Stroke Clinical Trial
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. 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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University-Shuang Ho Hospital | New Taipei City | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Medical University | Taipei | |
Taiwan | Taipei Municipal Wan Fang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From baseline to up to 6 weeks | |
Secondary | 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. | From baseline to up to 6 weeks | |
Secondary | 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. | From baseline to 3-month follow-up | |
Secondary | 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. | From baseline to 6-month follow-up | |
Secondary | 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. | From baseline to 12-month follow-up | |
Secondary | HEAL positive outlook questionnaire | he HEAL positive outlook questionnaire will be used to assess participant's positive attitude. | From baseline to up to 6 weeks | |
Secondary | Participation Strategies self-efficacy Scale (PS-SES) | The PSSES 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. | From baseline to up to 6 weeks | |
Secondary | Participation Strategies self-efficacy Scale (PS-SES) | The PSSES 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. | From baseline to 3-month follow-up | |
Secondary | Participation Strategies self-efficacy Scale (PS-SES) | The PSSES 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. | From baseline to 6-month follow-up | |
Secondary | Participation Strategies self-efficacy Scale (PS-SES) | The PSSES 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. | From baseline to 12-month follow-up | |
Secondary | 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. | From the first session to the last session of the study, up to 8 weeks | |
Secondary | 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. | From baseline to up to 6 weeks | |
Secondary | 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. | From baseline to 3-month follow-up | |
Secondary | 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. | From baseline to 6-month follow-up | |
Secondary | 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. | From baseline to 12-month follow-up | |
Secondary | 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. | From baseline to up to 6 weeks | |
Secondary | 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. | From baseline to 3-month follow-up | |
Secondary | 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. | From baseline to 6-month follow-up | |
Secondary | 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. | From baseline to 12-month follow-up | |
Secondary | Montreal Cognitive Assessment (MoCA) | MoCA Test allows people to quickly assess a patients cognitive health. | From baseline to up to 6 weeks | |
Secondary | Montreal Cognitive Assessment (MoCA) | MoCA Test allows people to quickly assess a patients cognitive health. | From baseline to 3-month follow-up | |
Secondary | Montreal Cognitive Assessment (MoCA) | MoCA Test allows people to quickly assess a patients cognitive health. | From baseline to 6-month follow-up | |
Secondary | Montreal Cognitive Assessment (MoCA) | MoCA Test allows people to quickly assess a patients cognitive health. | From baseline to 12-month follow-up | |
Secondary | 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. | From baseline to 3-month, 6-month, and 12-month follow-ups | |
Secondary | modified Rankin Scale (MRS) | The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life. | From baseline to 3-month, 6-month, and 12-month follow-ups | |
Secondary | 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. | From baseline to 3-month, 6-month, and 12-month follow-ups | |
Secondary | 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. | After intervention, an average of 2 months | |
Secondary | 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. | From baseline to 3-month follow-up | |
Secondary | 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. | From baseline to 6-month follow-up | |
Secondary | 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. | From baseline to 12-month follow-up |
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