Cognitive-Motor Incorporated Training and Its Relations in Cerebrovascular Diseases With Cognitive and Motor Impairments

Condition(s) studied

Investigational drug(s) / intervention(s)

MCIT program: 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 program: 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 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 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.

Eligibility

Primary outcome measure(s)

• Global Cognitive Function — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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.

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