Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-07-01

Brief Summary

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This study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications on postural control in adult patients with ataxia.

The study will be included in patients aged 18-50 years, including ataxia diagnosed by the neurologist and able to walk independently. Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months and other neurological diseases other than ataxia will not be included in the study. Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations. The order of application will be decided by the coin toss randomization method. Descriptive evaluations of the patients will be done with Mini-BESTest and Trunk Impairment Scale. Stability limits and postural sways (Bertec Balance Check ScreenerTM), gait time - distance characteristics (GAITRite), functional mobility skills (Timed Up and Go Test), and static balances (One Leg Stance Test) before, 1 minute after the application and 60 minutes after the application.

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Detailed Description

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Conditions

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Ataxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The study was planned as a single blind. Evaluations will be made by the blind evaluator.

Study Groups

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Local Vibration / Whole body vibration

Local vibration will be sequentially applied to the bilateral gastrosoleus complex with the Vibrasens © device. Application, the largest part of the muscle, each limb 5'er for a total of 10 minutes, static semi-squat position will be done.

The vibration frequency is 80 Hz and the amplitude is 1 mm.

Group Type ACTIVE_COMPARATOR

whole body vibration / local vibration

Intervention Type DEVICE

Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.

Whole body vibration/local vibration

Whole body vibration application will be done with Compex® Winplate device. During this application, patients will be asked to continue static semi-squat position with 5 minutes of vibration and then 5 minutes of vibration.Vibration frequency, 30 Hz amplitude will be selected 2 mm.

Group Type ACTIVE_COMPARATOR

whole body vibration / local vibration

Intervention Type DEVICE

Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.

Interventions

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whole body vibration / local vibration

Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Located in the 18-50 age range, diagnosed with ataxia by the neurologist, patients who can walk independently

Exclusion Criteria

* Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months, and other neurological disorders other than ataxia

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No