Pulse Wave Velocity and in Subacute Stroke Patients Following Rehabilitation

NCT06224517 | Recruiting

• 1 other identifier: 20230706R
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Therefore, the aim of the study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.

Conditions

Ischemic Stroke; Arterial Stiffness; Pulse Wave Velocity; Rehabilitation

Keywords

ischemic stroke; Arterial Stiffness; pulse wave velocity; rehabilitation

Outcome Measures

Primary Outcomes (1)

• brachial-ankle pulse wave velocity

  baPWV is measured noninvasively using an oscillometric method (HBP-8000, Omron, Japan). The participants are required to abstain from caffeine for at least three hours prior to the test. The participant will be asked to rest in a supine position for a minimum of 10 minutes. Following this rest period, oscillometric cuffs were attached at the midway points of both arms and ankles for the simultaneous measurement of volume pulse and blood pressure. The arm-to-ankle distance was determined based on the patient's height. The baPWV was then computed by dividing the arm-ankle distance by the pulse time interval. The blood pressure analysis utilized the instantaneous systolic and diastolic blood pressure readings taken at the time of the baPWV measurement. For analytical purposes, an average of the values from both the left and right sides will be used.

  4-week

Secondary Outcomes (4)

• Activities of daily living

  4-week

• Balance

  4-week

• Gait function and ambulation

  4-week

• Upper limb function

  4-week

Study Arms (1)

Patients of ischemic stroke

Inclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation.

Other: Rehabilitation

Interventions

Rehabilitation OTHER

The intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities.

Patients of ischemic stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively.

You may qualify if:

• First-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging
• Sufficient cognition to understand procedures and provide informed consent.

You may not qualify if:

• Hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance
• Concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.)
• Brain tumor
• Malignancy
• Limb deficiency or amputation

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ying-Chen Kuo, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Chen Kuo, MD

CONTACT

+886-952848997; allazure1121@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 25, 2024
• Study Start: February 1, 2024
• Primary Completion: February 15, 2025
• Study Completion: June 30, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

TW (1)