to explore its effects on interhemispheric activity balance in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backward walking observation training group | Experimental | Other: Backward walking observation trainingThe intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks. |
| Non-motor observational backward walking training group | Active comparator | Other: Non-motor observational backward walking trainingThe intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 6 months after the diagnosis of stroke
- Independent walking over at least 7m with or without a walking aid
- Mini-mental state examination score ≥ 24
Key exclusion criteria (5 listed)
- Had difficulty in backward walking
- Any neuromuscular disorders history
- With visual or auditory disorders
- Unstable cardiac status or uncontrolled hypertension
- Any musculoskeletal disorders that would affect walking ability
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 |
|---|---|---|
| Backward walking observation trainingBackward treadmill training after watching a video of backward walking. | Other | Backward walking observation training group |
| Non-motor observational backward walking trainingBackward treadmill training after watching a video of landscape without any movements. | Other | Non-motor observational backward walking training group |
Primary outcome
Brain activity
Time frame: Baseline, 4 weeks after training, and 4-week follow-up
Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.
Gait symmetry
Time frame: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Using GAITRite system to measure the symmetry of spatiotemporal parameters
Gait varability
Time frame: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Using GAITRite system to measure the coefficient of variation of spatiotemporal parameters
4 secondary outcomes
Gait performance
Time frame: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
Time Up & Go test
Time frame: Baseline, 4 weeks after training, and 4-week follow-up
Activities-specific Balance Confidence Scale
Time frame: Baseline, 4 weeks after training, and 4-week follow-up
Taiwan Chinese version Falls Efficacy Scale
Time frame: Baseline, 4 weeks after training, and 4-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward walking observation training and Non-motor observational backward walking training in people with Stroke, run by National Yang Ming Chiao Tung University 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?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, PhD (+886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: Baseline, 4 weeks after training, and 4-week follow-up). The study lists 3 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 12 Jun 2025.