- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03784768
Effect of Plantar Vibration on Static and Dynamic Balance
June 30, 2021 updated by: Birol Önal, Kırıkkale University
Effect of Plantar Vibration on the Static and Dynamic Balance in Stroke Patients
The aim of this study is to have a positive effect on the static and dynamic balance of vibration applied to the foot base in stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 education group and the control group.
Patients will be taken to the control and study 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.
Patients in the control group will be given routine conventional physiotherapy in 4-week and 60-minute sessions.
The training group will be given routine conventional physiotherapy in 4-week and 45-minute sessions.In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
Individuals before; age, gender, marital status, nutritional characteristics, habits, smoking and alcohol, auxiliary devices, background information, family history, educational status, social security, previous or current occupation, frequency of fall, cause of fall and drugs used will be questioned.
Static and dynamic equilibrium parameters will be evaluated at the beginning of the study and at the end of the 4th week.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kırıkkale, Turkey, 71000
- Kırıkkale University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 45-70 years of age stroke areas
- Cognitive and non-communication problems
- Volunteer to join the work
- Those with less than 150 kilos
- Can walk 10 meters independently (with assistive device if available)
- Patients with a maximum level of 2-3 spasticity according to the Modified Ashworth Scale
- Patients at least 8 weeks after stroke diagnosis
Exclusion Criteria:
- People who are not stable due to vital signs
- Those with coronary heart disease
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plantar Vibration Group
Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
|
Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
|
Active Comparator: Control Group
Patients in the control group will be received 60-minute conventional pysiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy session will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
|
Patients in control group will be received 60-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Mental State Test
Time Frame: 15 minute
|
It was used to determine the cognitive state before the training.
The Mini-Mental State Test was first published by Folstein et al.
It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.
The ideal threshold value of the Mini-Mental State Test was found to be 24.
|
15 minute
|
Time Up and Go Test
Time Frame: 5 minute
|
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
|
5 minute
|
Berg Balance Scale
Time Frame: 15 minute
|
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully.
The total score of the test is between 0-56.0-20
points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
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15 minute
|
Trunk Impairment Scale
Time Frame: 10 minute
|
Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3
items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.
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10 minute
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Functional Reach Test
Time Frame: 5 minute
|
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1).
The placement of the end of the third metacarpal along the yardstick will recorded.
Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded.
No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.
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5 minute
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10 Meter Walk Tests
Time Frame: 3 minute
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Walking speed are measure by timing subjects over 10 meters with a stopwatch.
To avoid the effects of acceleration and deceleration, measurements take over the middle 10 meters of a 14-meter walkway.
It is repeated 2 times.
|
3 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Birol Onal, Kırıkkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
- Wanderley FS, Alburquerque-Sendin F, Parizotto NA, Rebelatto JR. Effect of plantar vibration stimuli on the balance of older women: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):199-206. doi: 10.1016/j.apmr.2010.10.014.
- Onal B, Sertel M, Karaca G. Effect of plantar vibration on static and dynamic balance in stroke patients: a randomised controlled study. Physiotherapy. 2022 Sep;116:1-8. doi: 10.1016/j.physio.2022.02.002. Epub 2022 Feb 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2018
Primary Completion (Actual)
June 20, 2019
Study Completion (Actual)
July 25, 2019
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
December 20, 2018
First Posted (Actual)
December 24, 2018
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
June 30, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- strokeandvibration
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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