The Impact of Non-motor Symptom on the Outcome of Stroke Subjects

NCT06854497 | Active Not Recruiting

• 2 other identifiers: CYCH2765041R112-03
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The most common symptoms of stroke were focal weakness, hemiparesis, speech disturbance, diplopia and ataxia. Beside those symptoms, there are still many symptoms occurring after stroke, which may affect the life quality of participants. Compared to motor symptoms, the study of these non-motor symptoms was too small. At present, the most reported non-motor symptoms after stroke are sleep disorder, depression and post-stroke pain. There are still many symptoms that were not investigated. The study investigates the prevalence of non-motor syndromes in acute ischemic stroke patients and the impact of these syndromes on the outcome of ischemic stroke patients. The non-motor syndromes that were researched include dizziness, pain, skin lesions, sensory impairment, fever, infection, delirium, depression, insomnia, confusion, delirium and headache. Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who hospitalized to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as the feeling drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The study investigates the prevalence and impact of fatigue on stroke populations' outcomes. In depression, a person experiences a loss of pleasure or interest in activities and feels sad, irritable, and empty. Post-stroke depression is common. When a stroke person has a depressed mood, they may have no motivation for activity. This may interfere with physical therapy and affect the outcome of a stroke. The study investigates post-stroke depression prevalence and impact. The study investigates the prevalence and impact of sleep apnea on stroke outcome.

Conditions

Delirium; Fatigue; Depression; Insomnia; Sleep Apnea Syndrome (OSAS); Skin Lesion; Dementia

Keywords

skin lesion; stroke; delirium; fatigue; sleep disorder; depression; outcomes

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  Modified Rankin Score (mRS) is used to evaluate the functional outcome of the participants up to 3 months after stroke onset. The mRS score (0 to 6), scores of 0-3 indicate mild to moderate disability. a score of 4-5 indicates severe disability, and 6 indicates death. In the study, a mRS over 2 is considered poor outcome.

  Participants are followed-up up to 3 months after stroke onset.

Secondary Outcomes (1)

• Quality of life in ischemic stroke patients

  follow patient daily activity of life at 3 month after stroke

Interventions

MMSE (Mini-Mental State Examination),NIHSS (NIH Stroke Scale) and mRS (Mordified Rankin Score), Confusion Assessment Methods (CAM), PSQI Pittsburgh Sleep Quality Index, Respiratory polygraphy DIAGNOSTIC_TEST

Respiratory polygraphy will be performed during acute stroke period, to evaluate the relationship between sleep apnea and stroke evolution.

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients admitted to hospital within 1 week of stroke onset. Brain magnetic resonance inaging confirmed ischemic. Patient age between 20 and 90 years old were included the study. Exclusion criteria were 1. patient older than 90 years old. 2. patient cannot communication included severe dementia, aphasia and consciousness disturbance. 3. Patient do not agree participate the study.

You may qualify if:

• \. Acute stroke within 1 week.
• \. Ischemic stroke was confirmed by magnetic resonance imaging.

You may not qualify if:

• \. Patient not agree the study.
• \. Patient cannot communication.
• \. Severe dementia (mmse \<10)

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan, 600, Taiwan

Location

MeSH Terms

Conditions

Delirium; Fatigue; Depression; Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Dementia; Stroke; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Apnea; Respiration Disorders; Respiratory Tract Diseases; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cheung-Ter Ong, Master

  Ditmanson Medical Foundation Chiayi Christian Hospital Neurologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: March 3, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)