Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03607058
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
ÖZGE ONURSAL KILINÇ, 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.

Condition or disease Intervention/treatment Phase
Ataxia Other: Kinect + Exercise Training Other: Exercise Training Not Applicable

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 1 week 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ataksik Hastalarda Oyun Temelli Egzersiz Eğitiminin Denge ve Postural Kontrol Üzerine Etkisi
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


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 1 week washout period only exercise training will be applied for 8 weeks.
Other: Kinect + Exercise Training
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 1 week 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 1 week washout period exercise training and Xbox Kinect will be applied together for 8 weeks.
Other: Exercise Training
Exercise Training: Patients will take the treatment 1-hour, 3 days in a week for 8 weeks. After 1 week 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607058


Contacts
Layout table for location contacts
Contact: Özge ONURSAL KILINÇ, Msc +903123051576 ext 183 ozgeonursal@hotmail.com
Contact: Ender AYVAT, PhD +903123051576 ext 183 ender.ayvat@gmail.com

Locations
Layout table for location information
Turkey
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Recruiting
Ankara, Turkey, 06100
Contact: ÖZGE ONURSAL KILINÇ, Msc    +903123051576 ext 183    ozgeonursal@hotmail.com   
Contact: ENDER AYVAT, PhD    +903123051576 ext 183    ender.ayvat@gmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Principal Investigator: Özge ONURSAL KILINÇ, Msc Hacettepe University
Principal Investigator: Ender AYVAT, PhD Hacettepe University
Principal Investigator: Fatma AYVAT, Msc Hacettepe University

Publications of Results:

Layout table for additonal information
Responsible Party: ÖZGE ONURSAL KILINÇ, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT03607058     History of Changes
Other Study ID Numbers: KA-17049
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms