Stroke SyndromeNCT04441541
Treadmill With Biofeedback on Gait Symmetry After Stroke
A study testing Treadmill with auditory feedback, Treadmill with visual feedback and Treadmill with auditory and visual feedback in people with Stroke Syndrome, run by National Yang Ming Chiao Tung University.
Trial summary
This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke Syndrome
- What is being tested?
- Treadmill with auditory feedback, Treadmill with visual feedback and Treadmill with auditory and visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single stroke experience
- Chronic stroke phase: stroke duration ≥ 6 months
- Independent gait: Functional Ambulation Category (FAC) ≥ 3
Who cannot join
- Cognitive problem (MMSE < 24)
- Visual or audio deficiency that might affect training
- Severe heart insufficiency or uncontrolled arterial hypertension
- Orthopedic disorders that affecting their gait
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke
This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.
- Conditions
- Stroke Syndrome
- Being tested
- Treadmill with auditory feedback, Treadmill with visual feedback, Treadmill with auditory and visual feedback, Treadmill training
- Keywords
- Gait training, Biofeedback, Treadmill, Gait symmetry
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill with auditory feedbackOther
Participants will receive training 3 times per week for 4 weeks (12 sessions).
Treadmill with visual feedbackOther
Participants will receive training 3 times per week for 4 weeks (12 sessions).
Treadmill with auditory and visual feedbackOther
Participants will receive training 3 times per week for 4 weeks (12 sessions).
Treadmill trainingOther
Participants will receive training 3 times per week for 4 weeks (12 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Treadmill with auditory feedback group | Experimental | Not described Receives: Other: Treadmill with auditory feedback |
| Treadmill with visual feedback group | Experimental | Not described Receives: Other: Treadmill with visual feedback |
| Treadmill with auditory and visual feedback group | Experimental | Not described Receives: Other: Treadmill with auditory and visual feedback |
| Treadmill training group | Active comparator | Not described Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial and temporal gait symmetry
Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)
Measured: Change from baseline at the first day, 4 weeks, and 8 weeks
Secondary outcomes (4)
Walking speed
Measured: Change from baseline at the first day, 4 weeks, and 8 weeks
6 Minute Walk Test
Measured: Change from baseline at the first day, 4 weeks, and 8 weeks
Timed up and Go test
Measured: Change from baseline at the first day, 4 weeks, and 8 weeks
Stroke Impact Scale
quality of life
Measured: Change from baseline at the first day, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SyndromeStudies 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
- 48 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
- NCT04441541
- Sponsor's protocol ID
- YM109073F
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04441541
- Acronym / sponsor ID
- YM109073F
- Conditions
- Stroke Syndrome
- Keywords
- Gait training, Biofeedback, Treadmill, Gait symmetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 22 Jun 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 study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treadmill with auditory feedback group | Experimental | Other: Treadmill with auditory feedback |
| Treadmill with visual feedback group | Experimental | Other: Treadmill with visual feedback |
| Treadmill with auditory and visual feedback group | Experimental | Other: Treadmill with auditory and visual feedback |
| Treadmill training group | Active comparator | Other: Treadmill training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single stroke experience
- Chronic stroke phase: stroke duration ≥ 6 months
- Independent gait: Functional Ambulation Category (FAC) ≥ 3
Key exclusion criteria (4 listed)
- Cognitive problem (MMSE < 24)
- Visual or audio deficiency that might affect training
- Severe heart insufficiency or uncontrolled arterial hypertension
- Orthopedic disorders that affecting their gait
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 |
|---|---|---|
| Treadmill with auditory feedbackParticipants will receive training 3 times per week for 4 weeks (12 sessions). | Other | Treadmill with auditory feedback group |
| Treadmill with visual feedbackParticipants will receive training 3 times per week for 4 weeks (12 sessions). | Other | Treadmill with visual feedback group |
| Treadmill with auditory and visual feedbackParticipants will receive training 3 times per week for 4 weeks (12 sessions). | Other | Treadmill with auditory and visual feedback group |
| Treadmill trainingParticipants will receive training 3 times per week for 4 weeks (12 sessions). | Other | Treadmill training group |
Primary outcome
Spatial and temporal gait symmetry
Time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)
4 secondary outcomes
Walking speed
Time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
6 Minute Walk Test
Time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Timed up and Go test
Time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Stroke Impact Scale
Time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill with auditory feedback, Treadmill with visual feedback and Treadmill with auditory and visual feedback in people with Stroke Syndrome, run by National Yang Ming Chiao Tung University.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yea-Ru, PhD (2826-7279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial and temporal gait symmetry (time frame: Change from baseline at the first day, 4 weeks, and 8 weeks). 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 22 Jun 2020.