Clinical trial NCT04034602: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients
Keywords: stroke vibration fall risk postural stability
immediate effect
fall risk
postural stability
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: biodex balance system fall risk test
timeFrame: 5 minutes
measure: biodex balance system postural stability test
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
affiliation: Kirikkale Univercity
name: Birol Önal
role: PRINCIPAL_INVESTIGATOR
References: