Chronic StrokeNCT06191406
Five-year Changes in Patients With Chronic Stroke
An observational study of Chronic Stroke, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Objective of the study: To determine changes in physical and cognitive function in patients with chronic stroke over 5 years To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- 6 minute walk test
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2023to 1 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study: Validity and Test-Retest Reliability of a Thai Stroke Physical Activity Questionnaire) which the population was stroke patients, aged ≥ 18 years with onset > 3 months. The study population is composed of patients who have achieved a compliance rate of more than 70% with the accelerometer within 1 week, total 50 people.
Who may be able to join
- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Five-year Changes in Physical and Cognitive Function in Patients With Chronic Stroke: a Preliminary Retrospective Cohort Study
Objective of the study:
- To determine changes in physical and cognitive function in patients with chronic stroke over 5 years
- To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity
- Conditions
- Chronic Stroke
- Being tested
- 6 minute walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk testDiagnostic test
Also called 10 meters walk test, Thai MMSE
Test for physical functions and cognitive functions
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
walk distance covered over a time of 6 minutes
Measured: 5 years
10-meter walk test
comfortable \& fast gait speed
Measured: 5 years
Thai MMSE
test patient's cognition with mini-mental state examination (MMSE) Minimum score = 0 (worst outcome, poor cognitive function) Maximum score = 30 (better outcome, good cognitive function)
Measured: 5 years
Secondary outcomes (4)
Global quality of life
Global quality of life questionnaire which the patient will give their own score of their quality of life, scale from 0-100 (0 = worst quality of life, 100 = best quality of life)
Measured: 5 years
Short FES-I
the Short Falls Efficacy Scale International (Short FES-I) questionnaire Minimum score = 7 (better outcome, less fear of falling) Maximum score = 28 (worst outcome, most fear of falling)
Measured: 5 years
Fatigue assessment scale
Fatigue assessment scale questionnaire Minimum score = 10 (better outcome, less fatigue) Maximum score = 50 (worst outcome, more fatigue)
Measured: 5 years
Barthel index
Barthel index questionnaire Minimum score = 0 (worst outcome, mostly dependent in daily living) Maximum score = 100 (better outcome, independent in daily living)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Nov 2023
- Primary completion1 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanisa Sinthunyathum, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191406
- Sponsor's protocol ID
- HE661406
- Status last verified
- Oct 2024
- First submitted
- 9 Dec 2023
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Changes in Physical and Cognitive Function in Patients With Chronic Stroke: a Preliminary Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06191406
- Acronym / sponsor ID
- HE661406
- Conditions
- Chronic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 5 Jan 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.
Objective of the study:
- To determine changes in physical and cognitive function in patients with chronic stroke over 5 years
- To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study: Validity and Test-Retest Reliability of a Thai Stroke Physical Activity Questionnaire) which the population was stroke patients, aged ≥ 18 years with onset > 3 months. The study population is composed of patients who have achieved a compliance rate of more than 70% with the accelerometer within 1 week, total 50 people.
Key inclusion criteria (1 listed)
- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 6 minute walk testAlso: 10 meters walk test, Thai MMSETest for physical functions and cognitive functions | Diagnostic test | – |
Primary outcome
6-minute walk test
Time frame: 5 years
walk distance covered over a time of 6 minutes
10-meter walk test
Time frame: 5 years
comfortable \& fast gait speed
Thai MMSE
Time frame: 5 years
test patient's cognition with mini-mental state examination (MMSE) Minimum score = 0 (worst outcome, poor cognitive function) Maximum score = 30 (better outcome, good cognitive function)
4 secondary outcomes
Global quality of life
Time frame: 5 years
Short FES-I
Time frame: 5 years
Fatigue assessment scale
Time frame: 5 years
Barthel index
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stroke, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 5 years). The study lists 3 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 8 Oct 2024.