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Completed

NCT Number: NCT04377191

The Effect of 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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exergame

Other

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

Exercise

Other

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 outcomes

  1. gait speed

    Time frame: change from baseline at 6 weeks

    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 outcomes

  1. Spatiotemporal Characteristics of Gait

    Time frame: change from baseline at 6 weeks

    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.

  2. Berg Balance Scale

    Time frame: change from baseline at 6 weeks

    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.

  3. Timed Up and Go Test

    Time frame: change from baseline at 6 weeks

    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.

  4. New York Posture Scale

    Time frame: change from baseline at 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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