StrokeNCT06490276
Biofeedback Gait Training 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
Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual 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 2027
- 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 Biofeedback Gait Training on Gait Quality Post-stroke
Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.
- Conditions
- Stroke
- Being tested
- Gait training with biofeedback, Gait training without biofeedback
- Keywords
- Biofeedback, Gait symmetry, Gait variability, Gait training
- 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 60-minute session and 3 sessions/week, totaling 4 weeks. Receives: Other: Gait training with biofeedback |
| Gait training without biofeedback group | Active comparator | The intervention is a 60-minute session and 3 sessions/week, totaling 4 weeks. 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 saptiotemporal parameters
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Gait variability
Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Secondary outcomes (7)
Propulsive force
Using Force plate to measure the ground reaction force
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Gait performance
Using the GAITRite system to evaluate saptiotemporal parameters
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Berg Balance Scale
Using Berg Balance Scale to evaluate balance ability
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Activities-specific Balance Confidence Scale
Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Taiwan Chinese version Falls Efficacy Scale
Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Frenchay Activities Index
Using Frenchay Activities Index to measure individual's capacity to perform instrumental activities of daily living
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Stroke Impact Scale
Using Stroke Impact Scale to evaluate disability and quality of life after stroke
Measured: Change from baseline at 4 weeks after training and 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- NCT06490276
- Sponsor's protocol ID
- NYCU112205AF2
- 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 Biofeedback Gait Training on Gait Quality Post-stroke
- ClinicalTrials.gov ID
- NCT06490276
- Acronym / sponsor ID
- NYCU112205AF2
- Conditions
- Stroke
- Keywords
- Biofeedback, Gait symmetry, Gait variability, Gait training
- 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 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 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.
Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with 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 60-minute session and 3 sessions/week, totaling 4 weeks. |
| Gait training without biofeedback group | Active comparator | Other: Gait training without biofeedbackThe intervention is a 60-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 (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: Change from baseline at 4 weeks after training and 4 weeks follow-up
Using GAITRite system to measure the symmetry of saptiotemporal parameters
Gait variability
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters
7 secondary outcomes
Propulsive force
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Gait performance
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Berg Balance Scale
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Activities-specific Balance Confidence Scale
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Taiwan Chinese version Falls Efficacy Scale
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Frenchay Activities Index
Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Stroke Impact Scale
Time frame: Change from baseline at 4 weeks after training and 4 weeks 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 25 Feb 2025.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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: Change from baseline at 4 weeks after training and 4 weeks follow-up). 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.