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The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia

Primary Purpose

Ataxia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise therapy
Whole body vibration
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Whole body vibration/ Exercise

Exercise/ Whole body vibration

Arm Description

Exercise therapy and whole body vibration will be applied together for 8 weeks. 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) before exercises. After 1 week washout period, exercise program will apply for 8 weeks.

Exercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks.

Outcomes

Primary Outcome Measures

Sensory organization test of Computerized Dynamic Posturography (CDP)
Computerized Dynamic Posturography (CDP) is a unique assessment technique used to objectively quantify and differentiate among the wide variety of possible sensory, motor, and central adaptive impairments to balance control. CDP has severeal test protocols; a Sensory Organization Test (SOT), Limits of Stability Test (LOS), a Motor Control Test (MCT) and an Adaptation Test (ADT) used in the study. Sensory organization test (SOT) evaluates the relative contributions of vestibular, visual and somatosensory systems to balance maintenance when somatosensory information regarding the orientation of the body's centre of gravity is systematically manipulated.

Secondary Outcome Measures

International Cooperative Ataxia Rating Scale
The ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria and Oculomotor disorders.
Trunk Impairment Scale
To measure the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as co-ordination of trunk movement. Three subscales: static sitting, balance, dynamic sitting balance and coordination. Each subscale has between three and 10 items.
Berg Balance Scale
A 14-item objective measure designed to assess static balance and fall risk. Static and dynamic activities of varying difficulty are performed.Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed.Maximum score is 56.
Barthel Index
The Barthel includes 10 personal activities. Clinically, the Barthel can be administered via interview, by observation of the patient's performance in a specific setting, or by asking the patient to demonstrate an activity.The response categories of disability in an activity were defined and rated in scale steps (0, 5), (0, 5, 10), (0, 5, 10, 15) dependent on the item. For example, for performance of dressing activity, 0 means dependent, 5 means patient needs help but can do about half unaided, 10 means independent (including buttons, zips, laces, etc.) An overall score is formed by adding scores on each rating. Scores range from 0 (totally dependent) to 100 (fully independent), in steps of 5, with higher scores indicating greater independence.
Goal Assessment Scale
The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measure, but these measures are scored in a standardized way. "Successful" outcomes are agreed upon prior to intervention. Scoring: Each goal is rated on a 5-point scale. 0 = Patient achieves the expected level; +1 = somewhat more than expected; +2 = much more than expected; -1 = somewhat less than expected; -2 = much less than expected. Overall score is calculated by incorporating the goal outcome scores into a single aggregated T-score. (Optional): Goals may be weighted by the patient for importance or difficulty.
Limits of stability test of Computerized Dynamic Posturography (CDP)
Limits of stability test (LOS) assesses dynamic balance during the performance of specific tasks with visual feedback. It quantifies objectively the maximum distance a person can lean in a given direction without losing balance, stepping or reaching for assistance.
Motor Control Test of Computerized Dynamic Posturography (CDP)
Motor Control Test (MCT) assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of platform translations of varied sizes in forward and backward directions elicit automatic postural responses. The size of the translation is scaled to the patient's height to produce sway disturbances of equal size.
Adaptation Test of Computerized Dynamic Posturography (CDP)
Adaptation Test (ADT) assesses the patient's ability to minimize sway when exposed to irregularities and unexpected changes in support surface properties. Sequences of platform rotations in the toes-up or toes-down direction elicit automatic motor responses.

Full Information

First Posted
November 18, 2016
Last Updated
December 3, 2017
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02977377
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration/ Exercise
Arm Type
Active Comparator
Arm Description
Exercise therapy and whole body vibration will be applied together for 8 weeks. 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) before exercises. After 1 week washout period, exercise program will apply for 8 weeks.
Arm Title
Exercise/ Whole body vibration
Arm Type
Active Comparator
Arm Description
Exercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Whole body vibration
Intervention Description
4 sets, 1 min application and 1min rest whole body vibration and after that exercises. Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
Primary Outcome Measure Information:
Title
Sensory organization test of Computerized Dynamic Posturography (CDP)
Description
Computerized Dynamic Posturography (CDP) is a unique assessment technique used to objectively quantify and differentiate among the wide variety of possible sensory, motor, and central adaptive impairments to balance control. CDP has severeal test protocols; a Sensory Organization Test (SOT), Limits of Stability Test (LOS), a Motor Control Test (MCT) and an Adaptation Test (ADT) used in the study. Sensory organization test (SOT) evaluates the relative contributions of vestibular, visual and somatosensory systems to balance maintenance when somatosensory information regarding the orientation of the body's centre of gravity is systematically manipulated.
Time Frame
change from baseline in sensory component of postural control at 8 weeks
Secondary Outcome Measure Information:
Title
International Cooperative Ataxia Rating Scale
Description
The ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria and Oculomotor disorders.
Time Frame
change from baseline in severity of ataxic symptoms at 8 weeks.
Title
Trunk Impairment Scale
Description
To measure the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as co-ordination of trunk movement. Three subscales: static sitting, balance, dynamic sitting balance and coordination. Each subscale has between three and 10 items.
Time Frame
change from baseline in impairment of trunk at 8 weeks.
Title
Berg Balance Scale
Description
A 14-item objective measure designed to assess static balance and fall risk. Static and dynamic activities of varying difficulty are performed.Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed.Maximum score is 56.
Time Frame
change from baseline in balance performance at 8 weeks.
Title
Barthel Index
Description
The Barthel includes 10 personal activities. Clinically, the Barthel can be administered via interview, by observation of the patient's performance in a specific setting, or by asking the patient to demonstrate an activity.The response categories of disability in an activity were defined and rated in scale steps (0, 5), (0, 5, 10), (0, 5, 10, 15) dependent on the item. For example, for performance of dressing activity, 0 means dependent, 5 means patient needs help but can do about half unaided, 10 means independent (including buttons, zips, laces, etc.) An overall score is formed by adding scores on each rating. Scores range from 0 (totally dependent) to 100 (fully independent), in steps of 5, with higher scores indicating greater independence.
Time Frame
change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.
Title
Goal Assessment Scale
Description
The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measure, but these measures are scored in a standardized way. "Successful" outcomes are agreed upon prior to intervention. Scoring: Each goal is rated on a 5-point scale. 0 = Patient achieves the expected level; +1 = somewhat more than expected; +2 = much more than expected; -1 = somewhat less than expected; -2 = much less than expected. Overall score is calculated by incorporating the goal outcome scores into a single aggregated T-score. (Optional): Goals may be weighted by the patient for importance or difficulty.
Time Frame
change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.
Title
Limits of stability test of Computerized Dynamic Posturography (CDP)
Description
Limits of stability test (LOS) assesses dynamic balance during the performance of specific tasks with visual feedback. It quantifies objectively the maximum distance a person can lean in a given direction without losing balance, stepping or reaching for assistance.
Time Frame
change from baseline in dynamic balance component of postural control at 8 weeks
Title
Motor Control Test of Computerized Dynamic Posturography (CDP)
Description
Motor Control Test (MCT) assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of platform translations of varied sizes in forward and backward directions elicit automatic postural responses. The size of the translation is scaled to the patient's height to produce sway disturbances of equal size.
Time Frame
change from baseline in automatic motor system component of postural control at 8 weeks
Title
Adaptation Test of Computerized Dynamic Posturography (CDP)
Description
Adaptation Test (ADT) assesses the patient's ability to minimize sway when exposed to irregularities and unexpected changes in support surface properties. Sequences of platform rotations in the toes-up or toes-down direction elicit automatic motor responses.
Time Frame
change from baseline in postural sway in changes of support surface component of postural control at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ender Ayvat, Msc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammed Kılınç, Assoc Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sibel Aksu, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18295614
Citation
Ebersbach G, Edler D, Kaufhold O, Wissel J. Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. Arch Phys Med Rehabil. 2008 Mar;89(3):399-403. doi: 10.1016/j.apmr.2007.09.031.
Results Reference
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PubMed Identifier
16902175
Citation
van Nes IJ, Latour H, Schils F, Meijer R, van Kuijk A, Geurts AC. Long-term effects of 6-week whole-body vibration on balance recovery and activities of daily living in the postacute phase of stroke: a randomized, controlled trial. Stroke. 2006 Sep;37(9):2331-5. doi: 10.1161/01.STR.0000236494.62957.f3. Epub 2006 Aug 10.
Results Reference
result
PubMed Identifier
2753103
Citation
Roll JP, Vedel JP, Ribot E. Alteration of proprioceptive messages induced by tendon vibration in man: a microneurographic study. Exp Brain Res. 1989;76(1):213-22. doi: 10.1007/BF00253639.
Results Reference
result
PubMed Identifier
12218749
Citation
Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Jarvinen TL, Jarvinen M, Oja P, Vuori I. Effect of four-month vertical whole body vibration on performance and balance. Med Sci Sports Exerc. 2002 Sep;34(9):1523-8. doi: 10.1097/00005768-200209000-00020.
Results Reference
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PubMed Identifier
15706558
Citation
Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
Results Reference
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PubMed Identifier
19026963
Citation
Yelnik A, Bonan I. Clinical tools for assessing balance disorders. Neurophysiol Clin. 2008 Dec;38(6):439-45. doi: 10.1016/j.neucli.2008.09.008. Epub 2008 Oct 18.
Results Reference
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PubMed Identifier
9094050
Citation
Trouillas P, Takayanagi T, Hallett M, Currier RD, Subramony SH, Wessel K, Bryer A, Diener HC, Massaquoi S, Gomez CM, Coutinho P, Ben Hamida M, Campanella G, Filla A, Schut L, Timann D, Honnorat J, Nighoghossian N, Manyam B. International Cooperative Ataxia Rating Scale for pharmacological assessment of the cerebellar syndrome. The Ataxia Neuropharmacology Committee of the World Federation of Neurology. J Neurol Sci. 1997 Feb 12;145(2):205-11. doi: 10.1016/s0022-510x(96)00231-6.
Results Reference
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PubMed Identifier
15137564
Citation
Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
Results Reference
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Citation
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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.
Results Reference
derived

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The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia

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