Clinical trial NCT03784768: Effect of Plantar Vibration on Static and Dynamic Balance
Official title: Effect of Plantar Vibration on the Static and Dynamic Balance in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients
Keywords: Static balanced
Dynamic balanced
Stroke
Rehabilitation
Vibration
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
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 study (n=15) and control (n=15). Patients in study group received 45-min conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion and 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 the control group received 60-min conventional pysiotherapy session for 5-days in a week, over 4-week. Each physiotherapy session will consist of range of motion and strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Test
timeFrame: 15 minute
measure: Time Up and Go Test
timeFrame: 5 minute
measure: Berg Balance Scale
timeFrame: 15 minute
measure: Trunk Impairment Scale
timeFrame: 10 minute
measure: Functional Reach Test
timeFrame: 5 minute
measure: 10 Meter Walk Tests
timeFrame: 3 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
affiliation: Kırıkkale University
name: Birol Onal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.