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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Aneurysm Hemorrhage
• Intervention / Treatment: Other: early motor-cognitive integrated training (e-MCIT); Other: Early mobilization

Detailed Description

Spontaneous subarachnoid hemorrhage (SAH), often resulting from intracerebral aneurysm rupture is a relatively uncommon but impactful form of stroke predominantly affecting middle-aged individuals. Aneurysmal SAH (aSAH) presents a high risk of post-stroke cognitive impairment (PSCI) compared to other stroke types, with an occurrence rate ranging from 26% to 43%. Cognitive impairments, particularly in executive function, attention, memory, and language abilities, are prevalent among aSAH survivors, with notable differences observed in cognitive outcomes based on medical interventions such as clipping or coiling. Additionally, cerebral changes following aSAH, including delayed onset cerebral infraction, white matter hyperintensities and focal encephalomalacia, contribute to cognitive deficits. In clinical settings, patients with aSAH often demonstrate notable improvements in motor function recovery, however, cognitive issues, such as executive function and complex attention, are closely linked to patients' inability to perform the activities of daily living (ADL) independently and return to work, even after disease recovery. While physical therapy interventions, including early mobilization, show promise in enhancing functional outcomes, there is a dearth of research specifically addressing cognitive rehabilitation in aSAH patients. Integration of motor-cognitive training approaches, such as motor-cognitive integrative training (MCIT), may hold potential for improving cognitive and motor recovery in SAH patients, akin to their application in other neurological disorders like Parkinson's disease and stroke. Understanding the intricate relationship between cognitive deficits and functional outcomes is crucial for developing targeted rehabilitation strategies to improve the quality of life for aSAH survivors.

The present study aims to examine the impact of early intervention with MCIT (e-MCIT) on cognitive function, motor recovery, functional abilities, and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment. Additionally, we investigate whether SAH patients who receive e-MCIT achieve better long-term workplace reintegration.

This is a randomized, controlled, assessor-blinded clinical trial. The intervention commences during the acute setting in the ICU period and extends through the subacute phase in the hospital's general ward. Evaluation will be conducted at five assessment time points including baseline assessment (following initial medical intervention), assessment at the time of discharge from the intensive care center (ICU), discharge from the hospital, 3-month follow up and 1-year follow up. After recruiting in this study, participants will be randomized into traditional group (early mobilization group) or e-MCIT group.

Eighteen patients with aSAH will be recruited, which Inclusion criteria for enrolment are as follows: (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. Patients who present unstable vital sign (e.g., heart rate (HR): 40-100bpm, mean arterial pressure (MAP)> 80mmHg, respiratory rate (RR): 12-20, oxygen saturation (SpO2) > 95%, intracranial pressure (ICP) < 20mmHg and cerebral perfusion pressure (CPP) > 70mmHg) according to the criteria in previous study[1] or evaluated as unsuitable by their attending physician will be excluded. Participants who are with other neurological disease might interfere the experiment and their education years less than 12 years will be excluded in this study.

Early motor-cognitive integrative training (e-MCIT) is an approach where motor and cognitive training are conducted simultaneously. Traditional group receive the same motor-only program in e-MCIT. The intervention consists of 30-minute sessions, conducted 4-5 times per week, until discharging from the hospital.

Outcome measurements includes side-effect events record, Montreal Cognitive Assessment (MoCA), Trail Making Test part A(TMT-A), Trail Making Test part B(TMT-B), Stroop color and word test (SCWT), digit span (DS) test, Go and no-go (GNG) test, Verbal Fluency test (VFT), Fugl-Meyer Assessment for upper extremity (FMA-UE) and lower extremity (FMA-LE), Medical Research Council (MRC), Functional ambulatory category (FAC), kinematics performance in single and dual task ability, brain activity by functional Near-Infrared Spectroscopy (fNIRS) during all cognition assessment and in single and dual task, Functional independence measure (FIM), Modified Rankin Scale (mRS), Perme ICU mobility score, and National Institutes of Health Stroke Scale (NIHSS), Instrumental Activity of Daily Living scale, Hospital anxiety and depression scale (HADS), 36-item short form health survey (SF-36) and 1-year follow-up telephone interview .

Statistical analysis was conducted using SPSS version 26.0. Categorical variables in the descriptive data of the participants were presented as numbers and percentages, while continuous variables were expressed as mean ± standard deviation. Nominal variables would be analyzed by X2 test. Analyzed using either a two-way ANOVA or Wilcoxon Signed-Rank Test will be used to test the differences between pre-test and post-intervention time points due to small sample size. A two-tailed significance level (α) was set at 0.05. Thus, p< 0.05 revealed significant difference.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan-ci Liu; Phone Number: +886 33668135; Email: yanciliu@ntu.edu.tw
• Study Contact Backup: Name: Po-min Hsu; Phone Number: +886 0932032382; Email: min032382@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
    • Contact: Hsu; Phone Number: +886 932032382; Email: min032382@gmail.com
    • Contact: Liu; Phone Number: +886 33668135

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early motor-cognitive integrative training (e-MCIT)	Other: early motor-cognitive integrated training (e-MCIT); 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.
Active Comparator: Early mobilization group	Other: Early mobilization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Montreal Cognitive Assessment (MoCA)	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Trail Making Test part A(TMT-A) and Trail Making Test part B(TMT-B)	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Stroop color and word test (SCWT)	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
digit span (DS) test	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Go and no-go (GNG) test	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Verbal fluency test (VFT)	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Fugl-Meyer Assessment for upper extremity (FMA-UE) and lower extremity (FMA-LE)	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Medical Research Council (MRC) scale	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Functional ambulatory category (FAC)	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
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	T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks), T3(3-month follow up)
Functional independence measure (FIM)		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).
Modified Rankin Scale (mRS)		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).
Perme ICU mobility score		T0(baseline), T1(discharge from ICU, an average of 2 weeks)
National Institutes of Health Stroke Scale (NIHSS)		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).
Instrumental Activity of Daily Living scale		T2(discharge from hospital, an average of 4weeks), T3(3-month follow up) and T4(1-year follow up).
Hospital anxiety and depression scale (HADS)		T2(discharge from hospital, an average of 4weeks), T3(3-month follow up) and T4(1-year follow up).
36-item short form health survey (SF-36)		T2(discharge from hospital, an average of 4weeks), T3(3-month follow up) and T4(1-year follow up).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.
• Sun R, Li X, Zhu Z, Li T, Li W, Huang P, Gong W. Effects of Combined Cognitive and Exercise Interventions on Poststroke Cognitive Function: A Systematic Review and Meta-Analysis. Biomed Res Int. 2021 Nov 17;2021:4558279. doi: 10.1155/2021/4558279. eCollection 2021.
• Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.
• Xuefang L, Guihua W, Fengru M. The effect of early cognitive training and rehabilitation for patients with cognitive dysfunction in stroke. Int J Methods Psychiatr Res. 2021 Sep;30(3):e1882. doi: 10.1002/mpr.1882. Epub 2021 Jun 15.
• Kuliński, W. and K. Szymczyk, Physical Therapy in Patients After Subarachnoid Haemorrhage. Clinical and Social Study. Acta Balneologica, 2021. 163(1).
• Alfonso M, Aftab S, Hamadneh T, Sherali N, Tsouklidis N. Understanding Cognitive Deficit After Subarachnoid Hemorrhage: A Memory Focused Approach. Cureus. 2020 Nov 16;12(11):e11513. doi: 10.7759/cureus.11513.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 17, 2025
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: post-stroke cognitive impairment; Spontaneous subarachnoid hemorrhage; motor-cognitive integrative training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Early Ambulation
• Other Study ID Numbers: 202508051RIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No