Clinical trial NCT03607058: The Effects of Game Based Exercise Training on Balance and Postural Control in Patients With Ataxia
Official title: Ataksik Hastalarda Oyun Temelli Egzersiz Eğitiminin Denge ve Postural Kontrol Üzerine Etkisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Limits of Stability Test of Neurocom Balance Master (Static Posturography)
timeFrame: change from baseline in dynamic balance component of postural control at 8 weeks
Secondary outcomes:
measure: International Cooperative Ataxia Rating Scale
timeFrame: change from baseline in severity of ataxic symptoms at 8 weeks
measure: Timed Up and Go test (TUG)
timeFrame: change from baseline in falling risk at 8 weeks
measure: Functional Reach Test (FRT)
timeFrame: change from baseline in dynamic balance at 8 weeks
measure: 10 meter Walk Test (10mWT)
timeFrame: change from baseline in gait speed at 8 weeks
measure: Trunk Impairment Scale
timeFrame: change from baseline in impairment of trunk at 8 weeks
measure: Dynamic Gait Index (DGI)
timeFrame: change from baseline in balance, fall risk and gait at 8 weeks
measure: Berg Balance Scale (BBS)
timeFrame: change from baseline in balance performance at 8 weeks
measure: Rhythmic Weight Shift (RWS) of Neurocom Balance Master (Static Posturography)
timeFrame: change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks
measure: Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)
timeFrame: change from baseline in postural sway velocity at 8 weeks
measure: Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)
timeFrame: change from baseline in weight bearing at 8 weeks
measure: Walk Across (WA) of Neurocom Balance Master (Static Posturography)
timeFrame: change from baseline in gait characteristics at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Özge ONURSAL KILINÇ, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ender AYVAT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Fatma AYVAT, Msc
role: PRINCIPAL_INVESTIGATOR
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