Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

Despite its lower incidence rate within the stroke population and tendency to affect younger individuals, SAH carries the highest risk of PSCI. The neural mechanisms underlying these cognitive deficits remain poorly understood, but potential factors include treatment approaches, underlying disease pathophysiology, post-disease complications, or alterations in neural connectivity\[10\]. Previous literature indicates that cognitive deficits in SAH primarily manifest in areas such as visuospatial skill, verbal memory language abilities (including verbal comprehension, verbal fluency, abstract language), executive function (working memory) and attention. These impairments significantly impact patients' ability to perform ADL independently and return to work, despite motor function recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography. (2) Onset of stroke occurring in the acute phase, specifically 2-7 days after medical intervention. (3) Participants must be over 18 years old. (4) WFNS: 1-5. (5) Able to stand above 30 seconds. (6) Montreal Cognitive Assessment (MoCA)<26.

Disqualifiers

(1)unstable vital sign. (2)patients evaluated as unsuitable by their attending physician. (3)those with other neurological diseases that might interfere with the experiment. (4)less than 12 years of education will be excluded from this study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • early motor-cognitive integrated training (e-MCIT)

    Other intervention

    Early motor-cognitive integrative training (e-MCIT) is an approach where motor and cognitive training are conducted simultaneously (illustrated in Table 1). The intervention consists of 30-minute sessions, conducted 4-5 times per week, until discharging from the hospital. Both motor and cognitive training have five stages each, and their progression is independent, meaning that during training, a participant might be in the fourth stage of motor training and the second stage of cognitive training. According to hospital's policy, occupational therapy and speech therapy will be provided in schedule if needed.

  • Early mobilization

    Other intervention

    It progresses through various stages, including raising the head of the bed, sitting up, standing, transferring to a wheelchair, marching in place, and walking. Additionally, the training includes general rehabilitation activities such as range of motion exercises, bed exercises, strengthening exercise, balance training and motor facilitation. To regulate appropriate training, range of motion exercises begin with passive range of motion (PROM) exercises and progress to assisted-active range of motion (AAROM) and active range of motion (AROM) exercises gradually according to the participant's ability to follow instructions. These exercises include all upper and lower extremities. Bed exercises consist of mat exercises, which focus on the lower extremities and core muscles, and bed mobility training.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Early motor-cognitive integrative training (e-MCIT)Experimental treatment 1 intervention
Group B: Early mobilization groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessment (MoCA)

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
2

Trail Making Test part A(TMT-A) and Trail Making Test part B(TMT-B)

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
3

Stroop color and word test (SCWT)

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
4

digit span (DS) test

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)

Secondary outcomes

1

Kinematics performance

postural sway, including parameters such as 95% ellipse sway area, RMS sway. All data was recorded by wearable inertial sensors (APDM Mobility Lab® Opal inertial sensor system).

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
2

Brain activity

multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NYC, USA). Exports and receives dual-wavelength near-infrared signals are 760 and 850 nm. Data collection includes measurement changes in oxyhemoglobin \[HbO\], de-oxyhemoglobin \[HbR\] and the difference between HbO and HbR

Time frame
T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
3

Functional independence measure (FIM)

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up) and T4(1-year follow up).
4

Modified Rankin Scale (mRS)

Time frame
T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up) and T4(1-year follow up).

Other outcomes

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