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

Primary Purpose

Ataxia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
whole body vibration / local vibration
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxia focused on measuring local vibration, whole body vibration, postural control

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Local Vibration / Whole body vibration

Whole body vibration/local vibration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mini-BESTest
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
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
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).
Time-Distance Characteristics of the Gait
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
It will be used to evaluate functional mobility.
One Leg Stance Test
It will be used to evaluate static balance. For the right and left lower extremities, eyes will be opened and closed in two ways.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2019
Last Updated
January 2, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04183647
Brief Title
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications
Official Title
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications on Postural Control in Adult Patients With Ataxia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia
Keywords
local vibration, whole body vibration, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations.
Masking
Outcomes Assessor
Masking Description
The study was planned as a single blind. Evaluations will be made by the blind evaluator.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local Vibration / Whole body vibration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Whole body vibration/local vibration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
whole body vibration / local vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini-BESTest
Description
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.
Time Frame
The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).
Title
Trunk Impairment Scale
Description
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..
Time Frame
The application will be made immediately after the evaluations are completed within the same day (on average 30 min before application).
Title
Limits of Stability and Postural Sways
Description
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).
Time Frame
change from baseline at 1 min and 60 min after applications.
Title
Time-Distance Characteristics of the Gait
Description
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.
Time Frame
change from baseline at 1 min and 60 min after applications.
Title
Timed Up and Go Test
Description
It will be used to evaluate functional mobility.
Time Frame
change from baseline at 1 min and 60 min after applications.
Title
One Leg Stance Test
Description
It will be used to evaluate static balance. For the right and left lower extremities, eyes will be opened and closed in two ways.
Time Frame
change from baseline at 1 min and 60 min after applications.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammed KILINÇ
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32880847
Citation
Ozvar GB, Ayvat E, Kilinc M. Immediate Effects of Local Vibration and Whole-body Vibration on Postural Control in Patients with Ataxia: an Assessor-Blind, Cross-over randomized trial. Cerebellum. 2021 Feb;20(1):83-91. doi: 10.1007/s12311-020-01187-7. Epub 2020 Sep 3.
Results Reference
derived

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

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