StrokeNCT05020886
Turning Performance in Stroke
An observational study of Stroke, run by National Yang Ming Chiao Tung University.
Trial summary
Turning is a challenging task for stroke patient. Previous studies showed that turning is one of the activities which resulting in falling frequently in stroke. However, the assessment tool of turning performance is still lack of reliability and validity. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- turning task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Jul 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke
Who may be able to join
- 6 months after first stroke.
- Able to independently walk 7 meter at least without any device
- MMSE score ≧ 24
Who cannot join
- Unstable medical conditions (such as deep vein thrombosis)
- Any disease which has known affecting walk(heart failure, diabetes)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Turning is a challenging task for stroke patient. Previous studies showed that turning is one of the activities which resulting in falling frequently in stroke. However, the assessment tool of turning performance is still lack of reliability and validity. Furthermore, the main factors which affected turning ability in stroke are not approved yet.
- Conditions
- Stroke
- Being tested
- turning task
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turning taskBehavioural
Several trials included bilateral turning in 30, 60, 90, 120, 150, 180 degree.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Behavioral: turning task | |
| Stroke | Not described Receives: Behavioral: turning task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning angle
Measured: 10 minutes
Turning time
Measured: 10 minutes
Turning step
Measured: 10 minutes
Single leg supported time during turning
Measured: 10 minutes
Swing time during turning
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT05020886
- Sponsor's protocol ID
- YM109175E
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2021
- Last updated
- 25 Aug 2021
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05020886
- Acronym / sponsor ID
- YM109175E
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 25 Aug 2021 (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.
Turning is a challenging task for stroke patient. Previous studies showed that turning is one of the activities which resulting in falling frequently in stroke. However, the assessment tool of turning performance is still lack of reliability and validity. Furthermore, the main factors which affected turning ability in stroke are not approved yet.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Behavioral: turning task |
| Stroke | – | Behavioral: turning task |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke
Key inclusion criteria (3 listed)
- 6 months after first stroke.
- Able to independently walk 7 meter at least without any device
- MMSE score ≧ 24
Key exclusion criteria (2 listed)
- Unstable medical conditions (such as deep vein thrombosis)
- Any disease which has known affecting walk(heart failure, diabetes)
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 |
|---|---|---|
| turning taskSeveral trials included bilateral turning in 30, 60, 90, 120, 150, 180 degree. | Behavioural | Healthy, Stroke |
Primary outcome
Turning angle
Time frame: 10 minutes
Turning time
Time frame: 10 minutes
Turning step
Time frame: 10 minutes
Single leg supported time during turning
Time frame: 10 minutes
Swing time during turning
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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?
An observational study of Stroke, 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 2 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 25 Aug 2021. 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 Yea-Ru Yang, Ph.D. (+886-2-2826-7279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning angle (time frame: 10 minutes). The study lists 5 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 Aug 2021.