Acute Effect of Local Vibration in Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorKırıkkale University
About this trial
The aim of the research is to examine the acute effect of local vibration application on gait and balance in stroke patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
45-75 years old diagnosed with stroke
Being diagnosed with ischemic or hemorrhagic stroke,
Not having cooperation and communication problems,
Stroke individuals with gastrosoleus spasticity, those with a MAS score of 2 or below,
Disqualifiers
Have undergone surgery or botox for spasticity in the last 6 months,
Those with joint contracture,
Having a neurological disease other than stroke that may affect the patient's ability to walk and stand independently, or having pain in the lower extremity joints and a history of fractures in the lower extremities in the last 6 months,
Having spasticity that prevents sole contact
Trial design
Design model
Crossover
Treatments tested in this trial
local vibration apply
DeviceLocal vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. Vibrasens© is a mechanical vibrator that produces transcutaneous vibration stimulations used in sensory-motor rehabilitation. Vibrasens©; It is a non-invasive, therapeutic device. Vibrasens© includes 1 pilot unit, 1 manual vibrator VB200, 4 flat skin contactors for tendon application, 4 round skin contactors for skin application, 1 power supply, 1 user manual and 1 protocol guide. LV application will be applied to the most swollen part of the spastic medial gastrocnemius muscles in the treatment group for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: local vibration apply groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Modified Ashworth Scale
This scale is a reliable and valid scale that is widely used in the evaluation of muscle tone. Resistance to passive movement is rated from 0 to 4.
Time frame
5 minutes2
Timed Up and Go Test
It will be applied for mobility and fall risk. This test will be performed by measuring the time taken by the individual to get up from the chair without arm support after giving the "go" command while sitting in a chair, walking 3 meters in a pre-determined area, turning around and sitting on the chair again without using his or her arms.
Time frame
5 minutes3
Functional Reaching Test
The patient raises his dominant arm 90 degrees, makes a fist, and reaches forward as far as he can to follow the measuring rod placed at shoulder level. Reaching distance is recorded. It is a reliable test with normal values. 15cm and 15cm. Below 15 to 25 cm the risk of falling increases significantly. indicates a moderate fall risk
Time frame
5 Minutes4
Biodex Computerized Balance System
Individuals' postural control will be evaluated with the Biodex Computerized Balance System. The Biodex Computerized Balance System is a multi-axis device that objectively measures and records an individual's ability to stabilize the relevant joint under dynamic stress. Postural stability test and Fall Risk Test will be performed using two different tests. Postural stability testing evaluates static balance in a standing position. The amount of deviation from the medial-lateral and anterior-posterior axes is calculated as a result of the test. According to these deviation values, general instability index, anterior-posterior stability index and medial-lateral stability index scores are obtained. A fall risk test is a test that objectively evaluates the risk of falling. The reactions of the body according to the changing ground structure are detected and recorded and a value is obtained as a result of the test.
Time frame
5 minutesSponsors and contacts
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Source ClinicalTrials.gov