Pulse Wave Velocity and in Subacute Stroke Patients Following Rehabilitation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShin Kong Wu Ho-Su Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rehabilitation

    Other intervention

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Patients of ischemic stroke1 intervention

Trial outcomes

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.

Time frame
4-week

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
4-week

Other outcomes

Sponsors and contacts

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