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The Effect of Different Virtual Reality Trainings on Gait, Balance and Posture of Individuals With Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exergame
exergame
exercise
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring dementia, virtual reality, exergame, gait

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with dementia
  • Mini-Mental State Examination (MMSE) score between 18-23 points
  • Able to walk independently with/without a walking aid (a single point cane)
  • Able to speak and understand Turkish
  • Understand simple commands
  • At least primary education

Exclusion Criteria:

  • Severly vision and hearing problems
  • Undergo acute retinal hemorrhage or ophthalmic surgery
  • Acute or chronic neurological problems
  • Musculoskeletal and/or neurological problems affecting movement and balance
  • Vestibular problem and/or use medicine
  • Uncontrolled cardiovascular disease, congestive heart failure, acute myocarditis, pulmonary hypertension, or using a pacemaker
  • Malignancy
  • Orthopedic or neurological surgery in the past 6 months

Sites / Locations

  • Ankara Yıldırım Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

VR 1 Group

VR 2 Group

Control Group

Arm Description

In this group, participants received standard exercise and exergame training with Microsoft Xbox 360 Kinect for 2 days per week for 6 weeks.

In this group, participants received standard exercise and exergame training with ALDA balance gear for 2 days per week for 6 weeks.

In this group, participants received only standard exercise for 2 days per week for 6 weeks.

Outcomes

Primary Outcome Measures

gait speed
Gait speed was assessed by BTS G-Walk inertial sensor. The sensor, connected to the Lumbal 4-5 intervertebral space via a semi-elastic belt, transfers the spatiotemporal characteristics of the gait to the computer via Bluetooth® 3.0 (G-Studio® software). In our study, participants were asked to walk in a corridor of 8 meters.

Secondary Outcome Measures

Spatiotemporal Characteristics of Gait
Spatiotemporal characteristics of gait was assessed by BTS G-Walk inertial sensor. The assessed characteristics were cadence, stride length, left and right step length, step length/height ratio, gait cycle time,stance phase %, swing phase%, double support %, single support %. The sensor, connected to the Lumbal 4-5 intervertebral space via a semi-elastic belt, transfers the spatiotemporal characteristics of the gait to the computer via Bluetooth® 3.0 (G-Studio® software). In our study, participants were asked to walk in a corridor of 8 meters.
Berg Balance Scale
Berg Balance Scale (BBS) was used to evaluate static balance ability.It is a widely used and validated scale for elderly people. Validity and reliability of BBS in Turkish was established by Sahin et al. The scale includes 14 functional activities such as transfers, turning, taking objects from the ground. Each activity scores between 0-4 and high scores indicate good balance ability.
Timed Up and Go Test
Timed Up and Go Test (TUGT) was used to assessed dynamic balance ability. Participants were asked to stand up from the chair, walk 3 meters and go back and sit on the chair. Performance time recorded in seconds.
New York Posture Scale
New York Posture Scale was used to evaluate upright posture. It evaluates head, shoulders, spine, hip and foot alignment in the frontal plane. It evaluates head, thorax, shoulders, upper thoracic region, trunk, abdomen and lower lumbar region alignment in the sagittal plane. In total, 13 regions are evaluated. Each item on the scale gets 1, 3 or 5 points depending on the degree of deviation from the normal. High scores represent a good posture.

Full Information

First Posted
May 2, 2020
Last Updated
May 6, 2020
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04377191
Brief Title
The Effect of Different Virtual Reality Trainings on Gait, Balance and Posture of Individuals With Dementia
Official Title
Comparison of The Effect of Two Different Virtual Reality Trainings on Gait, Balance and Posture of Individuals With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
November 9, 2019 (Actual)
Study Completion Date
December 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Dementia, a part of geriatric syndrome, is characterized by the deterioration of multiple cognitive domains such as memory, language, orientation, learning and personality as a result of damage to the central nervous system and in terms prognosis persistent and often progressive clinical condition. In the epidemiological studies it is stated that the number of the dementia affected people approximately 2 times in every 20 years. In several studies, it has been mentioned that cognitive disorders affect individuals' motor function such as gait and postural responses. These effects lead to a vicious circle by causing immobilization of individuals due to a decrease in cognitive functions in addition to immobilization due to aging. The lack of pharmacological therapies to change the prognosis of dementia, emphasizes physical activity methods due to its neurological contributions. However, due to the fact that conventional exercise programs are seen as boring in terms of elderly individuals and the exercise attendance rates are low, the virtual reality (VR) training have been preferred recently. To the best of the investigator's knowledge, there is no study examining the effect of different virtual reality trainings on the spatio-temporal characteristics of the gait, posture and balance. Therefore, the aim of this study is to evaluate the effect of different virtual reality trainings on these parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, virtual reality, exergame, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR 1 Group
Arm Type
Experimental
Arm Description
In this group, participants received standard exercise and exergame training with Microsoft Xbox 360 Kinect for 2 days per week for 6 weeks.
Arm Title
VR 2 Group
Arm Type
Experimental
Arm Description
In this group, participants received standard exercise and exergame training with ALDA balance gear for 2 days per week for 6 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
In this group, participants received only standard exercise for 2 days per week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
exergame
Other Intervention Name(s)
virtual reality, Microsoft Xbox 360 Kinect
Intervention Description
Microsoft Xbox 360 Kinect The exercises were advanced from simple to complex. The program started with exercises in a sitting position. In the next stage, the games requiring weight transfer and use of upper limbs in standing position were continued. The program ended with games that require more complex movements such as lunge and mini squats.
Intervention Type
Other
Intervention Name(s)
exergame
Other Intervention Name(s)
virtual reality, ALDA
Intervention Description
ALDA In the training, games that could be controlled by balance swing, trunk movements and weight transfer in sitting or standing position were used.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Standard Exercise Program The program included warm-up, main exercise and cooling. Warm-up and cooling included neck, trunk, upper-lower extremity range of movement (ROM) exercises and stretching exercises. Main exercise included postural alignment, strengthening for trunk and lower extremity, balance and walking exercises.
Primary Outcome Measure Information:
Title
gait speed
Description
Gait speed was assessed by BTS G-Walk inertial sensor. The sensor, connected to the Lumbal 4-5 intervertebral space via a semi-elastic belt, transfers the spatiotemporal characteristics of the gait to the computer via Bluetooth® 3.0 (G-Studio® software). In our study, participants were asked to walk in a corridor of 8 meters.
Time Frame
change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Spatiotemporal Characteristics of Gait
Description
Spatiotemporal characteristics of gait was assessed by BTS G-Walk inertial sensor. The assessed characteristics were cadence, stride length, left and right step length, step length/height ratio, gait cycle time,stance phase %, swing phase%, double support %, single support %. The sensor, connected to the Lumbal 4-5 intervertebral space via a semi-elastic belt, transfers the spatiotemporal characteristics of the gait to the computer via Bluetooth® 3.0 (G-Studio® software). In our study, participants were asked to walk in a corridor of 8 meters.
Time Frame
change from baseline at 6 weeks
Title
Berg Balance Scale
Description
Berg Balance Scale (BBS) was used to evaluate static balance ability.It is a widely used and validated scale for elderly people. Validity and reliability of BBS in Turkish was established by Sahin et al. The scale includes 14 functional activities such as transfers, turning, taking objects from the ground. Each activity scores between 0-4 and high scores indicate good balance ability.
Time Frame
change from baseline at 6 weeks
Title
Timed Up and Go Test
Description
Timed Up and Go Test (TUGT) was used to assessed dynamic balance ability. Participants were asked to stand up from the chair, walk 3 meters and go back and sit on the chair. Performance time recorded in seconds.
Time Frame
change from baseline at 6 weeks
Title
New York Posture Scale
Description
New York Posture Scale was used to evaluate upright posture. It evaluates head, shoulders, spine, hip and foot alignment in the frontal plane. It evaluates head, thorax, shoulders, upper thoracic region, trunk, abdomen and lower lumbar region alignment in the sagittal plane. In total, 13 regions are evaluated. Each item on the scale gets 1, 3 or 5 points depending on the degree of deviation from the normal. High scores represent a good posture.
Time Frame
change from baseline at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with dementia Mini-Mental State Examination (MMSE) score between 18-23 points Able to walk independently with/without a walking aid (a single point cane) Able to speak and understand Turkish Understand simple commands At least primary education Exclusion Criteria: Severly vision and hearing problems Undergo acute retinal hemorrhage or ophthalmic surgery Acute or chronic neurological problems Musculoskeletal and/or neurological problems affecting movement and balance Vestibular problem and/or use medicine Uncontrolled cardiovascular disease, congestive heart failure, acute myocarditis, pulmonary hypertension, or using a pacemaker Malignancy Orthopedic or neurological surgery in the past 6 months
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

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The Effect of Different Virtual Reality Trainings on Gait, Balance and Posture of Individuals With Dementia

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