An interventional study of vibration group and placebo group in Stroke Patients, sponsored by Kırıkkale University. Completed at 1 site in Turkey. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Kırıkkale University · Not applicable, Interventional, and Treatment
The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients.
Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the vibration group and the placebo group.Patients will be taken to the placebo and vibration group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Kırıkkale University is the lead sponsor of 112 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.
Other: vibration group
the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
Other: placebo group
plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.
the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
biodex balance system fall risk test
Fall Risk Test is a test used to determine the risk of falling. The higher the score, the higher the risk of falling. The device compares the test results with normal age-related data to calculate the risk of falling, the platform was set to move from 12 to 8, with the platform moving. The test is carry out with 3 repetitions, each with a resting time of 10 seconds each, lasting 20 's each while the platform is static. On the support surface formed by placing the two legs in a comfortable position on the platform, it is requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. The average of these 3 repetitions is automatically calculated by the device for the risk of falling.
Time frame: 5 minutes
biodex balance system postural stability test
The Postural Stability Test assessment the participant's ability to control the center of gravity. The extent to which the participant's position deviates from the center is measured and reports the mean deviation as the stability index. A low score indicates that the amount of deviation is small and postural stability is good. If the standard deviation is high, the participant's postural oscillation is also high when the test platform is in a static state, each is 20 seconds lasting, between 10 seconds rest period was done as 3 repetitions. On the support surface formed by placing the two legs in a comfortable position on the platform, it was requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. For the Mediolateral Stability Index, Anterioposterior Stability Index and General Stability Index showing the postural stability, the mean of 3 replicates of this test was automatically calculated by the device.
Time frame: 5 minutes
Plan to share: No
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Kırıkkale University