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Ischemic StrokeNCT06224517

Pulse Wave Velocity and in Subacute Stroke Patients Following Rehabilitation

An observational study of Ischemic Stroke and Arterial Stiffness, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Rehabilitation
How many people
25 participants
Where
1 siteTaiwan
Study dates
1 Feb 2024to 30 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying-Chen Kuo, MD contact

+886-952848997

allazure1121@gmail.com

Taiwan1 site, 1 recruiting
  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111

    Ying Chen Kuo, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: The Improvement in Pulse Wave Velocity and Its Correlation With Clinical Outcomes in Subacute Stroke Patients Following Rehabilitation

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.

Read the detailed description

Objectives: The purpose of this study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.

Background: Arterial stiffness, increasing with age, is a significant risk factor for atherosclerotic diseases and a predictor of mortality from various causes, including symptomatic strokes. The brachial-ankle pulse wave velocity (baPWV), a reliable measure of arterial stiffness, correlates with cardiovascular events and mortality risk. Clinical improvements post-ischemic stroke align with a decrease in PWV, emphasizing arterial stiffness's role in recovery. Previous studies indicate significant differences in pressure waveforms and baPWV between stroke patients and control groups. Despite evidence of baPWV's prognostic value in predicting functional outcomes after acute cerebral infarction, the literature on its relation to functional recovery, especially upper limb function, in subacute stroke patients remains limited.

Study Design: 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. Demographic and baseline clinical data, including age, gender, stroke duration (day), lesion side, stroke type, underlying disease, severity of neurological deficit (NIHSS) at admission were recorded. Once their neurological symptoms have stabilized, all patients will have their baPWV and functional outcome measurements before and four weeks after undergoing intensive rehabilitation therapy.

Methods: 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.

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. The primary outcome is baPWV, measured noninvasively using an oscillometric method. Patients maintain their prescribed medication regime throughout. Secondary outcomes assessed include activities of daily living, balance, gait function, ambulation, and upper limb function.

Effect: Arterial stiffness in subacute stroke patients can be improved after four weeks of intensive rehabilitation therapy. After four weeks of intensive rehabilitation training, the brachial-ankle pulse wave velocity (baPWV) will decrease and will be negatively correlated with functional recovery.

Being tested
Rehabilitation
Keywords
ischemic stroke, Arterial Stiffness, pulse wave velocity, rehabilitation
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    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.

Study groups in NCT06224517
Study groupRoleWhat they receive
Patients of ischemic strokeInclusion 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.
Receives: Other: Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-week

Secondary outcomes (4)
  1. Activities of daily living

    Chinese version of the Modified Barthel Index (MBI-C) is used to assess performance in basic ADL. The validity and reliability of MBI-C were good stroke patients according to previous research. the maximum score of 100 represents a patient fully independent in performing basic ADL, whereas the lowest score (0) represents a totally dependent state.

    Measured: 4-week

  2. Balance

    he Berg balance scale (BBS) is used to assess balance function, providing a measure of a participant's stability while executing routine functional tasks encountered in daily life. The BBS uses a 5-point grading system, with each task scored from 0 to 4. A maximum achievable score of 56 represents an indication of excellent balance. The interrater reliability, intrarater reliability, and test-retest reliability were excellent in stroke patients.

    Measured: 4-week

  3. Gait function and ambulation

    Gait function and ambulation ability are evaluated by Functional ambulation category (FAC). FAC test identifies six degrees of walking capability, determined by the extent of physical assistance needed. The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). It is straightforward to administer, simple to interpret, and cost-effective. The FAC has excellent reliability and good validity in stroke patients.

    Measured: 4-week

  4. Upper limb function

    The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is widely used in stroke patients to evaluate the severity of stroke and quantify the recovery process, and demonstrates good reliability, validity, and responsiveness. The assessment has 33 items, which are further divided into four subcategories: shoulder/elbow (comprising 18 items), wrist (5 items), hand (7 items), and coordination/speed (3 items). The scoring for each item is on a 3-point ordinal scale and a maximum total score of 66 indicates better sensorimotor function.

    Measured: 4-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start1 Feb 2024
  3. Primary completion15 Feb 2025
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06224517
Sponsor's protocol ID
20230706R
Status last verified
Feb 2025
First submitted
5 Jan 2024
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Arterial Stiffness, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying-Chen Kuo, MD (+886-952848997, allazure1121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brachial-ankle pulse wave velocity (time frame: 4-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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