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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 at
• Другое 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.

Первичные конечные точки

• Global Cognitive Function [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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)]

Вторичные конечные точки (9)

• Oxyhemoglobin [HbO] [Срок оценки: 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] [Срок оценки: 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] [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Part 2, 3: 1-year post-intervention]

Критерии участия

Part 1:

Критерии включения

• 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)
• 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

Критерии исключения

• 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:

Критерии включения

• 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

Критерии исключения

• 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:

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University — Taipei

Идентификаторы

NCT: NCT07144930 · 202502047RINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗