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Acute Effect of Local Vibration in Stroke Patients

No phase Interventional Acute Effect of Local Vibration Application in Stroke Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: local vibration apply.
Who it may be relevant to
Registry conditions: Acute Effect of Local Vibration Application in Stroke Patients. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Acute Effect of Local Vibration Application on Gait and Balance in Stroke Patients

Overview

The aim of the research is to examine the acute effect of local vibration application on gait and balance in stroke patients.

Detailed description

The purpose of our study; To examine the acute effect of local vibration application on spatiotemporal parameters of gait and balance in stroke patients.

Many treatment approaches are applied to accelerate motor recovery in stroke rehabilitation. These treatment approaches include Neurodevelopmental Therapy (NGT) treatment approaches and electrotherapy, traditional exercise approaches, as well as new technologies such as robotic devices and virtual reality, which offer new opportunities to increase training intensity by providing a more independent training in the field of rehabilitation. Another treatment approach that has recently attracted attention in neurorehabilitation is local or whole body vibration application. Vibration is defined as "a mechanical stimulus characterized by oscillatory movements". When vibration is viewed biomechanically, it has 3 parameters. These parameters; It is defined as the amplitude that determines the oscillation range of the vibration in millimeters, the frequency that indicates the number of repetitions in one second, and the power given by the acceleration that occurs during vibration.

Vibration can be applied to humans in two basic ways. The first method is local vibration application, which can be applied directly to the muscle or tendon with a hand-held device. The second method, called whole body vibration, is applied on the platform by a vibration source. Vibration applications in physiotherapy are generally 0.1-10 mm amplitude, 10-120 Hz. It is used in frequency and duration from 5 seconds to 60 minutes for up to 72 weeks. In whole body vibration, the degree of acceleration created by the platform surface can create a force up to 17 times the acceleration of gravity.

Wanderley et al. In their study, they applied vibration with a frequency of 100 Hz and an amplitude of 2 mm under the sole of the foot to female patients aged 60 and over with balance problems in 12 sessions of 10-minute applications for 5 weeks. As a result, they reported that vibration stimulation applied to the plantar region had positive effects on postural control and balance in women aged 60 and over with balance problems. In another study, Soffia Naghdi et al. In their case report, they reported that applying 100 Hz frequency plantar vibration to the sole of the foot of a right hemiplegic patient for 5 minutes was effective in balance development. Local vibration, in addition to the general physiotherapy and rehabilitation program, can improve walking performance in patients secondary to chronic stroke. The authors hypothesize that this could possibly be due to mechanical vibration stimulating the brain and reorganizing it. Additionally, the results of another study support this study. It has been shown that after applying low-amplitude local vibration to the flexor carpi radialis muscle and the intrinsic hand muscles of healthy individuals, there is increased excitability in the primary motor cortex area of the stimulated muscle.

When we examined the literature, we could not find any studies investigating the effect of local vibration applications to the gastrocnemius on spatiotemporal parameters and balance of walking in individuals with stroke.

Interventions

  • Device local vibration apply
    Local 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 applicat

Primary outcome measures

  • Modified Ashworth Scale [Time frame: 5 minutes]
  • Timed Up and Go Test [Time frame: 5 minutes]
  • Functional Reaching Test [Time frame: 5 Minutes]
  • Biodex Computerized Balance System [Time frame: 5 minutes]
  • Tandem Stance [Time frame: 5 minutes]
  • 10 Meter Walking Test [Time frame: 5 minutes]
  • Gait Analysis [Time frame: 10 minutes]

Eligibility criteria

Inclusion criteria

  • 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,
  • Those who score 0-3 on the Modified Rankin Scale.
  • People weighing less than 150 kilos
  • Patients who can walk independently (with an assisted device if they use an assistive device)

Exclusion criteria

  • 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
  • Patients who do not agree to participate in the study and do not give written consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 2 centers
  • Kırıkkale University — Kirikkale
  • Kırıkkale University — Kirikkale

Publications

  • Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31. PMID 33836458
  • Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863. PMID 31868686
  • 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. PMID 29740561

Identifiers

NCT: NCT06610994 · LocalVibrationStroke

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗