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

NCT02977377 | Completed

• 1 other identifier: GO 14/397
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Ataxia

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline in sensory component of postural control at 8 weeks

Secondary Outcomes (8)

• International Cooperative Ataxia Rating Scale

  change from baseline in severity of ataxic symptoms at 8 weeks.

• Trunk Impairment Scale

  change from baseline in impairment of trunk at 8 weeks.

• Berg Balance Scale

  change from baseline in balance performance at 8 weeks.

• Barthel Index

  change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.

• Goal Assessment Scale

  change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.

Study Arms (2)

Whole body vibration/ Exercise

ACTIVE COMPARATOR

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; Other: Whole body vibration

Exercise/ Whole body vibration

ACTIVE COMPARATOR

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; Other: Whole body vibration

Interventions

Exercise therapy OTHER

Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

Exercise/ Whole body vibration; Whole body vibration/ Exercise

Whole body vibration OTHER

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.

Exercise/ Whole body vibration; Whole body vibration/ Exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Health Sciences

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 18295614 RESULT

• 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.

  PMID: 16902175 RESULT

• 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.

  PMID: 2753103 RESULT

• 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.

  PMID: 12218749 RESULT

• 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.

  PMID: 15706558 RESULT

• 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.

  PMID: 19026963 RESULT

• 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.

  PMID: 9094050 RESULT

• 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.

  PMID: 15137564 RESULT

• Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and laboratory measures of postural balance in an elderly population. Arch Phys Med Rehabil. 1992 Nov;73(11):1073-80.

  PMID: 1444775 RESULT

• Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.

  PMID: 23562111 RESULT

• 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.

  PMID: 33475935 DERIVED

MeSH Terms

Conditions

Ataxia

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ender Ayvat, Msc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Muhammed Kılınç, Assoc Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Sibel Aksu, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)