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

Not Applicable

Completed

• Conditions: Ataxia
• Interventions: Device: whole body vibration / local vibration

• Registration Number: NCT04183647
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-15
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-01
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whole body vibration/local vibration	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.
Local Vibration / Whole body vibration	whole body vibration / local 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.

Primary Outcome Measures

Name	Time	Method
Time-Distance Characteristics of the Gait	change from baseline at 1 min and 60 min after applications.	GAITRite (CIR System INC. Clifton, NJ 07012) walkway system will be used. GAITRite; It is an electronic walkway which consists of portable carpet and sensors embedded on the carpet and transfers every foot contact to the computer when individuals walk on the carpet. With GAITRite, base of support (cm), velocity (cm / s) and cadence (steps / min) parameters will be evaluated.
Timed Up and Go Test	change from baseline at 1 min and 60 min after applications.	It will be used to evaluate functional mobility.
One Leg Stance Test	change from baseline at 1 min and 60 min after applications.	It will be used to evaluate static balance. For the right and left lower extremities, eyes will be opened and closed in two ways.
Mini-BESTest	The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).	It will be used for performance-oriented balance assessment. The test consists of 14 items and is evaluated on a score of 0-2. In the test, "0" indicates the lowest function level and "2 en indicates the highest function level.
Trunk Impairment Scale	The application will be made immediately after the evaluations are completed within the same day (on average 30 min before application).	It will be used to evaluate trunk control. The scale has 17 items, 3 of which are static balance 10 are dynamic balance, 4 are stabilizer muscles. The total score that can be obtained is minimum "0 minimum and maximum" 23..
Limits of Stability and Postural Sways	change from baseline at 1 min and 60 min after applications.	Bertec Balance Check Screener (Model BP5050) force platform system will be used. This force platform will measure stability limits in 4 directions (anterior, posterior, right, left) and postural sways in 4 different conditions (firm surface -eyes open, firm surface-eyes closed, foam surface-eyes open, foam surface-eyes closed).

Trial Locations

Locations (1)

Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Turkey