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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183647
Enrollment
21
Registered
2019-12-03
Start date
2018-11-15
Completion date
2019-07-01
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ataxia

Keywords

local vibration, whole body vibration, postural control

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.

Interventions

DEVICEwhole 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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mini-BESTestThe 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 ScaleThe 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 Swayschange 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).
Time-Distance Characteristics of the Gaitchange 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 Testchange from baseline at 1 min and 60 min after applications.It will be used to evaluate functional mobility.
One Leg Stance Testchange 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026