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

May 6, 2020 updated by: Ankara Yildirim Beyazıt University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
change from baseline at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
change from baseline at 6 weeks
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.
change from baseline at 6 weeks
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.
change from baseline at 6 weeks
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.
change from baseline at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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