Clinical trial NCT04183647: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Keywords: local vibration, whole body vibration, postural control
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mini-BESTest
timeFrame: The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).
measure: Trunk Impairment Scale
timeFrame: The application will be made immediately after the evaluations are completed within the same day (on average 30 min before application).
measure: Limits of Stability and Postural Sways
timeFrame: change from baseline at 1 min and 60 min after applications.
measure: Time-Distance Characteristics of the Gait
timeFrame: change from baseline at 1 min and 60 min after applications.
measure: Timed Up and Go Test
timeFrame: change from baseline at 1 min and 60 min after applications.
measure: One Leg Stance Test
timeFrame: change from baseline at 1 min and 60 min after applications.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Muhammed KILINÇ
role: STUDY_DIRECTOR
References:
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.