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The following three-part proposal will explore the impact of applying motor-cognitive incorporated training (MCIT) in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD), and examine the relationship between cognitive and motor impairments and brain activation patterns in these populations.
Part I is a cross-sectional study designed to characterize cognitive and motor performance and their relationship with brain activation patterns in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD), compared to age-matched healthy controls. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests. Cognitive function tests include tests of global cognition, and executive function. Motor function tests include tests of sensorimotor function, single and dual task standing, muscle strength, and ambulation ability. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the cognitive tests, and single and dual task standing. Results from all tests will be used to determine the motor, cognitive, and other functional performance, and will be used in the design of the training program in Part II and III.
Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a motor-cognitive incorporated training (MCIT) on motor, and cognitive function in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD). 60 individuals with PSCI (Part II), and 60 individuals with MMD (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor and cognitive tests used in Part I, stroke location, and time of onset will also be collected for each participant. Brain activation will be assessed during the cognitive tests, single and dual task standing assessments using fNIRS. Participants will be randomly allocated to one of the two groups (MCIT group and active control group) (n=30 in each group) via a sealed envelope selected by a blinded assistant. The training protocol is 30 minutes per session, 3 sessions per week for a total of 4 weeks. The control group will receive motor training only, including upper and lower extremity exercises, bed mobility, strengthening (core and extremities), and balance training, progressing from static to dynamic tasks. The MCIT group will engage in the program combines motor and cognitive training that starts with attention and short-term memory tasks, advancing to working memory and inhibitory control with increasing difficulty. A post-test will be conducted after the 4-week intervention, followed by follow-up assessments at 1, 3, and 12 months for individuals with PSCI or MMD in both the control group and the MCIT group. At the 3-month follow-up, participants who are unable to attend in person will be contacted by telephone. At the 12-month follow-up, all participants will receive a telephone interview focused on return-to-work status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention: Healthy adults | No Intervention | Year 1: To characterize cognitive and motor performance and its relationship with brain activation patterns in individuals with post-stroke cognitive impairment (PSCI) and Moyamoya Disease (MMD). | |
| Individuals with post-stroke cognitive impairment | No Intervention | Year 1: To characterize cognitive and motor performance and its relationship with brain activation patterns in individuals with post-stroke cognitive impairment (PSCI) and Moyamoya Disease (MMD). | |
| Individuals with Moyamoya Disease | No Intervention | Year 1: To characterize cognitive and motor performance and its relationship with brain activation patterns in individuals with post-stroke cognitive impairment (PSCI) and Moyamoya Disease (MMD). | |
| Post-stroke cognitive impairment with MCIT program | Experimental | Year 2-3: To evaluate the short- and long-term efficacy of Motor-Cognitive Incorporated Training (MCIT) in improving cognitive and motor outcomes and modulating brain activation patterns in PSCI individuals. |
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| Post-stroke cognitive impairment with motor training program | Active Comparator | Year 2-3: To evaluate the short- and long-term efficacy of Motor-Cognitive Incorporated Training (MCIT) in improving cognitive and motor outcomes and modulating brain activation patterns in PSCI individuals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCIT program | Other | The MCIT program combines motor and cognitive training, progressing independently with increasing difficulty.
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Cognitive Function | Global cognitive function will be assessed using the Taiwan 7.1 version of the Montreal Cognitive Assessment (MoCA). The test includes 16 items and 11 categories, evaluating multiple cognitive domains. It has been validated in various clinical populations and countries. Scores range from 0 to 30, higher scores indicate better performance. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Task Switching | The Trail Making Test-A (TMT-A) requires participants to sequentially connect 25 numbered dots, while the Chinese version of TMT-B involves alternating between numbers (1-12) and Chinese zodiac signs (rat to pig). The Chinese TMT-B is a reliable tool for assessing executive function in older adults. Completion time (lower is better) is the primary outcome, with error rates also recorded. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Inhibition Control | The Chinese version of Stroop Color and Word Test (SCWT) consists of two parts: (1) a congruent condition, where participants read color-words printed in matching ink, and (2) an incongruent condition, where they identify the ink color of mismatched color-words (e.g., "black" printed in blue). Participants execute 45 seconds per task, and scores are based on the number of correct responses. Higher scores indicate better performance. The Chinese SCWT is a reliable EF assessment for older adults. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Working Memory | Digit Span Test (DS) consists of 8 items with 2 trials each, starting with 2-digit sequences and increasing to 9 digits. Participants repeat the digits in the order presented, scoring 1 point per correct response. Testing ends when both trials for an item are incorrect. Scores range from 0 to 16, with higher scores indicating better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxyhemoglobin [HbO] | Oxyhemoglobin [HbO] will be measured using a multichannel wearable Functional Near-Infrared Spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NYC, USA), which emits and receives dual-wavelength near-infrared signals at 760 and 850 nm. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
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Part 1:
Inclusion Criteria:
For aged-matched healthy controls:
For PSCI participants:
For the MMD group:
Exclusion Criteria:
Part 2:
Inclusion Criteria:
Exclusion Criteria:
Part 3:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Ci Liu, PhD | Contact | +886233668135 | yanciliu@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yan Ci Liu, PhD | National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D009072 | Moyamoya Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Moyamoya Disease with MCIT program | Experimental | Year 2-3: To evaluate the short- and long-term efficacy of MCIT in improving cognitive and motor outcomes and modulating brain activation patterns in MMD individuals. |
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| Moyamoya Disease with motor training program | Active Comparator | Year 2-3: To evaluate the short- and long-term efficacy of MCIT in improving cognitive and motor outcomes and modulating brain activation patterns in MMD individuals. |
|
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| Motor training program | Other | Based on traditional physical therapy for stroke patients, includes upper and lower extremity exercises, bed mobility, strengthening (core and extremities), and balance training, progressing from static to dynamic tasks. Progression is guided by core action goals (Table 2) and depends on stable vital signs, balance, and minimal assistance. If participants are unable to progress, simpler tasks are provided. |
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| Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Cognitive Flexibility | Cognitive flexibility was evaluated using a Naming test. Participants name items within specific categories (fruits, vegetables, modes of transportation). They are given 1 minute to list as many items as possible from a single category, and the total number of correct responses is recorded. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Sensorimotor Function | Sensorimotor function after stroke will be measured by Fugl-Meyer Assessment for upper extremity (FMA-UE) and lower extremity (FMA-LE). The FMA-UE includes subtests evaluating the upper extremity, wrist, hand, and coordination/speed, with scores ranging from 0 to 66. The FMA-LE comprises 17 items that measure reflexes, movement, and coordination of the lower extremity, scored on a 3-point ordinal scale (0-2), with a total score of 34 points. Higher scores indicate better motor recovery. The validity and reliability of both assessments are well established. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Muscle Strength | Bilateral muscle strength of the shoulder flexors, elbow flexors, wrist extensors, ankle flexors/extensors, knee flexors/extensors, hip flexors/extensors, and hip abductors will be measured using a wireless handheld dynamometer (microFET2, Hoggan Industries, Inc., West Jordan, UT, USA). Each muscle group will be tested twice, with participants performing maximal contractions for 6 seconds per trial. A 30-second rest period will be provided between trials to prevent fatigue. The average of the two maximal efforts will be recorded. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Ambulation Ability | Ambulation ability will be evaluated using the Functional Ambulatory Category (FAC), a 6-level scale (0-5). Level 0 indicates the inability to walk, while level 5 represents complete independence. Intermediate levels reflect varying degrees of required assistance or supervision. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Dual-Task Cost (DTC) | Dual-task cost (DTC) will be calculated to perform the difference between single-task and dual-task condition, expressed as a percentage. The DTC will be calculated as: (Dual task measure - Single task measure) / Single task measure x 100%. For the single task, participants will stand still with a feet-together standing posture for 30 seconds, while for the dual task, they will continuously subtract 1 from a random 2-digit number while maintaining standing posture. Each condition will include a 1-minute rest period and will be repeated for three trials to ensure consistency. During the single and dual tasking, kinematic performance will be assessed using the 95% ellipse sway area and RMS sway, recorded by 3 wearable inertial sensors (APDM Mobility Lab® Opal system) placed bilaterally at the ankles and at the 5th lumbar vertebra. Postural sway analysis will include angle (degrees), mean velocity, acceleration, and jerk of the sway trajectory. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Deoxyhemoglobin [HbR] | Deoxyhemoglobin [HbR] will be measured using a multichannel wearable Functional Near-Infrared Spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NYC, USA), which emits and receives dual-wavelength near-infrared signals at 760 and 850 nm. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Hemoglobin difference levels [Hbdiff] | Hemoglobin difference levels (Hbdiff) will be measured using a multichannel wearable Functional Near-Infrared Spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NYC, USA), which emits and receives dual-wavelength near-infrared signals at 760 and 850 nm. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Activity of daily living (ADL) | The Modified Rankin Scale (mRS) assesses disability levels in ADL, ranging from 0 (no symptoms) to 6 (death). Scores between 1 and 5 reflect increasing levels of disability, from slight (independent) to severe (bedridden), with higher scores indicating lower functional ability. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Functional Independence | The Functional Independence Measure (FIM) will be used to evaluate subjects' ADL abilities. The FIM includes 18 motor and cognitive items, with total scores ranging from 18 to 126. Higher scores indicate greater independence. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Instrumental activity of daily living (IADL) | The Instrumental Activity of Daily Living (IADL) scale evaluates independence across eight domains: telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial handling. Scores range from 0 (lowest independence) to 8 (highest independence), with higher scores indicating greater functional ability. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Depression | Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), specifically the depression subscale. Scores of 8-10 indicate mild depression, 11-14 moderate, and 15-21 severe, with higher scores reflecting greater depressive symptoms. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Quality of life (QoL) | Quality of Life will be measured using the 36-item Short Form Health Survey (SF-36). The validated Taiwanese version will be used, which has strong psychometric properties. Higher scores indicate better health-related quality of life. | Part 1: Baseline (Week 0); Part 2, 3: Baseline (Week 0), immediately post-intervention (Week 5), 4 weeks post-intervention (Week 9), and 12 weeks post-intervention (Week 17) |
| Return to work | To track whether participants are able to return to work or re-enter their occupational environment, a telephone interview will be conducted at the 1-year follow-up. If a participant is able to return to work but requires adjustments to their job role or a change in occupation, this information will be documented in detailed notes. | Part 2, 3: 1-year post-intervention |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |