Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability

Kırıkkale University

Status: Completed

Conditions: Stroke Patients

Treatments: Other: vibration group; Other: placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT04034602

vibrationimmediateeffect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

vibration group

Experimental group

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.

Treatment:

Other: vibration group

placebo group

Active Comparator group

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.

Treatment:

Other: placebo group