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

NCT07588997 | Recruiting

• 1 other identifier: 202508051RIN
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subarachnoid Aneurysm Hemorrhage

Keywords

Spontaneous subarachnoid hemorrhage; post-stroke cognitive impairment; motor-cognitive integrative training

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Kinematics performance

  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

  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)

Study Arms (2)

Early motor-cognitive integrative training (e-MCIT)

EXPERIMENTAL

Other: early motor-cognitive integrated training (e-MCIT)

Early mobilization group

ACTIVE COMPARATOR

Other: Early mobilization

Interventions

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

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 motor-cognitive integrative training (e-MCIT)

Early mobilization OTHER

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.

Early mobilization group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, 100, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 34132448 BACKGROUND

• 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.

  PMID: 34840972 BACKGROUND

• Kuliński, W. and K. Szymczyk, Physical Therapy in Patients After Subarachnoid Haemorrhage. Clinical and Social Study. Acta Balneologica, 2021. 163(1).

  BACKGROUND

• 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.

  PMID: 33354457 BACKGROUND

• 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.

  PMID: 37125534 BACKGROUND

• 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.

  PMID: 27058204 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Yan-ci Liu

CONTACT

+886 33668135; yanciliu@ntu.edu.tw

Po-min Hsu

CONTACT

+886 0932032382; min032382@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: May 15, 2026
• Study Start: November 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)