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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: exergame; Other: exergame; Other: exercise

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Ankara Yıldırım Beyazıt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR 1 Group; In this group, participants received standard exercise and exergame training with Microsoft Xbox 360 Kinect for 2 days per week for 6 weeks.	Other: exergame; 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.; Other Names: virtual reality; Microsoft Xbox 360 Kinect; Other: exergame; ALDA In the training, games that could be controlled by balance swing, trunk movements and weight transfer in sitting or standing position were used.; Other Names: virtual reality; ALDA; Other: exercise; 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.
Experimental: VR 2 Group; In this group, participants received standard exercise and exergame training with ALDA balance gear for 2 days per week for 6 weeks.	Other: exergame; 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.; Other Names: virtual reality; Microsoft Xbox 360 Kinect; Other: exergame; ALDA In the training, games that could be controlled by balance swing, trunk movements and weight transfer in sitting or standing position were used.; Other Names: virtual reality; ALDA; Other: exercise; 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.
Active Comparator: Control Group; In this group, participants received only standard exercise for 2 days per week for 6 weeks.	Other: exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 6 weeks
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.	change from baseline at 6 weeks
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.	change from baseline at 6 weeks
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.	change from baseline at 6 weeks

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): November 9, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: dementia; gait; virtual reality; exergame
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2019-65; 5444 (Other Grant/Funding Number: Ankara Yildirim Beyazit University Scientific Research Projects Office)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No