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Clinical Trials/NCT03607058
NCT03607058
Completed
Not Applicable

Ataksik Hastalarda Oyun Temelli Egzersiz Eğitiminin Denge ve Postural Kontrol Üzerine Etkisi

Hacettepe University1 site in 1 country19 target enrollmentAugust 18, 2018
ConditionsAtaxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ataxia
Sponsor
Hacettepe University
Enrollment
19
Locations
1
Primary Endpoint
Limits of Stability Test of Neurocom Balance Master (Static Posturography)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2018
End Date
October 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ÖZGE ONURSAL KILINÇ

Research Assistant

Hacettepe University

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Dynamic Gait Index (DGI)(change from baseline in balance, fall risk and gait at 8 weeks)
  • International Cooperative Ataxia Rating Scale(change from baseline in severity of ataxic symptoms at 8 weeks)
  • 10 meter Walk Test (10mWT)(change from baseline in gait speed at 8 weeks)
  • Berg Balance Scale (BBS)(change from baseline in balance performance at 8 weeks)
  • Rhythmic Weight Shift (RWS) of Neurocom Balance Master (Static Posturography)(change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks)
  • Trunk Impairment Scale(change from baseline in impairment of trunk 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)
  • Walk Across (WA) of Neurocom Balance Master (Static Posturography)(change from baseline in gait characteristics at 8 weeks)
  • Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)(change from baseline in weight bearing at 8 weeks)
  • Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)(change from baseline in postural sway velocity at 8 weeks)

Study Sites (1)

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