- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06850662
Backward Walking Observation Training in People With Stroke and Gait Quality in Stroke
June 11, 2025 updated by: Yea-Ru Yang, National Yang Ming Chiao Tung University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yea-Ru Yang, PhD
- Phone Number: +886228267279
- Email: yryang@nycu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 112
- Recruiting
- Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
-
Contact:
- Yea-Ru Yang, PhD
- Phone Number: +886-2-2826-7279
- Email: yryang@nycu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Backward walking observation training group
The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks.
|
Backward treadmill training after watching a video of backward walking.
|
|
Active Comparator: Non-motor observational backward walking training group
The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks.
|
Backward treadmill training after watching a video of landscape without any movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 4 weeks after training, and 4-week follow-up
|
|
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
|
Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
|
|
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
|
Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait performance
Time Frame: Baseline, post-intervention, 4 weeks after training, and 4-week follow-up
|
Using GAITRite system to measure the gait spatiotemporal parameters
|
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
|
Using Time Up & Go test to assess functional mobility
|
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
|
Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities
|
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
|
Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling
|
Baseline, 4 weeks after training, and 4-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 30, 2028
Study Registration Dates
First Submitted
February 17, 2025
First Submitted That Met QC Criteria
February 22, 2025
First Posted (Actual)
February 27, 2025
Study Record Updates
Last Update Posted (Actual)
June 12, 2025
Last Update Submitted That Met QC Criteria
June 11, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU113210AF2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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