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Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability

Primary Purpose

Stroke Patients

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vibration group
placebo group
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients focused on measuring stroke vibration fall risk postural stability, immediate effect, fall risk, postural stability

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cognitive and non-communication problems
  • Volunteer to join the work
  • Those with less than 150 kilos
  • Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox
  • Patients at least 8 weeks after stroke diagnosis

Exclusion Criteria:

  • People who are not stable due to vital signs
  • Open wounds under the soles of the feet
  • Being spastic at the level that will block the base touch
  • Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
  • 20 seconds independent standing
  • Mini Mental Test score below 24
  • Multiple sclerosis, Parkinson's disease, etc.
  • Those with vision problems
  • Patients with thoracolumbar surgery
  • Patients with spinal canal stenosis

Sites / Locations

  • Kırıkkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vibration group

placebo group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2019
Last Updated
October 31, 2019
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04034602
Brief Title
Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability
Official Title
Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
stroke vibration fall risk postural stability, immediate effect, fall risk, postural stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 stroke patients will be included in this study. The patients who meet the inclusion criteria will be divided randomly into 2 groups as vibration (n=15) and placebo (n=15).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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vibration group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
vibration group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
biodex balance system fall risk test
Description
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
Title
biodex balance system postural stability test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cognitive and non-communication problems Volunteer to join the work Those with less than 150 kilos Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox Patients at least 8 weeks after stroke diagnosis Exclusion Criteria: People who are not stable due to vital signs Open wounds under the soles of the feet Being spastic at the level that will block the base touch Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery) 20 seconds independent standing Mini Mental Test score below 24 Multiple sclerosis, Parkinson's disease, etc. Those with vision problems Patients with thoracolumbar surgery Patients with spinal canal stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birol Önal
Organizational Affiliation
Kirikkale Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale University
City
Kırıkkale
ZIP/Postal Code
71000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability

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