StrokeNCT03792061
Enhancing Community Participation for Stroke Survivors With Cognitive Impairments
A study testing Strategy Training in people with Stroke and Cognitive Impairment, run by Taipei Medical University at 4 sites in Taiwan.
Trial summary
Abstract Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Cognitive Impairment
- What is being tested?
- Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesTaiwan
- Study dates
- 13 Jan 2019to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 20 years and older
- Has a diagnosis of stroke
- Understand Mandarin
- Has cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version)
- Provide informed consent
Who cannot join
- Have severe aphasia
- Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taipei Medical University-Shuang Ho Hospital
New Taipei City
National Taiwan University Hospital
Taipei
Taipei Medical University
Taipei
Taipei Municipal Wan Fang Hospital
Taipei
About this study
Official title: Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke
Abstract
Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Each session will be around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions.
Read more
Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5).
Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear regression models and mixed-effects regression models.
Read the detailed description
The proposed study will examine the efficacy of a newly developed intervention program, the Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving participation in productivity, social activities, and community among community-dwelling people with cognitive impairments after stroke. The OPASS program were developed based on the theoretical tenets of strategy training, with the goal of helping participants to set their participation goals, identify barriers to their performance, develop strategies to address these barriers, and generalize their learning through iterative practice. To examine the efficacy of OPASS, the following objectives will be addressed in this study:
- To examine whether, compared to a control group, participating in the OPASS program will improve participation in productivity, social, and community domains in stroke survivors with cognitive impairments;
- To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.
- To examine whether the intervention effect sustains at 3-, 6-, and 12-month following the intervention.
To address this purpose, parallel-group randomized controlled trial will be implemented to assess the efficacy of the OPASS program in comparison to the control group. An expected sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient rehabilitation services will be recruited from our collaborative sites in Northern Taiwan. These participants will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio.
Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models. Of the recruited participants, 100 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline(T1), post-intervention(T2), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models.
Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.
- Conditions
- Stroke, Cognitive Impairment
- Being tested
- Strategy Training
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy TrainingBehavioural
This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Strategy Training | Experimental | Strategy training is an activity intervention training approach developed based on the theoretical tenets of metacognitive training. The purpose of strategy training is to guide individuals to generate problem-solving skills to address challenges that they identify in daily activities. Receives: Behavioral: Strategy Training |
| Reflective listening | No intervention | Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Measured: From baseline to 6-8 weeks (post-intervention)
Secondary outcomes (29)
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Measured: From baseline to up to 6-8 weeks (post-intervention)
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Measured: From baseline to 3-month follow-up
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Measured: From baseline to 6-month follow-up
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Measured: From baseline to 12-month follow-up
HEAL positive outlook questionnaire
he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.
Measured: From baseline to up to 6-8 weeks (post-intervention)
General self-efficacy Scale (GSES)
The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
Measured: From baseline to up to 6-8 weeks (post-intervention)
General self-efficacy Scale (GSES)
The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
Measured: From baseline to 3-month follow-up
General self-efficacy Scale (GSES)
The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
Measured: From baseline to 6-month follow-up
General self-efficacy Scale (GSES)
The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
Measured: From baseline to 12-month follow-up
Canadian Occupational Performance Measure (COPM)
The COPM inquires the client to identify important goals in their daily life and rate their performance and satisfaction for each goal on a 10-point visual analog scale.
Measured: From the first session to the last session of the study, up to 8 weeks
Stroop Test
Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
Measured: From baseline to up to 6-8 weeks (post-intervention)
Stroop Test
Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
Measured: From baseline to 3-month follow-up
Stroop Test
Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
Measured: From baseline to 6-month follow-up
Stroop Test
Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
Measured: From baseline to 12-month follow-up
Trail-Making Test (TMT A and B)
Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
Measured: From baseline to up to 6-8 weeks (post-intervention)
Trail-Making Test (TMT A and B)
Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
Measured: From baseline to 3-month follow-up
Trail-Making Test (TMT A and B)
Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
Measured: From baseline to 6-month follow-up
Trail-Making Test (TMT A and B)
Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
Measured: From baseline to 12-month follow-up
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Measured: From baseline to up to 6-8 weeks (post-intervention)
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Measured: From baseline to 3-month follow-up
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Measured: From baseline to 6-month follow-up
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Measured: From baseline to 12-month follow-up
The National Institutes of Health Stroke scale (NIHSS)
The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.
Measured: From baseline to 3-month, 6-month, and 12-month follow-ups
modified Rankin Scale (MRS)
The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.
Measured: From baseline to 3-month, 6-month, and 12-month follow-ups
Euro-QoL-5-Dimension (EQ-5D)
The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.
Measured: From baseline to 3-month, 6-month, and 12-month follow-ups
Qualitative data
Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected.
Measured: After intervention, an average of 2 months
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Measured: From baseline to 3-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Measured: From baseline to 6-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Measured: From baseline to 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start13 Jan 2019
- Primary completion22 Aug 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Medical 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Hang Chang, Taipei Medical University
- Investigators
- Feng-Hang Chang, ScD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792061
- Sponsor's protocol ID
- N201804055
- Status last verified
- Nov 2024
- First submitted
- 1 Jan 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD is not planned to be shared.
Publications
Hsu SP, Skidmore ER, Kang JH, Chiu V, Wu YH, Han DS, Liou TH, Lin YN, Chang FH. Effect of participation-focused strategy training on post-stroke cognitive functions and quality of life: results from a randomized trial. Ann Phys Rehabil Med. 2026 Jun;69(5):102116. doi: 10.1016/j.rehab.2026.102116. Epub 2026 Apr 20.
PubMed 42013638Hsu SP, Hung TH, Lin YN, Kang JH, Han DS, Chiu V, Liou TH, Wu YH, Ni PS, Skidmore ER, Chang FH. Enhancing Societal Participation for Stroke Survivors With Cognitive Impairments: A Randomized Controlled Trial. J Am Heart Assoc. 2025 Oct 7;14(19):e042295. doi: 10.1161/JAHA.125.042295. Epub 2025 Sep 19.
PubMed 40970531Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
PubMed 35349186Chang FH, Chiu V, Ni P, Lin YN, Kang JH, Liou TH, Lu L, Han DS, Skidmore ER. Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan. BMJ Open. 2020 Dec 7;10(12):e040241. doi: 10.1136/bmjopen-2020-040241.
PubMed 33293312
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke
- ClinicalTrials.gov ID
- NCT03792061
- Acronym / sponsor ID
- N201804055
- Conditions
- Stroke, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jan 2019 (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.
Abstract
Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Each session will be around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions.
Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5).
Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear regression models and mixed-effects regression models.
Detailed description
The proposed study will examine the efficacy of a newly developed intervention program, the Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving participation in productivity, social activities, and community among community-dwelling people with cognitive impairments after stroke. The OPASS program were developed based on the theoretical tenets of strategy training, with the goal of helping participants to set their participation goals, identify barriers to their performance, develop strategies to address these barriers, and generalize their learning through iterative practice. To examine the efficacy of OPASS, the following objectives will be addressed in this study:
- To examine whether, compared to a control group, participating in the OPASS program will improve participation in productivity, social, and community domains in stroke survivors with cognitive impairments;
- To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.
- To examine whether the intervention effect sustains at 3-, 6-, and 12-month following the intervention.
To address this purpose, parallel-group randomized controlled trial will be implemented to assess the efficacy of the OPASS program in comparison to the control group. An expected sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient rehabilitation services will be recruited from our collaborative sites in Northern Taiwan. These participants will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio.
Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models. Of the recruited participants, 100 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline(T1), post-intervention(T2), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models.
Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy Training | Experimental | Behavioral: Strategy TrainingStrategy training is an activity intervention training approach developed based on the theoretical tenets of metacognitive training. The purpose of strategy training is to guide individuals to generate problem-solving skills to address challenges that they identify in daily activities. |
| Reflective listening | No intervention | –Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 20 years and older
- Has a diagnosis of stroke
- Understand Mandarin
- Has cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version)
- Provide informed consent
Key exclusion criteria (2 listed)
- Have severe aphasia
- Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.
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 |
|---|---|---|
| Strategy TrainingThis approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life. | Behavioural | Strategy Training |
Primary outcome
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: From baseline to 6-8 weeks (post-intervention)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
29 secondary outcomes
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Time frame: From baseline to up to 6-8 weeks (post-intervention)
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Time frame: From baseline to 3-month follow-up
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Time frame: From baseline to 6-month follow-up
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Time frame: From baseline to 12-month follow-up
HEAL positive outlook questionnaire
Time frame: From baseline to up to 6-8 weeks (post-intervention)
General self-efficacy Scale (GSES)
Time frame: From baseline to up to 6-8 weeks (post-intervention)
General self-efficacy Scale (GSES)
Time frame: From baseline to 3-month follow-up
General self-efficacy Scale (GSES)
Time frame: From baseline to 6-month follow-up
General self-efficacy Scale (GSES)
Time frame: From baseline to 12-month follow-up
Canadian Occupational Performance Measure (COPM)
Time frame: From the first session to the last session of the study, up to 8 weeks
Stroop Test
Time frame: From baseline to up to 6-8 weeks (post-intervention)
Stroop Test
Time frame: From baseline to 3-month follow-up
Stroop Test
Time frame: From baseline to 6-month follow-up
Stroop Test
Time frame: From baseline to 12-month follow-up
Trail-Making Test (TMT A and B)
Time frame: From baseline to up to 6-8 weeks (post-intervention)
Trail-Making Test (TMT A and B)
Time frame: From baseline to 3-month follow-up
Trail-Making Test (TMT A and B)
Time frame: From baseline to 6-month follow-up
Trail-Making Test (TMT A and B)
Time frame: From baseline to 12-month follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to up to 6-8 weeks (post-intervention)
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to 3-month follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to 6-month follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to 12-month follow-up
The National Institutes of Health Stroke scale (NIHSS)
Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
modified Rankin Scale (MRS)
Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
Euro-QoL-5-Dimension (EQ-5D)
Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
Qualitative data
Time frame: After intervention, an average of 2 months
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: From baseline to 3-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: From baseline to 6-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: From baseline to 12-month 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 20 Nov 2024.
- Derived from this study: PubMed 42013638Hsu SP, Skidmore ER, Kang JH, Chiu V, Wu YH, Han DS, Liou TH, Lin YN, Chang FH. Effect of participation-focused strategy training on post-stroke cognitive functions and quality of life: results from a randomized trial. Ann Phys Rehabil Med. 2026 Jun;69(5):102116. doi: 10.1016/j.rehab.2026.102116. Epub 2026 Apr 20.
- Derived from this study: PubMed 40970531Hsu SP, Hung TH, Lin YN, Kang JH, Han DS, Chiu V, Liou TH, Wu YH, Ni PS, Skidmore ER, Chang FH. Enhancing Societal Participation for Stroke Survivors With Cognitive Impairments: A Randomized Controlled Trial. J Am Heart Assoc. 2025 Oct 7;14(19):e042295. doi: 10.1161/JAHA.125.042295. Epub 2025 Sep 19.
- Derived from this study: PubMed 35349186Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
- Derived from this study: PubMed 33293312Chang FH, Chiu V, Ni P, Lin YN, Kang JH, Liou TH, Lu L, Han DS, Skidmore ER. Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan. BMJ Open. 2020 Dec 7;10(12):e040241. doi: 10.1136/bmjopen-2020-040241.
- Individual participant dataSharing planned: No. The IPD is not planned to be shared.
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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.
Feng-Hang Chang, ScD principal investigator
Taipei Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy Training in people with Stroke and Cognitive Impairment, run by Taipei Medical University at 4 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D) (time frame: From baseline to 6-8 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792061, which also lists 4 linked publications.
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 20 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.