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Clinical Trials/NCT04183647
NCT04183647
Completed
N/A

Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications on Postural Control in Adult Patients With Ataxia

Hacettepe University1 site in 1 country21 target enrollmentNovember 15, 2018
ConditionsAtaxia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ataxia
Sponsor
Hacettepe University
Enrollment
21
Locations
1
Primary Endpoint
Timed Up and Go Test
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Güngör Beyza ÖZVAR

physical therapist

Hacettepe University

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

Outcomes

Primary Outcomes

Timed Up and Go Test

Time Frame: change from baseline at 1 min and 60 min after applications.

It will be used to evaluate functional mobility.

Time-Distance Characteristics of the Gait

Time Frame: 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.

One Leg Stance Test

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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).

Study Sites (1)

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