- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03607058
The Effects of Game Based Exercise Training on Balance and Postural Control in Patients With Ataxia
March 14, 2022 updated by: ÖZGE ONURSAL KILINÇ, Hacettepe University
Ataksik Hastalarda Oyun Temelli Egzersiz Eğitiminin Denge ve Postural Kontrol Üzerine Etkisi
This study was planned to investigate the effects of exercise training based on Microsoft Kinect application on balance and postural control in ataxic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who meet the inclusion criteria will be divided into two groups randomly: 'Kinect and exercise training' and 'exercise training'.
The assessments will be made by a blind investigator four times, before and after the implementation of both protocols.
The evaluations will take approximately 1 hour.
The demographic information of the cases will be recorded.
Designed as cross over study, two treatment protocols will be used in this study.
The first protocol will be Xbox Kinect application plus exercise program, the second protocol will be only exercise program.
At the beginning of the study, 2 groups will be allocated (Group A and Group B) randomly.
For group A, the Xbox Kinect application plus exercise program will be applied for the first 8 weeks.
For group B, only exercise program will be applied therapy first 8 weeks.
All assessments will be repeated before and after each therapy period.
Exercise program will consist of selected balance, coordination and walking exercises according to the individual needs of patients.
After 10 weeks washout period, patients will be included in the other group.
All patients will take the treatment 1-hour, 3 days in a week for 8 weeks.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kinect + Exercise Training
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.
|
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.
|
Active Comparator: Exercise Training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Limits of Stability Test of Neurocom Balance Master (Static Posturography)
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
|
change from baseline in dynamic balance component of postural control at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Cooperative Ataxia Rating Scale
Time Frame: change from baseline in severity of ataxic symptoms at 8 weeks
|
The International Cooperative Ataxia Rating Scale was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias.
The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders.
the maximum score is 100, the minimum score is 0 in this scale.
Higher scores indicate higher levels of impairment.
Postural and gait disturbances subscale has 7 items (0-34 points), limb ataxia subscale has 7 items (0-52 points), Dysarthria subscale has 2 items (0-4 points) and oculomotor disorders subscale has 3 items (0-6 points).
The total score is obtained by summing the scores of the sub-scales.
|
change from baseline in severity of ataxic symptoms at 8 weeks
|
Timed Up and Go test (TUG)
Time Frame: change from baseline in falling risk at 8 weeks
|
TUG was developed to determine falling risk and measure the progress of balance, sit to stand, and walking.
|
change from baseline in falling risk at 8 weeks
|
Functional Reach Test (FRT)
Time Frame: change from baseline in dynamic balance at 8 weeks
|
FRT is a quick and simple, single-task dynamic test that defines functional reach as "the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position".
It is a dynamic rather than a static test and measures a person's "margin of stability" as well as ability to maintain balance during a functional task.
|
change from baseline in dynamic balance at 8 weeks
|
10 meter Walk Test (10mWT)
Time Frame: change from baseline in gait speed at 8 weeks
|
The 10mWTis a performance measure used to assess walking speed in metres per second over a short distance.
It can be employed to determine functional mobility and gait.
|
change from baseline in gait speed at 8 weeks
|
Trunk Impairment Scale
Time Frame: change from baseline in impairment of trunk at 8 weeks
|
It was developed 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.
There are 17 items in this scale and for each item, a 2-, 3- or 4-point ordinal scale is used.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
The total score for this scale ranges between 0 for a minimal performance to 23 for a perfect performance.
The total score is obtained by summing the scores of the subscales.
|
change from baseline in impairment of trunk at 8 weeks
|
Dynamic Gait Index (DGI)
Time Frame: change from baseline in balance, fall risk and gait at 8 weeks
|
The DGI was developed as a clinical tool to assess gait, balance and fall risk.
It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
The DGI was developed as a clinical tool to assess gait, balance and fall risk.
It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies.
24 is the total individual score possible.
Scores of 19 or less have been related to increase incidence of falls.
|
change from baseline in balance, fall risk and gait at 8 weeks
|
Berg Balance Scale (BBS)
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.
|
change from baseline in balance performance at 8 weeks
|
Rhythmic Weight Shift (RWS) of Neurocom Balance Master (Static Posturography)
Time Frame: change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks
|
RWS test quantifies the patient's ability to rhythmically move their Center of Gravity (COG) from left to right (lateral) and forward to backward (anterior/ posterior) between two targets at three distinct speeds: slow, medium, and fast.
|
change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks
|
Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)
Time Frame: change from baseline in postural sway velocity at 8 weeks
|
The US quantifies postural sway velocity with the patient standing on either the right or left foot with eyes open and with eyes closed.
|
change from baseline in postural sway velocity at 8 weeks
|
Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)
Time Frame: change from baseline in weight bearing at 8 weeks
|
During the WBS, the patient is instructed to maintain equal weight on each leg while standing erect and then squatting in three positions of knee flexion.
The percentage of body weight borne by each leg is measured with the patient standing at 0° (erect), 30°, 60°, and 90° of knee flexion.
|
change from baseline in weight bearing at 8 weeks
|
Walk Across (WA) of Neurocom Balance Master (Static Posturography)
Time Frame: change from baseline in gait characteristics at 8 weeks
|
The WA quantifies characteristics of gait as the patient walks across the length of the force plate.
The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate.
Measured parameters are average step width, average step length, speed and step length symmetry.
|
change from baseline in gait characteristics at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Özge ONURSAL KILINÇ, Msc, Hacettepe University
- Principal Investigator: Ender Ayvat, PhD, Hacettepe University
- Principal Investigator: Fatma Ayvat, Msc, Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2018
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
July 23, 2018
First Submitted That Met QC Criteria
July 23, 2018
First Posted (Actual)
July 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-17049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ataxia
-
Cadent TherapeuticsWithdrawnSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8 | Spinocerebellar Ataxia Type 17 | ARCA1 - Autosomal Recessive...United States
-
Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8United States, China
-
Assistance Publique - Hôpitaux de ParisCompletedSpinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia, Autosomal Recessive 3 | Episodic Ataxia, Type 7France
-
University of ChicagoPfizer; Biogen; APDM Wearable TechnologiesActive, not recruitingSpinocerebellar Ataxia Type 3 | Friedreich Ataxia | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6United States
-
Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia Genotype Type 1 | Spinocerebellar Ataxia Genotype Type 2 | Spinocerebellar Ataxia Genotype Type 3 | Spinocerebellar Ataxia Genotype Type 6 | Spinocerebellar Ataxia Genotype Type 7 | Spinocerebellar Ataxia Genotype Type 8 | Spinocerebellar Ataxia Genotype...United States
-
University of California, Los AngelesRare Diseases Clinical Research Network; Office of Rare Diseases (ORD)CompletedCerebellar Diseases | Episodic Ataxia SyndromeUnited States, Canada, United Kingdom
-
Teachers College, Columbia UniversityActive, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 7United States
-
Sclnow Biotechnology Co., Ltd.Not yet recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6
-
University of California, Los AngelesActive, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | MSA-CUnited States
-
Seoul National University HospitalCompletedAtaxia, Cerebellar | Ataxia, ProgressiveKorea, Republic of
Clinical Trials on Kinect + Exercise Training
-
Wan-Yun HuangKaohsiung Veterans General Hospital.; National Cheng Kung UniversityCompletedVirtual Reality | Physical FitnessTaiwan
-
Universidad Pablo de OlavideUnknownExercise Therapy | Severe Mental IllnessSpain
-
NYU Langone HealthNational Cancer Institute (NCI)CompletedBreast Cancer | LymphedemaUnited States
-
Universidade Federal de GoiasCompletedSleep | Anxiety | Exercise | Aging
-
Riphah International UniversityCompleted
-
Universidade da MadeiraCasa de Saúde Câmara PestanaCompletedPsychiatric DisorderPortugal
-
Centre Hospitalier Universitaire de NiceTerminatedDisease AlzheimerNetherlands, France, Australia
-
Qassim UniversityCairo UniversityCompletedBurns | Hand BurnEgypt
-
National Taiwan University HospitalRecruiting