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

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ClinicalTrials.gov Identifier: NCT02977377
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ender AYVAT, Hacettepe University

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

Condition or disease Intervention/treatment Phase
Ataxia Other: Exercise therapy Other: Whole body vibration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ataksili Hastalarda Tüm Vücut Vibrasyonunun Postüral Kontrol Üzerine Etkileri
Study Start Date : January 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Active Comparator: Whole body vibration/ Exercise
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.
Other: Exercise therapy
Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

Other: Whole body vibration
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.

Active Comparator: Exercise/ Whole body vibration
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.
Other: Exercise therapy
Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

Other: Whole body vibration
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 Measures :
  1. Sensory organization test of Computerized Dynamic Posturography (CDP) [ Time Frame: change from baseline in sensory component of postural control at 8 weeks ]
    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 :
  1. International Cooperative Ataxia Rating Scale [ Time Frame: change from baseline in severity of ataxic symptoms at 8 weeks. ]
    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.

  2. Trunk Impairment Scale [ Time Frame: change from baseline in impairment of trunk at 8 weeks. ]
    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.

  3. Berg Balance Scale [ Time Frame: change from baseline in balance performance at 8 weeks. ]
    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.

  4. Barthel Index [ Time Frame: change from baseline in performance of activitiesof daily living (ADL) at 8 weeks. ]
    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.

  5. Goal Assessment Scale [ Time Frame: change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks. ]
    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.

  6. Limits of stability test of Computerized Dynamic Posturography (CDP) [ Time Frame: change from baseline in dynamic balance component of postural control at 8 weeks ]
    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.

  7. Motor Control Test of Computerized Dynamic Posturography (CDP) [ Time Frame: change from baseline in automatic motor system component of postural control at 8 weeks ]
    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.

  8. Adaptation Test of Computerized Dynamic Posturography (CDP) [ Time Frame: change from baseline in postural sway in changes of support surface component of postural control at 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977377


Locations
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Turkey
Hacettepe University, Faculty of Health Sciences
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Ender Ayvat, Msc Hacettepe University
Principal Investigator: Muhammed Kılınç, Assoc Prof Hacettepe University
Study Director: Sibel Aksu, Prof Hacettepe University

Publications of Results:

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Responsible Party: Ender AYVAT, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT02977377     History of Changes
Other Study ID Numbers: GO 14/397
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms