The Effects of Game Based Exercise Training on Balance and Postural Control in Patients With Ataxia

NCT03607058 | Completed

• 1 other identifier: KA-17049
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to investigate the effects of exercise training based on Microsoft Kinect application on balance and postural control in ataxic patients.

Conditions

Ataxia

Outcome Measures

Primary Outcomes (1)

• Limits of Stability Test of Neurocom Balance Master (Static Posturography)

  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

  change from baseline in dynamic balance component of postural control at 8 weeks

Secondary Outcomes (11)

• International Cooperative Ataxia Rating Scale

  change from baseline in severity of ataxic symptoms at 8 weeks

• Timed Up and Go test (TUG)

  change from baseline in falling risk at 8 weeks

• Functional Reach Test (FRT)

  change from baseline in dynamic balance at 8 weeks

• 10 meter Walk Test (10mWT)

  change from baseline in gait speed at 8 weeks

• Trunk Impairment Scale

  change from baseline in impairment of trunk at 8 weeks

Study Arms (2)

Kinect + Exercise Training

ACTIVE COMPARATOR

Xbox Kinect and exercise training will be applied together for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. A treatment session in this arm will consist of Kinect games for 40 minutes and exercise training for 20 minutes. In this arm, patients will play each game as two repetitions. Each game lasts about 3-4 minutes, and patients will be seated for resting between the games. After 10 weeks washout period only exercise training will be applied for 8 weeks.

Other: Kinect + Exercise Training

Exercise Training

ACTIVE COMPARATOR

Exercise training will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 10 weeks washout period exercise training and Xbox Kinect will be applied together for 8 weeks.

Other: Exercise Training

Interventions

Kinect + Exercise Training OTHER

Kinect + Exercise Training : Patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will take the treatment 1-hour, 3 days in a week for 8 weeks.

Kinect + Exercise Training

Exercise Training OTHER

Exercise Training: Patients will take the treatment 1-hour, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks.

Exercise Training

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
• Ataxic patients who had a Mini Mental Test Score of 24 points and over;

You may not qualify if:

• Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
• Clinical diagnosis of cognitive impairment
• Patients who have fallen at least once in the last 6 months
• Patients who had Berg Balance Scale score of 40 points and below

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (10)

• 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

• Lange B, Chang CY, Suma E, Newman B, Rizzo AS, Bolas M. Development and evaluation of low cost game-based balance rehabilitation tool using the Microsoft Kinect sensor. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1831-4. doi: 10.1109/IEMBS.2011.6090521.

  PMID: 22254685 RESULT

• Donath L, Rossler R, Faude O. Effects of Virtual Reality Training (Exergaming) Compared to Alternative Exercise Training and Passive Control on Standing Balance and Functional Mobility in Healthy Community-Dwelling Seniors: A Meta-Analytical Review. Sports Med. 2016 Sep;46(9):1293-309. doi: 10.1007/s40279-016-0485-1.

  PMID: 26886474 RESULT

• Shih MC, Wang RY, Cheng SJ, Yang YR. Effects of a balance-based exergaming intervention using the Kinect sensor on posture stability in individuals with Parkinson's disease: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2016 Aug 27;13(1):78. doi: 10.1186/s12984-016-0185-y.

  PMID: 27568011 RESULT

• Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

  PMID: 2229941 RESULT

• Peters DM, Fritz SL, Krotish DE. Assessing the reliability and validity of a shorter walk test compared with the 10-Meter Walk Test for measurements of gait speed in healthy, older adults. J Geriatr Phys Ther. 2013 Jan-Mar;36(1):24-30. doi: 10.1519/JPT.0b013e318248e20d.

  PMID: 22415358 RESULT

• Ayvat E, Onursal Kilinc O, Ayvat F, Savcun Demirci C, Aksu Yildirim S, Kursun O, Kilinc M. The Effects of Exergame on Postural Control in Individuals with Ataxia: a Rater-Blinded, Randomized Controlled, Cross-over Study. Cerebellum. 2022 Feb;21(1):64-72. doi: 10.1007/s12311-021-01277-0. Epub 2021 May 11.

  PMID: 33973141 DERIVED

MeSH Terms

Conditions

Ataxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Özge ONURSAL KILINÇ, Msc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ender AYVAT, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Fatma AYVAT, Msc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: August 18, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)