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

Not Applicable

Completed

• Conditions: Ataxia
• Interventions: Other: Kinect + Exercise Training; Other: Exercise Training

• Registration Number: NCT03607058
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Start: 2018-08-18
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kinect + Exercise Training	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.
Exercise Training	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.

Primary Outcome Measures

Name	Time	Method
Limits of Stability Test of Neurocom Balance Master (Static Posturography)	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 Outcome Measures

Name	Time	Method
Dynamic Gait Index (DGI)	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.
International Cooperative Ataxia Rating Scale	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.
10 meter Walk Test (10mWT)	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.
Berg Balance Scale (BBS)	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.
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	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.
Trunk Impairment Scale	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.
Timed Up and Go test (TUG)	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.
Functional Reach Test (FRT)	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.
Walk Across (WA) of Neurocom Balance Master (Static Posturography)	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.
Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)	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.
Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)	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.

Trial Locations

Locations (1)

Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation; 🇹🇷 Ankara, Turkey