StrokeNCT06504836
Kinematic Biofeedback on Gait Quality in Stroke
A study testing Gait training with biofeedback and Gait training without biofeedback in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance 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?
- Gait training with biofeedback and Gait training without biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 31 Dec 2025
- 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
- First stroke
- Stroke onset time ≥ 6 months
- Functional Ambulation Category ≥3
- Passive range of motion of affected hip extension is at least 10 degrees
- Mini-Mental State Measurement score ≥ 24 points
Who cannot join
- Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
- Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
- Uncorrected auditory impairment
- Severe cardiovascular disease or uncontrolled hypertension
- Other orthopedic diseases that may affect walking ability
- Other neurological disease except stroke
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: Effects of Kinematic Biofeedback on Gait Quality in People With Stroke
Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic stroke.
- Conditions
- Stroke
- Being tested
- Gait training with biofeedback, Gait training without biofeedback
- Keywords
- Biofeedback, Gait symmetry, Gait variability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with biofeedbackOther
Gait training include treadmill and overground walking. The biofeedback device system will provide real-time feedback on hip extension angles.
Gait training without biofeedbackOther
Gait training include treadmill and overground walking.
| Study group | Role | What they receive |
|---|---|---|
| Gait training with biofeedback group | Experimental | The intervention is a single 60-minute session. Receives: Other: Gait training with biofeedback |
| Gait training without biofeedback group | Active comparator | The intervention is a single 60-minute session. Receives: Other: Gait training without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait symmetry
Using GAITRite system to measure the symmetry of spatiotemporal parameters, including step length, step width, single support time, and double support time. Calculate the gait symmetry using following formula:
Gait symmetry = affected side/ unaffected side.
Measured: 1 day
Gait variability
Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV).
CV = standard deviation / mean * 100%
Measured: 1 day
Secondary outcomes (1)
Propulsive force
Using Force plate to measure the ground reaction force
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (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
- 40 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
- NCT06504836
- Sponsor's protocol ID
- NYCU112205AF1
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2024
- Last updated
- 25 Feb 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinematic Biofeedback on Gait Quality in People With Stroke
- ClinicalTrials.gov ID
- NCT06504836
- Acronym / sponsor ID
- NYCU112205AF1
- Conditions
- Stroke
- Keywords
- Biofeedback, Gait symmetry, Gait variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jul 2024 (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 disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality 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 |
|---|---|---|
| Gait training with biofeedback group | Experimental | Other: Gait training with biofeedbackThe intervention is a single 60-minute session. |
| Gait training without biofeedback group | Active comparator | Other: Gait training without biofeedbackThe intervention is a single 60-minute session. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First stroke
- Stroke onset time ≥ 6 months
- Functional Ambulation Category ≥3
- Passive range of motion of affected hip extension is at least 10 degrees
- Mini-Mental State Measurement score ≥ 24 points
Key exclusion criteria (6 listed)
- Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
- Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
- Uncorrected auditory impairment
- Severe cardiovascular disease or uncontrolled hypertension
- Other orthopedic diseases that may 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 |
|---|---|---|
| Gait training with biofeedbackGait training include treadmill and overground walking. The biofeedback device system will provide real-time feedback on hip extension angles. | Other | Gait training with biofeedback group |
| Gait training without biofeedbackGait training include treadmill and overground walking. | Other | Gait training without biofeedback group |
Primary outcome
Gait symmetry
Time frame: 1 day
Using GAITRite system to measure the symmetry of spatiotemporal parameters, including step length, step width, single support time, and double support time. Calculate the gait symmetry using following formula: Gait symmetry = affected side/ unaffected side.
Gait variability
Time frame: 1 day
Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean * 100%
1 secondary outcome
Propulsive force
Time frame: 1 day
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 25 Feb 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 Gait training with biofeedback and Gait training without biofeedback 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 5 inclusion and 6 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 25 Feb 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?
Gait symmetry (time frame: 1 day). The study lists 2 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 25 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.