Clinical trial NCT02977377: The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia
Official title: Ataksili Hastalarda Tüm Vücut Vibrasyonunun Postüral Kontrol Üzerine Etkileri
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia

Detailed description: Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out period, patients assigned other therapy period. All assessments will be repeated before and after each therapy period. Exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

The evaluation parameters consists of demographic information, Computerized Dynamic Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg Balance Scale, Barthel Index and Goal Assessment Scale.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ataxia
* Ataxic patients who are able to walk 25 m independently

Exclusion Criteria:

* Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
* Clinical diagnosis of cognitive impairment

Primary outcomes:
measure: Sensory organization test of Computerized Dynamic Posturography (CDP)
timeFrame: change from baseline in sensory component of postural control at 8 weeks
Secondary outcomes:
measure: International Cooperative Ataxia Rating Scale
timeFrame: change from baseline in severity of ataxic symptoms at 8 weeks.
measure: Trunk Impairment Scale
timeFrame: change from baseline in impairment of trunk at 8 weeks.
measure: Berg Balance Scale
timeFrame: change from baseline in balance performance at 8 weeks.
measure: Barthel Index
timeFrame: change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.
measure: Goal Assessment Scale
timeFrame: change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.
measure: Limits of stability test of Computerized Dynamic Posturography (CDP)
timeFrame: change from baseline in dynamic balance component of postural control at 8 weeks
measure: Motor Control Test of Computerized Dynamic Posturography (CDP)
timeFrame: change from baseline in automatic motor system component of postural control at 8 weeks
measure: Adaptation Test of Computerized Dynamic Posturography (CDP)
timeFrame: change from baseline in postural sway in changes of support surface component of postural control at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences
Study officials:
affiliation: Hacettepe University
name: Ender Ayvat, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Muhammed Kılınç, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Sibel Aksu, Prof
role: STUDY_DIRECTOR
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citation: Ayvat E, Kilinc M, Ayvat F, Onursal Kilinc O, Aksu Yildirim S. The Effect of Whole Body Vibration on Postural Control of Ataxic Patients: a Randomized Controlled Cross-Over Study. Cerebellum. 2021 Aug;20(4):533-541. doi: 10.1007/s12311-021-01233-y. Epub 2021 Jan 21.