AzTrials
AzTrials

AtaxiaNCT03607058

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

A study testing Kinect + Exercise Training and Exercise Training in people with Ataxia, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Ataxia
What is being tested?
Kinect + Exercise Training and Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Aug 2018to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Ataxia
Being tested
Kinect + Exercise Training, Exercise Training
Medical subject headings
Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinect + Exercise TrainingOther

    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.

  • Exercise TrainingOther

    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.

Study groups in NCT03607058
Study groupRoleWhat they receive
Kinect + Exercise TrainingActive comparatorXbox 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.
Receives: Other: Kinect + Exercise Training
Exercise TrainingActive comparatorExercise 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.
Receives: Other: Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (11)

  1. International Cooperative Ataxia Rating Scale

    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.

    Measured: change from baseline in severity of ataxic symptoms at 8 weeks

  2. Timed Up and Go test (TUG)

    TUG was developed to determine falling risk and measure the progress of balance, sit to stand, and walking.

    Measured: change from baseline in falling risk at 8 weeks

  3. Functional Reach Test (FRT)

    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.

    Measured: change from baseline in dynamic balance at 8 weeks

  4. 10 meter Walk Test (10mWT)

    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.

    Measured: change from baseline in gait speed at 8 weeks

  5. Trunk Impairment Scale

    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.

    Measured: change from baseline in impairment of trunk at 8 weeks

  6. Dynamic Gait Index (DGI)

    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.

    Measured: change from baseline in balance, fall risk and gait at 8 weeks

  7. Berg Balance Scale (BBS)

    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.

    Measured: change from baseline in balance performance at 8 weeks

  8. Rhythmic Weight Shift (RWS) of Neurocom Balance Master (Static Posturography)

    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.

    Measured: change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks

  9. Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)

    The US quantifies postural sway velocity with the patient standing on either the right or left foot with eyes open and with eyes closed.

    Measured: change from baseline in postural sway velocity at 8 weeks

  10. Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)

    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.

    Measured: change from baseline in weight bearing at 8 weeks

  11. Walk Across (WA) of Neurocom Balance Master (Static Posturography)

    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.

    Measured: change from baseline in gait characteristics at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start18 Aug 2018
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607058
Sponsor's protocol ID
KA-17049
Status last verified
Mar 2022
First submitted
23 Jul 2018
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19026963

  • 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.

    PubMed 9094050

  • 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.

    PubMed 15137564

  • 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.

    PubMed 1444775

  • 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.

    PubMed 22254685

  • 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.

    PubMed 26886474

  • 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.

    PubMed 27568011

  • 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.

    PubMed 2229941

  • 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.

    PubMed 22415358

  • 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.

    PubMed 33973141

Questions about this trial

What is this clinical trial studying?

A study testing Kinect + Exercise Training and Exercise Training in people with Ataxia, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03607058, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in