Moyamoya DiseaseNCT07144930
Cognitive-Motor Incorporated Training and Its Relations in Cerebrovascular Diseases With Cognitive and Motor Impairments
A study testing MCIT program and Motor training program in people with Moyamoya Disease and Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease, Healthy, Stroke
- What is being tested?
- MCIT program and Motor training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jun 2025to 31 Aug 2028
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For aged-matched healthy controls:
- being 20 years of age or older
- the ability to stand for more than 30 seconds
- a MoCA score of higher than 26.
- For PSCI participants:
- Diagnosis of stroke confirmed by brain CT or MRI, with symptom onset more than 7 days prior (subacute or chronic phase)
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- Being 20 years of age or older
- The ability to stand for more than 30 seconds
- a MoCA score of less than 26
- For the MMD group:
- a confirmed diagnosis of Moyamoya disease or Moyamoya syndrome through CT scan or angiography
- If stroke occurred, being in the subacute phase (one week post-stroke)
- being 20 years of age or older
- the ability to stand for more than 30 seconds
- a MoCA score of less than 26
- Diagnosis of stroke confirmed by brain CT or MRI, with symptom onset more than 7 days prior (subacute or chronic phase)
- Being 20 years of age or older
- The ability to stand for more than 30 seconds
- a MoCA score of less than 26
- Moyamoya disease/syndrome confirmed through CT scan or angiography
- being in the subacute phase, defined as one week after stroke onset
- being 20 years of age or older
- the ability to stand for more than 30 seconds
- a Montreal Cognitive Assessment (MoCA) score of less than 26.
Who cannot join
- unstable or uncontrolled vital signs, including a resting heart rate >100 or <40 BPM, a respiratory rate >20 or <12 breaths per minute, an SpO2 < 95%, a central arterial pressure (CAP) <80 mmHg, and individuals requiring ICP monitoring will also be excluded
- requiring invasive mechanical ventilation or being deemed unsuitable by the attending physician due to unstable medical conditions
- the presence of other neurological disorders or unstable vital signs may interfere with the experiment
- currently hospitalized in the intensive care unit (ICU)
- Severe visual or hearing impairments, or communication and comprehension difficulties that interfere with study participation
- Part 2:
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- unstable or uncontrolled vital signs, including a resting heart rate >100 or <40 BPM, a respiratory rate >20 or <12 breaths per minute, an SpO2 < 95%, a central arterial pressure (CAP) <80 mmHg, and individuals requiring ICP monitoring will also be excluded
- requiring invasive mechanical ventilation or being deemed unsuitable by the attending physician due to unstable medical conditions
- the presence of other neurological disorders or unstable vital signs may interfere with the experiment
- currently hospitalized in the intensive care unit (ICU)
- Severe visual or hearing impairments, or communication and comprehension difficulties that interfere with study participation
- Part 3:
- unstable or uncontrolled vital signs, including a resting heart rate >100 or <40 BPM, a respiratory rate >20 or <12 breaths per minute, an SpO2 < 95%, a central arterial pressure (CAP) <80 mmHg, and individuals requiring ICP monitoring will also be excluded
- requiring invasive mechanical ventilation or being deemed unsuitable by the attending physician due to unstable medical conditions
- the presence of other neurological disorders or unstable vital signs that could interfere with the experiment
- currently hospitalized in the intensive care unit (ICU)
- Severe visual or hearing impairments, or communication and comprehension difficulties that interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Yan Ci Liu, +886233668135, yanciliu@ntu.edu.tw
About this study
Official title: Impact of Cognitive-Motor Incorporated Training and Brain Activation Patterns in Cerebrovascular Diseases With Cognitive and Motor Impairments: Post Stroke Cognitive Impairment and Moyamoya Disease
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.
- Conditions
- Moyamoya Disease, Healthy, Stroke
- Being tested
- MCIT program, Motor training program
- Keywords
- Stroke, Motor-cognitive incorporated training, Cognitive function, Motor function, Post-stroke cognitive impairment
- Medical subject headings
- Moyamoya Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCIT programOther
The MCIT program combines motor and cognitive training, progressing independently with increasing difficulty.
- Motor training, 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.
- Cognitive incorporative component, adapted from previous stroke studies, supports cognitive recovery and overall well-being. Training starts with attention and short-term memory tasks, advancing to working memory and inhibitory control with increasing difficulty. Progression requires an 80% success rate; if not achieved, tasks are simplified by reducing memory span or providing additional guidance.
Motor training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MCIT program |
| 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. Receives: Other: Motor training program |
| 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. Receives: Other: MCIT program |
| 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. Receives: Other: Motor training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part 2, 3: 1-year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start23 Jun 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Ci Liu, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144930
- Sponsor's protocol ID
- 202502047RINA
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cognitive-Motor Incorporated Training and Brain Activation Patterns in Cerebrovascular Diseases With Cognitive and Motor Impairments: Post Stroke Cognitive Impairment and Moyamoya Disease
- ClinicalTrials.gov ID
- NCT07144930
- Acronym / sponsor ID
- 202502047RINA
- Conditions
- Moyamoya Disease, Healthy, Stroke
- Keywords
- Stroke, Motor-cognitive incorporated training, Cognitive function, Motor function, Post-stroke cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Aug 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MCIT programYear 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. |
| Post-stroke cognitive impairment with motor training program | Active comparator | Other: Motor training programYear 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. |
| Moyamoya Disease with MCIT program | Experimental | Other: MCIT programYear 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. |
| Moyamoya Disease with motor training program | Active comparator | Other: Motor training programYear 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- For aged-matched healthy controls:
- For PSCI participants:
- For the MMD group:
- Diagnosis of stroke confirmed by brain CT or MRI, with symptom onset more than 7 days prior (subacute or chronic phase)
- Being 20 years of age or older
Key exclusion criteria (17 listed)
- unstable or uncontrolled vital signs, including a resting heart rate >100 or <40 BPM, a respiratory rate >20 or <12 breaths per minute, an SpO2 < 95%, a central arterial pressure (CAP) <80 mmHg, and individuals requiring ICP monitoring will also be excluded
- requiring invasive mechanical ventilation or being deemed unsuitable by the attending physician due to unstable medical conditions
- the presence of other neurological disorders or unstable vital signs may interfere with the experiment
- currently hospitalized in the intensive care unit (ICU)
- Severe visual or hearing impairments, or communication and comprehension difficulties that interfere with study participation
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 |
|---|---|---|
| MCIT programThe MCIT program combines motor and cognitive training, progressing independently with increasing difficulty. * Motor training, 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. * Cognitive incorporative component, adapted from previous stroke studies, supports cognitive recovery and overall well-being. Training starts with attention and short-term memory tasks, advancing to working memory and inhibitory control with increasing difficulty. Progression requires an 80% success rate; if not achieved, tasks are simplified by reducing memory span or providing additional guidance. | Other | Moyamoya Disease with MCIT program, Post-stroke cognitive impairment with MCIT program |
| Motor training programBased 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. | Other | Moyamoya Disease with motor training program, Post-stroke cognitive impairment with motor training program |
Primary outcome
Global Cognitive Function
Time frame: 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)
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.
Task Switching
Time frame: 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)
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.
Inhibition Control
Time frame: 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)
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.
Working Memory
Time frame: 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)
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.
Cognitive Flexibility
Time frame: 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 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.
Sensorimotor Function
Time frame: 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 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.
Muscle Strength
Time frame: 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)
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.
Ambulation Ability
Time frame: 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 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.
Dual-Task Cost (DTC)
Time frame: 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) 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.
9 secondary outcomes
Oxyhemoglobin [HbO]
Time frame: 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]
Time frame: 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]
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Part 2, 3: 1-year post-intervention
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 28 Aug 2026.
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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.
Yan Ci Liu, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCIT program and Motor training program in people with Moyamoya Disease and Healthy, run by National Taiwan University Hospital at 1 site 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 24 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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 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?
Contact Yan Ci Liu, PhD (+886233668135, yanciliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Function (time frame: 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)). The study lists 9 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 28 Aug 2026.