the Effect of WBPC on Subacute Stroke Patients
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|ClinicalTrials.gov Identifier: NCT04271891|
Recruitment Status : Completed
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: WBPC Device: Without WBPC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: With WBPC
Intensive rehabilitation programs :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 additional WBPC: The duration will be 30 minutes a time
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.
Placebo Comparator: Control
Intensive rehabilitation programs: 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: Without WBPC
Not treat with WBPC
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271891
|Changhua Christian Hospital|
|Changhua, Taiwan, 500|