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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-100
SponsorNational Taiwan University Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

being 20 years of age or older

the ability to stand for more than 30 seconds

a MoCA score of higher than 26.

Diagnosis of stroke confirmed by brain CT or MRI, with symptom onset more than 7 days prior (subacute or chronic phase)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MCIT program

    Other intervention

    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

    Other intervention

    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.

Treatment groups

210 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: No Intervention: Healthy adultsNo intervention 0 interventions
Group B: Individuals with post-stroke cognitive impairmentNo intervention 0 interventions
Group C: Individuals with Moyamoya DiseaseNo intervention 0 interventions
Group D: Post-stroke cognitive impairment with MCIT programExperimental treatment 1 intervention
Group E: Post-stroke cognitive impairment with motor training programActive comparator 1 intervention
Group F: Moyamoya Disease with MCIT programExperimental treatment 1 intervention
Group G: Moyamoya Disease with motor training programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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)
2

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.

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)
3

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.

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)
4

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.

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)

Secondary outcomes

1

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.

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)
2

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.

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)
3

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.

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)
4

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.

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)

Other outcomes

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