Acute Effect of Local Vibration in Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Plantar Vibration in Stroke

NCT06848153

Stroke

COMPLETED NA

Gait and Falling Risk in Patient With Stroke

NCT07038421

Stroke

COMPLETED

Effects of Backward Gait Training in Chronic Stroke Patients

NCT04903392

Chronic Stroke Patients

UNKNOWN NA

The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke

NCT06059482

Stroke

COMPLETED

Effects of Respiratory Physiotherapy on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength

NCT04473872

Stroke Patients

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Effect of Local Vibration Application in Stroke Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

local vibration apply group

Local vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. It will be applied to the most swollen part of the spastic medial gastrocnemius muscles for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm.

Group Type EXPERIMENTAL

local vibration apply

Intervention Type DEVICE

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 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.

placebo group

The device will be contacted to the same areas of the patients in the vibration group for only 10 minutes.

Group Type PLACEBO_COMPARATOR

local vibration apply

Intervention Type DEVICE

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 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes