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Completed

NCT Number: NCT04271891

the Effect of WBPC on Subacute Stroke Patients

Whole body periodic acceleration (WBPA) is a head-to-toe movement. The function WBPA works as adding pulses to the circulation. This motion increases shear stress to the endothelium, which stimulates increased release of endothelial-derived nitric oxide (eNO), prostaglandin E-2, tissue plasminogen activator (TPA) into the circulation, and these substances are cardioprotective and contribute to vasodilatation. The WBPA were not well studied than whole body vibration (WBV), a vertical rocking training machine, and most researches focused on cardioprotective effects. A study revealed the effect of Moderate-Intensity Exercise and Whole-Body Periodic Acceleration on Nitric Oxide release was the same. This instrument is quite safe and was applied to patients with varied diseases in previous study. No sound contraindication was mentioned till now.

Our hypothesis is assuming that the circulation of brain could improve after the intervention of WBPA, and stroke recovery and cadio-pulmonary function will improve subsequently.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Changhua, 500, Taiwan

About this study

So the investigators will recruit subacute stroke patients as our subjects. The patient who is booked to our rehabilitation ward for further rehabilitation programs is eligible for our study. the investigators will recruit 30 patients, and randomize them to experimental and control group. This study is going to be single blinded, which the evaluator is blinded to the condition of the subjects. Whether experimental or control groups will received the same intensive rehabilitation programs (6 days a week). The experimental group will receive additional WBPA treatment. The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks. The evaluator will assess twice, before and after the experiment period. The measurements include: muscle power, brunnstrom stages, Barthel Index, functional independence measure (FIM), time up and go test, 6 minutes walk test, Fugl-Meyer Assessment, berg balance scale, cardio-pulmonary test. In addition, to confirm the immediate effect of WBPA over brain circulation, the investigators will choose 6 patients to received carotid ultrasonography before and immediately after the WBPA treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subacute stroke patient onset 1-3 months, age from 40-80 years-old

Exclusion criteria

  • Cognition impaired(MMSE<24), not first-ever stroke, MI history, AF, CHF, NIHSS>12

Treatment and study plan

WBPC

Device

The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks.

Without WBPC

Device

Not treat with WBPC

Primary outcomes

  1. Functional independent measurement(FIM)

    Time frame: up to 3 weeks

    Score from 18 to 126, assessment of degree of disability depends , 18 categories(score from 1~7 points, 1 = <25% independence; total assistance required, 7 = 100% independence), focusing on motor and cognitive function, Represent post-stroke patient's ADL function

  2. Brunnstrom stage,

    Time frame: up to 3 weeks

    Stage I to V, stage I: flaccid ; stage II: spasticity appeared, associated movement; stage III: increased spasticity, synnergy movement; stage IV: decreased spasticity, breaking synergy; stgae V:most independent movement; stage VI: normal. Represent post stroke limb function

  3. modified Ashworth Scale,

    Time frame: up to 3 weeks

    From 0 to 4 , evaluate post stroke patient's spasticity, 0: No increase in muscle tone; 1: Slight increase in muscle tone;1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3: Considerable increase in muscle tone, passive movement difficult;4: Affected part(s) rigid in flexion or extension

Secondary outcomes

  1. quality of life: short form- 36

    Time frame: up to 3 weeks

    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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